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iv I Contents USP42

VOLUMES DM!lary Supplement Chapters 8509

C"""ral Nolk". and R"'Iulr" menb 7105

Inde~ ........................••.. ,.,
Culd" 10 C" n" ral Chapten ............................... 7117
General Infonn.>tion Chaplet"l.. 71.B
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USP 42 Mission and Preface v

Mission and Preface USP

42-NF 37 and Supplements
This section provides background information on the include the combined index, as well as the USP General Notices
United States Pharmacopeial Convention (USP), as well as and the Guide to General Chapters. Volume 1 includes front
general information about the 42nd revision of the United matter (Mission and Preface, People, governance pages and
States Pharmacopeia (USP 42) and the 37th edition of the websites, and Admissions/Annotations) and USP monographs
Natia(1(11 Formulary(NF 31) and their Supplements. Unless A-1. Volume 2 includes USP monographs J-Z. Volume 3 includes
otherwise noted, the text in USP 42-NF 37 is official May 1, Global Heolth monographs, Dietory Supplements monographs,
2019, the text in the First Supplement to USP 42-NF 37 is official NF Admissions/Annotations, Excipient!, and NFmonographs.
August 1, 2019, and the text in the Second Supplement to USP Volume 4 includes general chapters numbered below 1000
42-NF 37 is official December 1, 2019. (General Tests and Assays- including chapter charts),
Reagents, and Reference Tables. Volume 5 includes general
MISSION STAnMENT chapters numbered above 1000 (General Information) and
Dietary Supplements general chapters. General chapters
USP-NF is published in continuing pursuit of the mission of specific to dietary supplements are included in numerical order
USP: To improve global health through public standards and with the rest of the general chapters in USP. Excipient
related programs thot help ensure the quality, safety, and benefit monographs are usually presented in NF but also may
of medicines and foods. appear in USP with suitable cross-referencing when they are
also drug substances. The Excipients section (Volume 3)
HISTORY presents a tabulation of excipients by functional category.
USP has a rich history, dating back to 1820, when 1 1 Supplemen ts-Supplements to USP--NFfoliow a standard
physicians met in the Senate Chamber of the U.S. Capitol schedule each year: the First Supplement is published in
building to establish a pharmacopeia for the United States. February and becomes official August 1 unless otherwise
learn more about USP's history and major milestones on the noted. The Second Supplement is published in June and
USP website (https:l/www.usp.org/about/usp-timeline). he<:omes official December 1 unless otherwise noted. Users of
USP print products must retain Supplements and check the
CONnNT OF USP-NF "Official Text" sec tion of USP's website to have up-to-date
official text. The USP~NF Online is updated with each annual
USP-NFcontains official substance (ingredient) and product revision, Supplement, and Accelerated Revision. The Index in
monographs for official articles recognized in USP-NF (see each Supplement is cumulative and includes citations to the
General Notices 2.20 Official Articles). USP-NF also includes annual revision and, for the Second Supplement, citations to the
monographs for compounded preparations. With few First Supplement. The contents of the two Supplements are
e,.;ceptions, such as articles covered by Global Health integrated into the annual edition of the following year, along
monographs, all articles for which monographs are provided with new official revisions that have been adopted since the
in USP--NF are legally marketed in the United States or are Second Supplement to the previous compendia.
contained in legally marketed articles. Global Health Revisions to USP-NF-USP--NF is continuously revised by
monographs are provided for articles that are not approved or an exceptional process of public involvement and substantial
legally marketed in the United Stat es, bu t that have been interaction between USP and its stakeholders, both
approved by a stringent regulatory authority [as defined by domestically and internationally. Revisions are presented
the World Health Organization (WHO)] and are used for annually in the USP-NF and in twice-yearly Supplements, and
essential purposes in other parts of the world ... as Accelerated Revisions on USP-NF Online [ Errata, Interim
A USP-NF monograph for an official substance, product, or Revision Announcements (IRAs), and Revision Bulletins].
preparation may consist of various components, including the Standard Revisions-USP's standard revision process calls
article's name; definition; packaging, storage, and other for publication of a proposed revision in the Pharmacopeiol
requirements; and a specification. General chapters provide Forum (PF) for a 90-day notice and comment period and,
frequently cited procedures, sometimes with acceptance after the revision is approved by the relevant USP Expert
criteria, in order to compile into one location repetitive Committee, publication in the next USP-NF or Supplement,
information that is applicable to many monographs. See as applicable.
General Notices 3.' 0 Applicability of Standards for more Accelerated Revisions-The Accelerated Revision process is
information about standards contained in USP--NF used to make revisions to USP--NF official more quickly than
monographs and general chapters. through USP's Standard Revision process. learn more about
New and revised monographs and general chapters and Revision Bulletins, Interim Revision Announcements (IRA),
omitted monographs from this edition are indicated in the Errata, and the criteria for and implementation of each on
Admissions section. the USP website (http://www.uspnf.com/official-te..;t).
USP-NF Organization-The USP--NF is published online M odification o f Com pendlal Ref erences--USP and its
as the USP--NF Online. USP-NF is alro printed as a five-volume Expert Committees periodically deem it necessary to modify
set. To faci litate convenient use and reference, all five volumes general chapter titles or similar text that may be referenced in
 www.dl-book.ir

vi Mission and Preface USP 42

other standards throughout the USP-NF. When this occurs, Commentary-For revisions that are published for public
USP staff undertake a rigorous process for identifying and review and comment in PF, the proposal may advance to
updating such references. These updates may occur through official status or be republished in Pffor further notice and
a routine revision, or, in cases in which an update appears to comment. If comments are received, they are considered and
present no significant change in the affected standard, incorporated as appropriate by the Expert Committee(s). In
through a direct update of the referen ce in that standard cases where proposals advance to official status without
without providing an opportunity for notice and comment. In republication in PF, a summary of comments received and the
all cases, USP will publish on its website a notice indicating the appropriate Expert Committee's responses are published in
source change, any resulting references, and whether those the Commentary section of the USP website at the time the
references will be updated through a routine revision or a revision is published.
direct update. The Commentary is not part of the official text and is not
Updating Chemical Informatlon-Updates to the intended to be enforceable by regulatory authorities. Rather,
Chemical Information section at the beginning of it explains the basis of the Expert Committee's response to
monographs occur on an ongoing basis and are not identified public comments. If there is a difference between the contents
wi th revision symbols. Chemical names and molecular weights of the Commentary and the official text, the official text
are updated when a monograph undergoes revision to match prevails. In case of a dispute or question of interpretation, the
the official source, United States Adopted Names (USAN). language of the official text, alone and independent of the
Chemical stru ctures are updated on a continuous basis. Commentary, shall prevail.
Chemical names typically reflect the naming conventions at Print and Electronic Presentations- See General Notices
the time of the monograph development or revision. If the 2.10 Official Text for more information about USP-NFproduct
nomenclature rules of CAS or IUPAC are significantly changed, formats.
the chemical names can be revised or added to implement USP-NF Translat;om- Translations of the USP-NF are
those rules. Molecular weights are derived from the chemical available in Spanish, Russian, and Chinese. The Spanish
formula and are based on the table of atomic weights. Atomic translation is current; other translations are based on previous
weights are recommended by the IUPAC and reflect the revisions of the USP-NF.
isotopic composition of normal terrestrial material. When the USP Reference Stondards-The use of USP Reference
IUPAC recommended values are changed, it is understood that Standards promotes uniform quality of drugs and supports
the changes in molecular weights will be made in due course. reliability and consistency by those performing compliance
Graphical representation of the chemic al compound testing and other users of USP-NF, including manufacturers,
stru ctures is intended as a visual aid to help establish chemical buyers, and regulatory authorities. USP Reference Standards
identity and is understood to represent one of many possible are referenced in specific procedures in both monographs and
ways to depict the molecule. Addition of a graphical general chapters. USP advances this material via careful
representation or changes in such representation, that result characterization studies and collaborative testing, followed by
in the same chemical information, e.g., a flipped chiral review and approval of the compendial use of the reference
molecule or adding a molecule structure, may be introduced material by Expert Committees of the Council of Experts. The
outside of the revision process. It is also understood that in the USP Catalog, which lists the collection of USP Reference
c<lse of t<lutomerism, the rTlol a ule depicted may be one of tile Sl<lmJarl.b, <lflU m ore information about u)e and storage, can
tautomers, but it is intended to represent all isomers in be accessed on USP's website (http://www.usp.org/reference-
equilibrium. Stereogenic centers depicted with plain bonds standards). This program benefits from the widespread
imply mixtures of pertinent stereomers---enantiomer, voluntary contribution of suitable materials and test data from
diastereomers, epimers (anomers), etc. pharmaceutical manufacturers.
Depending on the timing of these updates, users may see
a difference in a chemical structure between the publications USP COVERNINC, STANDARDS-SEnINC, AND
in PF and USP-NF, and between the USP- NF and the USP-NF ADVISORY BODIES
Online.
Shading and Symbols-Shading is used to identify text USP's governing, standards-setting, and advisory bodies
that has been modifted, added, or deleted since it was last include the USP Convention, the Board of Trustees, the
published. Symbols identify the beginning and end of each Council of Experts and its Expert Committees, Expert Panels,
revision or nonharmonized text. The fo!iowing table Subcommittees, Joint Standard-Setting Subcommittees, and
summarizes the types of symbols and the associated subscripts staff. Additional volunteer bodies include Stakeholder Forums
used in USP pubfications: and Project Teams, which offer stakeholders the opportuni ty
to contribute, through advice and recommendations, to. the
advancement of USP's standards and processes. Learn about
Revision Type Revision SY"'boI.>nd Text the composition and work of the USP Convention, Board of
·.""",-,.""., Trustees, Expert Committees, and Expert Panels on the USP
website (https: /lwww.usp.org/ about/convention-
In Proceu Revision (Book or
Supplemenl) ·' ''''''-''''''0) membership). Learn more about Stakeholder Forums and
· • ((>I'-,.""Ol
Project Teams on the USP website (https: /lwww.usp.org/get-
involved/ provide-input/stakeholder.forums). A listing of at!
Interim Revision Announcement

Revisioo Bulletin
·•' (M'+'-"I'"
. c.. ,....,.,,,
current Vo ting Delegates of the USP Convention and members
and Government Liaisons to the Council of Experts and its
Expert Committees and Expert Panels is included in the People
Harmonization ·. section.
Working with the Food and Drug Administration-U SP
Errata •.".. ,....,.''1 works wi th the Secretary of the Department of Health and
•_<0< '...,.'" Human Services, and the principal agency in the Department
Chapter Refelences for this work is the Food and Drug Administration (FDA). USP

Pending •.-
• _«*10 ,.-.,., ,, works in many ways with the agency, but the primary
interaction is through the Government liaison Program. The
Government liaison Program allows representatives of FDA
 www.dl-book.ir
USP42 Mission and Preface vii

and other government agencies to participate in Expert healthcare reform legislation (Biologics Price Competition and
Committee and Expert Panel meetings, enabling interactions Innovation Act, Title VII, Subtitle A of the Patient Protection
between government staff and Expert Committees. Staff in the and Affordable Care Act, Public Law 111 -14B).
FDA Centers who are responsible for review of compendial Dietary Supplements-The Dietary Supplement Health
activities provide specific links and opportunities for exchange and Education Act of , 994 amendments to the FD&:C Act
of comments. The Office of Policy for PharmaceutiCitI Quality provide that a dietary supplement may be deemed a
in the Center for Drug Evaluation and Research provides a misbranded food if it is covered by the specifications of an
primal)' compendial point of contact between FDA and USP. official compendium (e.g., USP-NF), is represented as
conforming to the specifications of an official compendium,
RULES AND PROCEDURES and fails to so conform. This contrasts with pharmaceutical
producu, wherein conformance to applicable compendial
Govern ing Documents-USP-NF standards are standards is mandatory, whether or not the product claims to
recogn ized widely because they are authoritative and science· conform.
based and are established by a transparent and credible
Compounding-USP provides general chapters and
process. See the Articles of Incorporation section in this book; monographs for compounded preparations, as well as
the Bylaws (https://www.usp.org/about/convention. monographs for bulk substances used in compounding. USP
membership/bylaws), and the Rules and Procedures of the
standards are recognized in various provisions of the FD&C Act
Council of b1perts (https:/Iwww.usp.org/about/leadership/ and such provisions do not differentiate between
policies-rules). Collectively, these documents serve USP manufactured and compounded medicines.Moreover, the
volunteers and staff as the governing principles for USP's
FD&C Act and the 2013 Drug Quality and Security Act
standards·setting activities. specifically reference USP standards (or compounding. Learn
more about compounding on the USP website (https:/1
LEGAL RECOGNITION www.usp.org/compounding).
Recognition of USP-NF--USP-NF is recognized by law and Medical Devices-Section 201 (h) of the FD&C Act defines
custom in many countries throughout the world. In the United a device as an instrument, apparatus, similar article, or
States, the Federal Food, Drug, and Cosmetic Act (FD&C Act) component thereof recognized in USP-NF. Section 502(e) of
defines the term "official compendium" as the official USP, the the FD&C Act defines the established name of a device in the
official NF, the official Homeopathic Pharmacopeia of the United absence of an FDA designation of the official name as the
States, or any supplement to them. USP-NF standards playa official title in an official compendium. Despite these statutory
role in the adulteration and misbranding provisions of the provisions, there is no comparable recognition of USP's role in
FD&:C Act, which apply as well to biologics, a subset of drugs, establishing compendial standards for medical devices as
under the Public Health Service Act (see General Notices 2.30 exists for drugs and biologics. Under authority granted by the
Legal Recognition). Food and Drug Administration Modernization Act of 1997, the
FDA requires that names for articles that are not official must Center for Devices and Radiological Health recognizes national
be clearly distinguished and differentiated from any name and international standards, including some uSP tests and
recognized in an official compendium. Drugs with a name assays, for medical devices.
recognized in USP-NF also will be considered misbranded Nomenclature-For information on the nomenclature
unless they meet compendial standards for packaging and development process, the Nomenclature and labeling Expert
labeling (see General Notices 3. I O. 1.0 Applicability of Standards Committee, and USp's work with United States Adopted
to Drug Products, Drug Substances, and Excipienrs for more Names (USAN), see the USP website (https:/Iwww.usp.org/
information). expert-committees/nomenclature.and.labeling.expert.
Drugs-USP's goal is to have substance and drug product committee·work.plan).
monographs in USP-NFfor FDA·approved drugs in the United Chemical Names and CAS Registry Numbers-Chemical
States, including chemical and biologic medicines, and their subtitles given in the monographs are index names used by
ingredients. USP also provides monographs in USP-NFfor the Chemical Abstracts Service (CAS) of the American
legally marketed therapeutic products not approved by FDA, Chemical Society. They are provided only in monographs in
e.g., pre·1938 drugs, over·the·counter (OTC) drugs marketed which the titles specify substances that are definable chemical
under FDA's OTC Monograph system, dietary supplements, entities. The first subtitle is the inverted form of the systematic
and compounded preparations. The G/obol Health section of chemical name developed by CAS for the purpose of the
USP-NF contains monographs for articles that are not Collective Index (0). The second subtitle, given in uninverted
approved or legally marketed in the United States, but that form, is a preferred IUPAC name (PIN) sanctioned and used by
have been approved by a stringent regulatory authority (as the International Union of Pure and Applied Chemistry
defined by WHO) and are used for essential pU{poses in other (IUPAC). Preferred IUPAC names also are used by the WHO.
parts of the world. Conformance with a USP-NF monograph, Occasionally a third subtitle is supplied for historical reasons
if applicable, is required at all times in the life of an article from or when the synonym uses an alternative, but equivalent,
production to expiration. naming convention. Monographs with chemical subtitles also
Biologics-In the United States, biologics are considered to generally carl)' CAS registry numbers. These bracketed
be a subset of drugs, whether they are approved by FDA under numbers function independently of nomenclature as invariant
the FD&C Act [and receive a new drug application (NDA)] or numerical designators of unique, unambiguous chemical
under the Public Health Service Act [PHS Act, where they substances in the CAS registry, and thus are convenient and
receive a biologics license application (BLA)]. As a result, aU widely used.
PHS Act biologics are subject to the applicable drug regulatory
requirements of the FD&:C Act, which means they are required HARMONIZATION ACTIVITIES
to c.omply with the adulteration and misbranding provisions USP participates in several collaborative activities with
of the FD&C Act, including USP-NFcompendial requirements, global pharmacopeias in both bilateral and multilateral
to the extent that such requirements apply to a particular settlngs. Examples of USP's current activities include the
biologic product.This is equally so for biologics approved following.
under the long-standing PHS Act "351 (a)H pathway, as well as Pharmacopelal Discussion Group-USP harmonizes
the new "351(k)" pathway for biosimilars added by the 2010 pharmacopeial excipient monographs and general chapters
 www.dl-book.ir
viii Mission and Preface usp 42

through the Pharmacopeial Discussion Group (PDG), which regulatory agencies, and other stakeholders to assess
includes representatives from the European, japanese, and conformance of herbal medicinal ingredients with
United States pharmacopeias, and WHO (as an observer). independent public standards and to control the quality of
According to the PDG definition, Na pharmacopeial general articles moving in international commerce. The HMC is
chapter or other pharmacopeial document is harmonized available at https:/Ihmc.usp.org.
when a pharmaceutical substance or product tested by the USP Dietary Supplements Compendium-The Dietary
document's harmonized procedure yields th e same results, Supplements Compendium combines, in a two-volume set,
and the same accept/reje<t decision is reached." Information USP-NF standards for dietary supplements, standards and
regarding PDG, including history, the PDG working information from the Food Chemicals Codex, regulatory and
procedure, a glossary, and lists of monographs and general industry documents, and other tools and resources. It is
chapters that have completed stages 1-4 of the published every three years as a hardcover print edition.
pharmacopeial harmonization process, resulting in an Food Chemicals Codex-The Food Chemicals Codex (FCQ is
approved USP Stage 4 Harmonization text, is available on a compendium of internationally recognized monograph
USP's website (https://w.-.w.usp.org/harmonized-standards). standards and tests for the purity and quality of food
International Meeting of the World Pharmacopeias- ingredients, e.g., preservatives, flavorings, colorings, and
USP works with WHO and global pharmacopeial partners on nutrients. FCC is published every two years, with supplements
the strategy and establishment of Good Pharmacopoeial every six months, and is available in print and electronic
Practices (GPhP) as a set of guiding principles for the formats. Proposed revisions to FCC are available for public
appropriate establishment of pharmacopeial standards. viewing and comment through the FCC Forum. The FCC Forum
Adopt/Adapt Agreements-USP grants the rights to copy can be accessed free of charge at http://
and/or adapt USP standards for use in other pharmacopeias W'W'W.foodchemicalscodex.org.
through this formal mechanism.
Bilateral Agreements-USP partners with pharmacopeias OTHER USP RESOURCES
for the joint development of pharmacopeial standards using
Chromatographic Columns-This comprehensive
this informal process.
USP Exchange Programs-USP regularly welcomes the reference, previously titled Chromatogrophic Reagents,
exchange of scientific personnel through this program, with provides detailed information needed to conduct
chromatographic procedures found in USP-NF.
the goal of sharing scientific knowledge among global
organizations involved in standards setting and the effective Chromatogrophic Columns lists the brand names of the column
use of standards. reagents ci ted in every proposal for new or revised gas- or
liqUid-chromatographic analytical procedures that have been
published in PF since' 980. Chromatographic Columns also
OTHER USP COMPENDIA helps to track which column reagents were used to validate
USP Compounding Compendium-The U5P Compounding analytical procedures that have become official. The branded
Compendium is an electronic compendium that includes all column reagents list is updated bimonthly and maintained on
compounding-rela ted general chapters from the USP-NF as USP's website.
well as the supporting general chapters that are referenced in USP Dictionaf)'-The USP Dictionary of USAN and
the compounding general chapters and in USP-Nf General International Drug Names provides, in a single volume, the
Notices. The purpose of the USP Compounding Compendium is most up-to-date United States Adopted Names of drugs;
to provide compounding practitioners with convenien t access official USP-NF names; nonproprietary, brand, and chemical
to associated general chapters. names; graphic formulas; molecular formu las and weights;
USP Herbal Medicines Compendium-The USP Herbal CAS registry numbers and code designations; drug
Medicines Compendium (HMC) is an online compendium that manufacturers; and pharmacologiC and therapeutic
helps ensure the quality of the herbal ingredients used in categories. The Dictionary helps to ensure the accuracy of the
herbal medicines. HMC monographs provide quality following: product labeling; reports, articles, and
specifications-tests, procedures, and acceptance criteria---- correspondence; FDA regulatory filings; and pharmaceutical
with validated analytical procedures and allied reference package inserts. It is published annually. For more information
materials that aid in conformity assessment. HMC can help about the Didionary see the USP website (https:/1
ingredient manufacturers, herbal product manufacturers, W'W'W.usp.org/products/usp-dictionary).
 www.dl-book.ir
USP 42 People I Committees ix

People

2015-2020 Revision Cycle

Officers of the USP Convention, Board of Trustees,
and the Council of Experts, Expert Committees,
Expert Panels, and Advisory Groups

Bethesda, MD
Officers (2015-2020) Susan C. Winckler, R.Ph., J.D.
Trustee At-Larqe
Jesse l. Goodman, M.D., M.P.H. Alexand ria, vA
President Ron T. Plervlncend, Ph.D.
Washington, DC Chief Executive OffICer, February 20' 4-present
Tlmotfiy R. Franson, B.S. Pharm., M.D. (ex-officio)
Past President Rockville, MD
Indianapolis, IN
John E. Courtney, Ph.D.
Treasurer Council of Experts (2015-2020)
Bethesda, M D
Susan S. de Mars, J.D. ,aap Venema, Ph.D_
Secretary Chair, Council of Experts
Rockville, M D Rockville, MD
Richard A. Blessing, M.S.
Chair, Chemical Medicines Monographs'
Board of Trustees (2015-2020) North Chicago, Il
Edward K. Chess, Ph.D.
Thomas R. Temple, B.S. Pharm., M.S., F.A. Ph.A. Chair, Biologics Monographs 3--Complex Biologics
Chair McHenry, Il
Trustee At-Large Stephanie Y. Crawford, Ph.D., M,P.H.
Des Moines, rA ... Chair, Nomenclature and Labeling
Gregory E. Amidon, Ph.D. Chicago, Il
Trustee Representing the Pharmaceutical Sciences Gigi S. Davidson, B.S. Pharm., DICVP
Ann Arbor, M I Chair, Compounding
laura Herman, M.B.A., M.A. Raleigh, NC
Trustee Representing the Public Michael R. De Fellppls, Ph.D.
New Canaan, CT Chair, Biologics Monographs' -Peptides
Robert J. Meyer, M.D. Indianapolis, IN
Trustee Representing the Medical Sciences James E. De Muth, Ph.D., R.Ph.
Charlottesville, VA Chair, General Chapters- Dosage Forms
Marilyn K. Speedle, Ph.D_ Madison, WI
Trustee Representing the Pharmaceutical Sciences Jonathan W. DeVries, Ph.D.
Mjnneapolis, M N Chair, Food Ingredients
Stephen P. Spielberg, M.D., Ph.D. Golden Valley, M N
Trustee Representing the Medical Sciences Dennis E. Doherty, M.D., FCCP
Chair, Healthcare Quality
UPP'" Gwyo"'d, PA Lexington, KY
GaU R. Wilensky, Ph.D.
Trustee At-Large Relnfiard Walter, Ph.D.
Chair, Chemical Medicines Monographs 6
 www.dl-book.ir
x Committees I People USP 42

Morristown, NJ Seigelchifer, Ph.D .; Ofelia Villalva·Rojas; Caroline R.

Mary G. Foster, Pharm.D., BFA Welnstein·Oppenheimer, Ph.D.
(hD/r, General (hopters--Pockoging and Distribution
Blue Bell, PA
Dennis K.J. Gorec:kl, B.S.P., Ph.D. Expert Committees for the United
Chair, Non-Botanical Dietary Supplements
Saskatoon, Saskatchewan, Canada States Pflannacopela
Xlaorong He, Ph.D.
Choir, General Chopters--Physicol Analysis Nome nc:iature and labeling
Ri dgefield, CT STEPHANIE Y. CRAWFORD, PH.D., M.P.H., Chair
Mary C. Houck, Ph.D. Mary B. Baker, Pharm.D.; Dawn M . Boothe, D.V.M., Ph.D.;
Chair, Excipient Monographs 2 Mike Cohen, M.S.; Elizabeth Igne Ferreira, Ph.D.; Karen
Norman, OK Hauda, J.D., M.S.; Kent Johnson, M.Pharm.; Armen
David Hussong, Ph.D. Melikian, Ph.D.; Ajay Parashar,. M.S.; Ginette A. Pepper,
Choir, General Chaptm-Microbiology R.N., Ph.D., FAAN; Thomas Reinders, Pharm .D.; Joanne
KenSington, MD G. Schwartzberg, M.D.; Maged Sharaf, Ph.D.; Eric
Kim C. Huynh· Ba, M.S. Sheinin, Ph.D .; Thomas nce, Ph .D .; Claudia Vincenzi,
Chair, Chemical Medicines Monographs 4 Ph.D., Pharm.D.; Gillian Woollett, Ph.D.
Newark, DE
Amy J. Ka rren, B.Sc. Pronunciation Expert Panel
Cho", Chemical Medicines Monographs 5 WlUlAM M. HELLER, PH.D., Chair
Flagstaff, AZ Mary B. Baker, Pharm.D.; Stephanie Y. Crawford, Ph.D.;
Nancy Lewen, B.Sc. Doreen J. Elston, Pharm.D.; Kent Johnson, M .Pharm.;
ChOir, General Chapters-Chemical Analysis David F. l ong, Ph.D.; Joan c. May, Ph.D.; Anthony
Indianar.:lis, IN Palmieri, Ph.D.; GinetteA. Pepper, R.N ., Ph.D., FAAN;
Ro bin . Maries, B.Sc., M.Sc., Ph.D. Thomas P. Reinders, Pharm.D.
Chair, Botanical Dietary Supplements and Herbal Medicines
Ottawa, Ontario, Canada Healthcare Quality
Mlc:hael G. Mulkerrin, Ph.D. DENNIS DOHERTY, M.D., FCCP, Choir
Chair, Blo/oqics Monographs 2--Proteins nmothy Albertson, Ph.D.; Phil Ayers, Pharm.D.; Danial
Hillsborougn, CA EdWin Baker, Pharm.D.; Mark Decerbo, Pharm.D.; Peter
Eric: Jon Munson, Ph.D. Glassman, M .B.B.S.; Roy Guharoy, Pharm .D., M .B.A.;
Chair, Excipient Monographs' Raymond Hohl, M.D.; Oua'.le Kirking, Ph.D.; Raymond
l exington, KY l ove, Pharm.D.; Marcus Reldenberg, M .D.; Melody
Bemard A. Olsen, Ph.D. Ryan, Pharm .D.; Joanne Schwartzberg, M.D.; Patricia
Chair, Chemical Medicines Monographs 3 Sokol, J.D.; J. Russell Teagarden, D.M. H.; Jeanne Tuttle,
Wake Forest, NC B.S. Pharm.; Terri Warholak, Ph.D.; Hsiang Shonna Yin,
Emest Parente, Ph.D. M.S.
Chair, Chemical Medicines MonQ9raphs 2 Drug Allergy and Intolerance Classlflc:atlon Expert
Saint louis, MO Panel
Robert R. Singer, M.S. RAYMOND LOVE, PHARM .D., Chair
Chair, General Chapters-Statistics Dennis Doherty, M.D., FCCP; Gay Dolin, M.S.N.; Roy
Union City, CA Guharoy, Pharm.D., M.B.A.; Robert Hausam, M.D.;
Reinhard Walter, Ph.D. Ru ssell leftwich, M.D.; Robert McClure, M.D.; Geral d
Chair, Chemical Medicines Monographs 6 McEvoy, Pharm.D.; Tejal Pa tel, Pharm.D.; Seth Powsner,
Whippany, NJ Ph.D.; George Allen Robinson, B.S. Pharm; Shelly Spiro,
Wesley E. Workma n, Ph.D. B.S. Pharm
Chair, General Chapters-Biological Analysis
Saint Charles, MO Exc:hange of Compounded Drug Preparation
Information In Health IT System Expert Panel
ROY GUHAROY AND RICHARD PARRISH, PH.D., Co-Chairs
Expert Committees (2015-2020) David Aguero, Pharm.D.; Sandra Benavides, Pharm.D.;
Scott louis Ciarkowski, Pharm.D.; Catherine Graeff,
M.S.; John Thomas Kilbourne, M.D.; Leanne Murray,
rNOTE- The following listing of Expert Committees Pharm.O.; Tammy Phyllis Powell, M .S.; Seth
Includes the Expert Panels that serve in an advisory Strawbridge, Pharm.D.
capacity to the specific Expert Committee. The listing
of Expert Panels and their membership represents Health Literacy Expert Panel
those that have been fu lly formed and approved as of JOANNE G. SC HWARTZBERG, M.D., Chair
July 2015 . Expert Panels are continuously formed and Cindy Brach, MPP; joseph Chebli,.Pharm.D:; Nicole Coo~,
concluded throughout the USP revision cycle, and Ph.D.; Terry DaVIS, Ph.D.; Radhlka DevraJ, Ph.D.; De~ms
other membership listings will appear in the future.] Doherty, M.D., FCCP; Gerald McEvoy, Pharm.D.; Juliet
N guyen, Pharm .D.; Ruth Parker, M.D.; Seth Powsner,
Ph.D.; N. l ee Rucker; Patricia Sokol, J.D.; J. Ru ssell
Expert Panels for the Council of Teagarden, D.M.H.; Keith Trettin, B.S. Pharm; Hsiang
Shonna Yin, M .S.
Experts Executive Committee
Model Guide lines for All Ma rketed Products
, Spanish Translation Expert Pane l Expert Panel
OSCAR QUATTROCCHI, M.SC., Chair DUANE M. KIRKING, PH.D., Chair
Ofelia Espejo, Ph.D.; Monica I. Hirschhorn, M.Sc.; Francisco Daniel E. Baker, Pharm.D.; Dennis Doherty, M .D., FCCP;
Kuribrena; Pilar Pais, Ph.D.; Jose Marfa Parisi, M.Sc.; Luisa . lauren Hoffman, Pharm.D .; Gerald McEvoy, Pharm.D.;
Ft:rmmud Pont-.:! D'Lt:6n Quiroga, Ph.D.; Maurido A. Seth Powsner, Ph.D.; N. Lee Rucker; Brian Solow, M.D.;
 www.dl-book.ir
USP 42 People I Committees xi

J. Russell Teagarden, D.M.H.; Jeanne Tuttle, B.S. Pharm; Non-Radioactive Imaging Agents Expert Panel
Dennis West, Ph.D. IEROME M. LEWIS, PH.D., Chair
Francisco A9.uilar-Parrilla, Ph.D.; James Walter Brodack,
Parenteral Nutrition Safety Expert Panel Ph.D.: Dilip R. Choudhury, Ph.D.; Francette Delaloge,
PHIL AYERS, PHARM.D., Chair Ph.D.; Joseph loui~ Glajch, Ph.D.; ~rnest Victor Groman,
Mary B. Baker, Pharm.D.; Elizabeth Bobo, M.S.; Denise Ph.D.; Gordon Cr,ug HIli, Ph.D.; K.m Huynh-Ba, M.S.;
Bohrer, Ph.D.; Jo~eph Boullata, Pharm.D.; Mark Decerbo, Aurelie Mieze-Richard, Pharm.D.; Patrick Noland, M.S.;
Pharm.D.; Dennis Doherty, M .D., FCCP; Kathleen M . Scott Roberts
Gura, Pharm.D.; Deborah Houston, Pharm.D.; Matthew
T. Jenkins, M.S.; Gordon Scott Sacks, Pharm.D.; Maureen Radloac:tlve Drugs Expert Panel
Schanck, Pharm.D.; David Seres, M .D.; Connie Rae JAMES A. PONTO, M.S., Chair
Sullivan, B.S. Pharm; Patricia Worthington, M.S.N. Corinne Berisimon, Ph.D.; Jonathan M. Fitzsimmons, Ph.D.;
Umesh Gangadharmath, Ph.D.; Kim Huynh-Ba, M .S.;
Chemical Medicines Monographs 1 Thijs Kroon, 'Phaml. D.; Adrian Nunn, Ph.D.; David Pipes,
RICHARD A. BLESSING, M.S., Chair Ph.D.; Kara Weatherman, Pharm.D.; Martin Williamson,
Gennady Ananchen ko, Ph.D.; Elizabeth (Betsy) Cariello; Ph.D.; Steve Zigler, Ph.D .
Alain Duguet, Ph.D.; Leslie Furr, M.S.; Rupa Iyer, M.S.;
Monika Jain, Ph.D.; Greg Kaster, M .S.; Jasmina Chemical Medicines Monographs 5
Novakovic, Ph.D.; Naidu Petla, Ph.D.; Jeff Rohrer, Ph.D.; AMY I. KARREN, Chair
David Schuck, Ph.D.; Nilesh Shinde, M.S.; Jan Srbek, D.J. Doan, ~.S;. Sushil Gangw~l, Ph.D.; Ass~d Kazeminy,
Ph.D.; Giordano Traui, Ph.D. Ph.D.; Min LI, Ph.D.; Judy Lin, M.S.; Pau line McGregor,
Ph.D.; Marian Meyer, Ph.D., M.B.A.; Jonathan Parks;
Chemical Medicines Monographs 2 Justin Pennington, Ph.D .; Vijaya Ramesh, B.Pharm.;
ERNEST PARENTE, PH.D., Chair Gurvinder Singh Rekhi, Ph.D.; Iffaaz Salahudeen, Ph.D.;
Mahmoud AlOma ri, Ph.D.; Allan Bokser, Ph.D.; Matthew Mary W. Seibel; Hameraj Singh, Ph.D.; Michael Skibic,
Borer, Ph.D.; Jama Elmi, Ph .D .; Michael Koberda, Ph.D.; M.S.
Joan c. May, Ph.D.; Beth Minter; Maria Ines Santoro,
Ph.D.; Jeff Schwartzenhauer, M .S.; Dennis Stephens, Chemical Medicines Monographs 6
Ph.D.; Sumath i V. Rao, Ph.D.; Luciano Virgili, !:'h.D.; REINHARD WALTER, PH.D., Chair
Zhenyu Wang, Ph.D.; Joseph Yakupkovic, Ph.D.; Patrick Seamus Boland; Robert Graham Buice, Ph.D., M.B.A.;
Vat, Ph.D. Timothy Gil.mor, Ph.D.; Carmen .Gonzalez, .P~ . D.; John
Joseph Hernes, Ph.D.; Todd leWIS, M .S.; Wilham Long,
Chemical Medicines Monographs 3 Ph.D.; Phil Neth ercote, Ph.D.; Raphael Omaf, Ph.D.;
BERNARD A. OLSEN, PH.D., Chair David Hitchcock Rogers, Ph .D.;Thomas Rosanske, Ph.D.;
Samuel Akapo, Ph.D.; Bian<;a Avramovitch, Ph.D.; Amy Donna S Seibert, Ph.D.; Christina Szabo, Ph.D.; Reinhard
Barker, Ph.D.; l ynn Blessing, M .S.; Thomas Broadbent, Walter, Ph.D.; Xiaoping Wang, Ph.D.; Kylen Whi taker,
Ph.D.; Ian Chung, Ph.D.; Debashis Das, Ph.D.; Jeffrey Ph.D.; Zeena Williams, Ph.D.
Fleitman, P.h.D.; Yur( Goldberg, Ph.D.; Eric Kesslen,
Ph.D.; Pauline lacr01x, M.S.; Donald Parsons, Ph.D.; Ac:etamlnophen OTC Expert Panel-CONClUDED
David Reed, M.B.A.; Murugan Saravanan, M .S .; Joseph KYtEN WHITAKER, PH .D., Chair
Stowell, Ph.D. Tina .M. Engel, Ph.!J.; David A. ~ay, Ph.D.; Saulius A. Gylys;
MlchaelT. Rankin, M .S.; Da Vid H. Rogers, Ph.D .; Gregory
Chemical Medicines Monographs 4 K. Webster, Ph.D.; Jonathan Zeszotarski, Ph.D.
KIM C. HUYNH-BA, M.S., Chair
Josep Maria d e Ciurana Gay, M.S.; Simona Dragan, Ph.D.; Biologics Monographs l-Pe ptldes
Natalia Borisovna Epshtein, Pharm.D., M.S.N.; Quanyin MIKE DE FELiPPIS, PH.D., Chair
Gao, Ph.D.; Jerome M. lewis, Ph.D.; Oscar Uu, Ph .D.; WilfriedArz, Ph.D.; Chaim Eidelman, Ph.D.; Gyongyi Gra.tzl,
Annarapu Malleswara, Ph.D.; Mariann Neverovitch, Ph.D.; Gerhard Haas, Ph.D.; Morten Hach, M.S.; Manon
M.S.; Patrick Noland, M .S.; James A. Ponto, M.S.; King, Ph.D.; Peter larson; Jean-Marc Poudrel, Ph .D.;
Hemant Kumar Sharma, Ph.D.; William Taraszewski, Harold Rode, Ph.D.; Raimon Rubires, Ph.D.; Zachary
Ph.D.; Martin Williamson, Ph.D.; Min Xia, Ph.D.; Steve S. Shriver, Ph.D.; Ved Srivastava, Ph.D.; Michael Verlander,
Zigler, Ph.D. Ph.D.
(821 ) Identlflcatlon and Assay of Radlonuclldes and Glatlramer Expert Panel
(1821) Radioactivity Theory and Practice and (1823) GYONGYI GRATZL, PH.D., Chair
Drugs for Positron Emission Tomography Expert Joseph Louis Glajch, Ph.D.; Satyanarayana Kota, Ph.D:;
Panel-CONCLUDED Barbara Mulloy, Ph.D.; Todd A. OSlek, Ph.D.; MarCia
SALLY W. SCHWARZ, M.S., Chair ., Cecilia Rusjan; Rakesh Singh Shekhawat, Ph.D.; Zachary
Cathy Sue Cu tler, Ph.D.; Jonathan M. Fitzsimmons, Ph. D.; Shriver, Ph.D.; Rene Thuermer, Ph.D.; Patrick Vallano,
Paula M. Jacobs, Ph.D.; Thijs Kroon, Pharm.D.; Jerome Ph.D.; M ichael Verlander, Ph.D; Vera Weinstein, Ph.D.
M . Lewis, Ph.D.; Roger Moroney, M.S.; James A. Ponto,
M .S.; Duann V. ThistJethwaite, B.S.; Steven S. Zigler, Glucagon Expert Panel-CONCLUDED
Ph.D. HAROlD RODE, PH.D., Chair
Jan Amstrup, Ph. D.; Matthew W. Borer, Ph.D.; Gerhard
(825) RadJopharmaceutlcais Compounding Chapter Manfred Haas, Ph.D.; Anne M unk Jespersen, Ph.D.;
lAMES PONTO, M.S., Chair Elizabeth Kramer, Ph.D.
David Barnes, B.S. Pharm; Allegra DePietro, M.S.; Wendy
Galbraith, Pharm.D.; Fred Patrick Gattas, Pharm.D.; Insulin Expert Panel
Richard lewis Green, B.S. Pharm; Brenda Sue Jensen, HEATHER BOUX, PH.D., Chair
M .A.; Patricia C. Kienle, M .P.A.; Vivian Sue loveless, Jan Amstrup, Ph.D.; Wilfried Arz, Ph.D.; Chris Burns, Ph.D.;
Pharrn.D.; Paul Bany Mahan, B.S. Pharm; Rezaul H. Jill Crouse-Zeineddini, Ph.D.; Morten Hach, M .S.;
Mannan, Ph.D.; Steve Zigler, Ph.D. Elizabeth Kramer, Ph.D .; Karthik Ramani, Ph.D.; Sarah
Richer; Harold Rode, Ph.D.
 www.dl-book.ir
xii Committees I People USP 4 2

Biologics Monographs 2--Prote lns Bioassay General Chapter

MICHAEl MULKERRIN, PH.D., Chair DAVID LANSKY, PH.D., Chalf
Gregory Beck, Ph.D.; Heather Boux, Ph.D.; Chris Burns, jan Amstrup, Ph.D.; Walter Hauck, Ph.D.; Bhavin Parekh,
Ph.D.; Frederic Carriere, Ph.D.; Michel Girard, Ph.D.; Ph.D.; Andrew Rugaiganisa, M.S.; Perceval Sondag,
Anne M u nk Jespersen; Sridevi ~hambhampaty, P~.D.; M.S.; Ralf Stegmann, Ph.D.; Ryan Yamagata, M.S.;
Roht>rt Mayer, Ph.D.; Ned Mozier, Ph.D.; Dhanan)ay Lingm in Zeng, Ph_D .
Patankar, Ph.D.; Mauricio Seigelchifer, Ph.D.; jill Crouse-
Zeineddini, Ph.D. Biologics Stability Expert Panel
ANTHONY MIRE-SLUIS, PH.D., Chair
Enzyme Expert Panel Kimberly Cheung, M.S.; Nila Das, Ph.D.; Stephanie Ferrari,
FREOERIC CARRI~RE, PH.D., Chair M.S.; lens Krogh Rasmussen, M.S.; Joseph Kutza, Ph.D.;
Gregory Beck, Ph.D.; Francis Dwulet, Ph.D.; Olaf Friedrich, Lori A. McCaig, Ph.D.; Cornelia Nickenig; Nausheen
Ph.D.; Lu igi Giovanni Ghidorsi; Christopher Hosty, M.S.; Rahman, Ph.D.; Camilla Santos, Ph.D.; Michael Walsh,
Vincent jannin; Andreas Koerner, Ph.D.; Thomas K. M.S.; Allison Wolf, M.S.
langdon, B.Se.
Cell Banking Expert Panel
Fc Function Assays Expert Panel ROBUT BELL, PH.D., Chair
IILL CROUSE-ZEINEDDINI, PH.D., Chair jeri Ann Bosse, Ph.D.; Su nil Gairola, Ph.D.; Anne Gondran,
Shan Chu ng, Ph.D.; Marina Feschenko, Ph.D.; Scott Kuhns, Ph. ~ .; luhong He, ~h.D.; Ru,ud Hulspas, Ph.D.; Jette Dina
Ph.D.; l eeAnn Machiesky, M.S.; Veena Pai Raiker, Ph.D.; Krelb erg, Ph.D.; Michael laird, Ph.D.; l ye Th eng Lock,
Bhavin Parekh, Ph.D.; Teresa Surowy, Ph.D.; Max Tejada, Ph.D.; Archie Lovatt, Ph.D .; Sam Yaghmour, M.S.; Earl
Ph.D. Zablackis, Ph.D.
Biologies Monographs J-Co mplex Biologics Residual DNA In Biotechnology-Derived Products
EDWARD K. CHESS, PH.D., Chair Expert Panel
Mehrshid Alai, Ph.D.; Pascal Anger, Ph.D.; Paras too Azadi, WESUY E. WORKMAN, PH.D., Chair
Ph.D.; Svet lana Bergelson, Ph.D.; Barbara Blum, Ph.D., Pascal R. Anger, Ph.D.; jon R. Borman; Scott Kuh ns, Ph.D.;
M.P.H.; Mirella Ezban, Ph.D.; Elaine Gray, Ph.D.; Donald Weihong Wang, Ph.D.; judith Zhu-Shimoni, Ph.D.
Macl ean, Ph.D.; Nicole Provost, Ph.D.; Elizabet h I. Read,
M.D.; Peter Vandeberg, Ph.D.; Christian Viskov, Ph.D.; Vaccine Polysaccharide NMR Identity Testing
Darin Weber, Ph.D. Expert Panel
CHRISTOPHER lONES, PH.O., Chair
Bovine Unfractlonated Heparin Expert Panel-- Yves Aubin, Ph.D.; Francesco Berti, Ph:D.; Crist iana Campa,
CONCLUDED Ph.D .; Thomas P. Jacques, Ph.D.; MIChael T. jones, Ph.D .;
WfSLEY E. WORKMAN, PH.D., Chair jeremy P. Kunkel, Ph.D.; Neil Ravenscroft, Ph.D .; Philippe
Tania Andrade, B.S. Pharm.; Irene Bartoli, B.Se.; Maria Talaga, Ph.D.; Earl Zablackis, Ph.D.
l eticia Bertot, Pharm.D.; Elaine Gray, Ph.D.; Marco
Guerrini, Pharm.D.; Kristian johansen, Ph.D.; Robert Validation of Commercial Test Kits Expert Panel-
Linhardt, Ph.D.; Barbara Mulloy, Ph.D.; Marilene Nuss CONCLUDED
Ran~e l; Zachary Shriver, Ph.D.; Pearle Torralba, Ph.D.; KENNETH MILLER, PH.D., Chair
ChrIS tian Viskov, Ph .D. Heather Boux, Ph.D.; David Good, M.S.; Wendy Saffell·
Clemmer, M.S.
CD-J4 Positive Cells Expert Panel-CONClUDED
NICOLE M. PROVOST, PH.D., Chair Viral Vaccines Expert Panel
Ruud Hulspas, Ph.D.; Elizabeth I. Read, M.D.; Michael D. EARL ZABLACKIS, PH.D., Chair
Rosu-Myles, Ph.D.; Luisa Saraiva, Ph.D.; Richard J. l uca Benetti, Ph.D.; Sun il Gairola, Ph.D.; Lucy Gisonni-lex,
Stebbings, Ph.D.; D. Robert Sutherland, M.Se.; Uri M.S.; Keith Howard, Php.; Christophe~ jones, Ph.D.;
Wang, Ph.D.; Albertus W. Wognum, Ph.D. Archie Lovatt, Ph.D.; B(li Patel, Ph. D.; Sllke
Schepelman n, Ph.D.; Vaneet Sharma, Ph.D.; Mark Van
Low Molecular Weight Heparlns Expert Panel DOij, Ph.D.
ELAINE GRAY, PH.D., AND EDWARD K. CHESS, PH.D., Co-Chairs
Nicolas C.R. Amiot, Ph.D.; Christopher P. Bryant, Ph.D.; General Chapters-Chemical Analysis
Ishan Capila, Ph.D.; Venkatesan S. Chidambaram, Ph.D.; NANCY LEWEN, B.se, Chair
Gyongyi S. Gratzl, Ph.D.; Kristian johansen, Ph.D.; An thony Bevilacqua, Ph.D.; Christoph~r Burgess, Ph.D.;
Annarapu Malleswara, Ph.D.; Barbara Mulloy, Ph.D.; Robert Cam bron, Ph.D.; Thomas DIFeo, Ph.D .; john
Anna K.Y. Nordin; Bruna Parma, M.Se.; Zachary Shriver, Dolan, Ph.D.; joseph Louis Glajch, Ph.D.; john
Ph.D.; Christian Viskov, Ph.D. Hammond; john Hinshaw, Ph.D.; Bren t Kleintop, Ph.D.;
Steven Leinbach, M.S.; Gregory Martin, M.S.; Nuno
Biologics Monographs 4-Antlblotlc, Matos, B.Se; Oscar Quattrocchi, M.Se.; Helmu t
PASCAL ANGER, PH.D., Chair Rockstroh, Ph. D.; Mark Schweitzer,. Ph.D.; Timot hy .
Elizabeth (Betsy) .Bruce Cariello, B.A.; Sheila Deneau, B.Se; Shelbourn, M.S.; Rostyslaw D. Slablcky, B.Se; Ten Soh,
Colleen Guthrie, B.Se; Robert Klassen, M.S.; Mark G. Ph.D.; Kevin A. Swiss, Ph.D ., Timothy j. Wozn iak, Ph.D .
Papich, M.S.; Cindy Reid, B.Se; jennifer jaye Schimmel,
M.D.; jonathan A. Stewart, B.Se; Yaozuo Yuan, Ph.D. Analytical Methodologies Based on the Light
Scattering Phenomena Expert Panel
General Chapters-Biological Analysis KEVIN SWISS, PH.D., Chair
WESLEY E. WORKMAN, PH.D., Chair Emilia Byrne, M.S.; Nila Das, Ph.D.; joseph Louis Glajch,
Robert Bell, Ph.D.; Mahesh Bhalgat, Ph.D:i Chris.topher Ph.D.; Thomas Gonyon, B.Se; john Peter Hammond;
jones, Ph.D.; jeremy Kunkel, Ph.D.; HUIJuan lI, Ph.D.; Stephen. Hussey; Chris jones, Ph.D.; jonathan Kingsbury,
Kenneth Miller, Ph.D.; Anthony Mire-Sluis, Ph.D.; Ph.D .; Richard Meury, B.Se; Helmut Rocks troh, Ph.D.;
Anthony A.G. Ridgway, Ph.D.; Wendy Saffell.Clemmer, Jack Saad, B.Se; William F. Weiss, Ph.D.; Eloise Welfare,
M.S.; Martin Vanderlaan, Ph.D.; Ten..ihide Yamaguchi, Ph.D.; Earl Zablackis, Ph.D.
Ph.D.; Earl Zablackis, Ph.D.
 www.dl-book.ir
USP 42 People I Committees xiii

Chem ometrlcs Expert Pane l-CONCLUDED Templeton, Ph.D.; Eloise Welfare, Ph.D.; Dale Wu rster,
PEl CHEN, PH.D., AND NUNO MATOS, Co·Chairs Ph.D.; Bing·Shiou Yang, Ph.D.; Geoff Zhang, Ph.D.
Chunsheng Cai, Ph.D.; Robert Tom Cambron, Ph.D.; Peter
de B. Harrington, Ph.D.; Mark J. Henson, Ph.D.; Yang Impurities In Drug Substance and Drug Products
(Angela) Liu, Ph.D.; Zhenqi (Pete) Shi, f'h.D.; Yvan CD. Expert Panel
Vanaer Heyden, Ph.D.; Stanislav O. Zakharkin, Ph.D.; Un PRABU NAMBIAR, PH.D., M.B.A., Chair
Zhang, Ph.D. Shaukat Ali, Ph.D.; Steven w. Ba.ertschi, Ph.D.; Judy P..
Boehlert, Ph.D.; Robert G. BUice, Ph.D.; Greg J. DaVies;
Eleme ntal Impurities Expert Pane l Xi~orong He, Ph.D., M.B.A.; Kim C. Huynh.Ba, M.S.;
NANCY LEWEN, 8.SC., Choir M!chaell<oberda, Ph.D.; Robert E. Osterberg, R.Ph.,
Charles Barton, Ph.D., DABT; Courtney M. Callis, M.P.H., Ph.D., Fellow·ATS; Ernest Parente, Ph.D.; Oscar
DABT; Steven J. Dentali, Ph.D.; Anna M. Fan, Ph.D., Quattrocchi, M.Se; David H. Rogers, Ph.D.; Mark
DABT; Edward James Fletcher; Bruce A. Fowler, Ph.D., Schweitzer, Ph.D.; Mary W. Seibel; Rostyslaw O.
A.T.S.; Roland Frotschl; Assad J. Kazeminy, Ph.D.; Richard Siabicky, B.Se; Teri C. Soli, Ph.D.; Kevin A. Swiss, Ph.D.
Ko, Pharm.D., Ph.D.;Timothy L. Shelbourn, M.B.A., M.S.
General Chapters-Dosa,e f o rms
Good Docume ntation Practices Expert Panel-- JAMES E. DE MUTH, PH.D., ChOIr
CONCLUDED Emmanuel Akala, Ph.D.; Itgaz Akseli, Ph.D.; Scott Aldrich;
KIM C. HUYNH·8A, M.S., Chair Susan Cady, M.S.; Paul Curry, Ph.D.; Mario Gonzalez,
Kathleen V. Brady, B.S.; Frank J. Diana, Ph.D.; lisa Ann Fink, Ph.D.; Vivian A. Gray, B.S.; Ralph Heasley, Ph.D.;
M.B.A.; Craig Hamilton, Ph.D.; Judy Lin, M.S.; Anjan K. Anthony Hickey, Ph.D.; Michael Houghton; Munir A.
Mittal, M.Pharm.; Kevin A. Swiss, Ph.D. Hussain, Ph.D.; johannes Kramer, Ph.D.; Stefan leiner,
Ph.D.; John Mauger, Ph.D.; Colin Minchom, Ph.D.;
Modernization of Identlflc:atlon Tests Expert Panel Jolyon Mitchell, Ph.D.; Pierre·Alain Mulle r, Ph.D.; Guirag
NANCY LEWEN, B.SC., Chair Poochikian, Ph.D.; Chetan Pujara, Ph.D.; Shobhan
Anthony C. Bevilacqua, Ph.D.; Geoffrey P.R. Carr, Ph.D.; Pei Sabnis, Ph.D.; John Shabushnig, Ph.D.; Raymond D.
Chen, Ph.D.; Jonathan W. DeVries, Ph.D.; Maryna Skwierczynski, Ph.D.; Jason Suggett, Ph.D., M.B.A.;
Dmitriieva, Ph.D.; Michael Hornig, Ph.D.; Bernard A. Monica Tejwani, Ph.D.; Thomas Tice, Ph.D.; Kevin
Olsen, Ph.D.; Jeffrey S. Rohrer, Ph.D. Warner, Ph.D.; Mehran Yazdanian, Ph.D.
(467) Residual Solvents Expert Panel (771 ) Ophthalmic Preparation Expert Panel
OSCAR A. QUATTROCCHI, M.SC., Chair ASHIM K. MITRA, PH.D., Chair
Coleman C. Chasteen, M.S.; John Connelly, Ph.D.; jeffrey Dale S. Aldrich, Ph.D.;. Martin Coffey, Ph.D.; Paul Curry,
Fleitman, Ph.D.; John V. Hinshaw, Ph.D.; Bruce P. Ph .D.; Jeffrey S. Fleltman, Ph. D.; John Mauger, Ph.D.;
Johnson, Ph.D.; Eric C. Kesslen, Ph.D.; Brent Kleintop, Seshadri Neervannan, Ph.D.; Stacey M. Platzer; Chetan
Ph.D.; Elizabeth Kovacs; Paul W. Lockwood, M.S.; Pujara, Ph.D.; Satis~ K. Singh, Ph.D.; Monica Tejwani,
Gregory P. Martin, M.S.; Kevin A. Swiss, Ph.D.; Yuwen Ph.D.; Thomas R. Tlce, Ph.D.
Wang, Ph.D.
(788) Particulate Matter In Injections Expert Pane l
Quality St andards for Pharmaceutical Continuous DALE S. ALDRICH, PH.D., Chair
Manufacturing Expert Panel Dan Berdovich; Mary lee Ciolkowski, Ph.D.; Kevin Dahl,
NUNO MATOS, 8.SC., Chair Ph.D.; linda Narhi, Ph.D.; KentA. Peterson; Dean Ripple,
Shaukat Ali, Ph.D.; Ahmad Almaya; Brian Carlin, Ph.D.; Ph.D.
Thomas Garcia, Ph.D.; Douglas Hausner, Ph.D.; Eric
Jayjock, Ph.D.; Keith Jensen, Ph.D.; Johannes Khinast; Uquld· fllled Capsules Expert Panel
Pramod Kotwa l, Ph.D.; Ma rcus Krumme, Ph.D.; Kim VIVIAN A. GRAY, B.S., Chair
lamey, Ph.D.; Fernando Muzzio, Ph.D.; William joe Fotso, Ph .D.; Muni r A. Hussain, Ph.D.; Stephen C.
Randolph, Ph.D.; Mark Schweitzer, Ph.D.; Raymond TIndal; Madhusudan Vudathala, M.Pharm., M.B.A.
Skwierczynski, Ph.D.; Kelly Swinney, Ph.D.; Bernhardt
Tout, Ph.D.; Amy Walia, M.A. Performance Test for Semisolid Dosage forms
Expert Panel
Validation and Verification Expert Panel KAlLAS THAKKER, PH.D., Chair
GREGORY P. MARTIN, M.S., Chair Bryan Crist; James E. De Muth, Ph.D.; Geoffrey N. Grove,
Kimber L. Barnett, Ph.D.; C~ris topher Burgess, Ph.D.; Paul Ph.D.; l. Thomas Hall, Ph.D.; John S. Heaney; Patricia l.
D. Curry, Ph.D.; Gyongyl S. Gratzl, Ph.D.; john P. Lee, M.S.; Patrick C. Mahn; William M. Rosenthal; Steve
Hammond, FRSC; Elizabeth Kovacs; David J. LeBlond, W. Shaw
Ph.D.; Rosario loBrutto, Ph.D.; Pauline L. McGregor,
Ph.!?; Phil Nethercote, Ph.D.; Allen C. ~ertlpleton, Ph.D.; Solubility Criteria for Veterinary Drugs Expert
DaVid P. Thomas, Ph.D.; M.L. Jane Weitzel Panel
SUSAN CADY M.S., Chair
Water fo r Analytical and Pharmaceutical Purposes Bryan Crist; Mario A. Gonzalez, Ph.D.; Mark G. Papich,
Expert Panel M.S., D.V.M.; Alan F. Parr, Pharm.D., Ph.D.; Monica
TERI C. SOU, PH.D., Chair Tejwani, Ph.D.
Anthony C. Bevilacqua, Ph.D.; Lucia Clontz, D.H.Se, M.Se;
Max S. lazar; Nancy lewen, B.Se; Bruno Rossi, M.S.; Sutures Expert Panel
Rostyslaw O. Siabicky, B.Se JAMES E. DE MUTH, PH.D., Chair
Edwin Anderson, M.S.; John C. Chen; Frank Corniello;
General Chapters--Phyllcal Analysis Nomi Steen
XIAORONG HE, PH.D., Chair
Shaukat.Ali, Ph.D.; Lawrence H. Block, Ph.D.; Geoff Carr, Use of Enzymes In the Dissolution Testing of Gelatin
Ph.D.; Martin Coffey, Ph.D.; Tim Freeman; David j. Capsules Expert Panel
Goldfarb, Ph.D.; Bruno Hancock, Ph.D.; Stephen Haag, VIVIAN A. GRAY, B.S., Choir
Ph.D.; Mario Hubert, Ph.D.; Richard Meury; Matthew Ewa~ Cole, Ph.D.; l~i9i Ghidorsi; Jian. H w~ Gu~, Ph.D.;
Mullarney, M.S.; Prabu Nambiar, Ph.D.; Myke Scoggins, Felxue Han, Ph.D., Jian· Hwa Han, Ph.D., Christopher T.
Ph.D.; Changquan Sun, Ph.D.; Zhigang Sun, Ph.D.; Allen Hasty; Johannes Kramer, Ph.D.; Thomas langdon;
Steven R. Leinbach; Stefan Leiner, Ph.D.; Gregory P.
 www.dl-book.ir
xiv Committees I People USP 42

Martin, M.S.; Steven M. Meyerhoffer, Ph.D.; Richard C. Janssen, Ph.D.; Douglas E. Kiehl, M.Sc.; Wendy Mach,
Moreton, Ph.D.; Edward Shneyvas, Ph.D.; Jason A. B.Sc; Robert Przygoda; Anita Y. Sawyer, M .S.; Cheryl
Suggett, Ph.D.; Stephen C. TIndal; Madhusudan Stults, Ph.D.
Vuaathala, M.Pharm., M.B.A.; Hu Wang, M.S.
. Clinical Trial Materials (GDP) Expert Panel-
Vbual Inspection of Parenterals Expert Panel CONCLUDED
RUSSELL E. MADSfN, M.S., Chair MARY G. FOSTER, PHARM.D., BFA, Choir
Dale S. Aldrich, Ph.D.; John D. Ayres, M.D., J.D.; Roy Christopher Anderson, M.A.; Rafik H. Bishara, Ph.D.;
Cherris; John G. Shabushnig, Ph.D.; Deborah Shnek, Glaucia K. Braga, Ph.D.; .Jeffr~y Carrico, Pharm.D.; ~teven
Ph.D. A. Jacobs, M.B.A.; Martin jelven, M.S.; Claude Jolicoeur,
B.S.; Gao Yonghua, B.S. Pharm.
General Chapters-Microbiology
DAVID HUSSONG, PH.O., Choir (661 .3) Plastic: Systems Used for Manufacturing
James Agal1oco, M.S.; James Akers, Ph.D;; Dili'p Ash tekar, Phannac:eutlc:al Products Expert Panel
Ph.D.; Anthony Cundell, Ph.D.; DenniS Guilfoyle, Ph.D.; DENNIS R. JENKE, PH.D., Chair
Rajesh Gupta, Ph.D.; Russell Madsen, M.S.; Karen Weibing Ding, Ph.D.; Michael N. Eakins, Ph.D.; Mary C.
MCCullough, M.S.; Robert Mello, Ph.D.; David Roesti, Foster, Pharm.D., BFA; james Hathcock, Ph.D.; Jerold
Ph.D.; Donald Singer, M .S.; Paul Stinavage, Ph.D.; Oerry) M. Martin, M.S.; Diane M. Paskiet, M.S.; Robert
Edward Tidswell, Ph.D. Steininger; Cheryll.M . Stults, Ph.D.; Ken M. Wong,
M.Sc
Modem Microbiological Methods Expert Panel
ANTHONY CUNOElt, PH.D., AND EDWARD TIDSWELL, PH.D., Co- (662) Metal Pac:kagln~ Components and Systems
Chairs CHERYL STULTS, PH.D., ChaIr
Thierry Bonnevay, Ph.D.; Ralph Breton, B.S. Pharm.; Pe ter Claessens; ~eniamin Jeyaretnam, Ph.D.; Ralph Lessor,
Claudio Denoya, Ph.D.; Gary du Moulin, Ph.D.; John Ph.D.; Sara Miller, M.S.; Caby Reckluegel; john
Duguid, B.Sc; Rajes~ Gupta, Ph.D.; David Husso~g, Willenbrock, B.Sc
Ph.D.; Matthew JenkinS, M.S.; Amy lynn McDantel,
Ph.D.; Michael Miller, Ph.D.; Felix Montero Julian, Ph.D.; General Chapters-Statistics
David Newton, Ph.D.; Kuldip Patel; Steven Rich ter, ROBERT R. SINGER, M.S., Chair
Ph.D.; David Roesti, Ph.D.; Yongqiang Zhang, Ph.D.; Bruno Boulanger, Ph.D.; Richard Burdick, Ph.D.; David
Steve S. Zigler, Ph.D. Christopher, M.S.; David Lansky, Ph.D.; Dave LeBlond,
Ph.D.; Juris Meija, Ph.D.; An thony Okinczyc, M.P.H.;
General Chapters--Packaglng and Dbtributlon Peter Rigsby, M.S.; Dennis Sandell, Ph.D.; Timothy
MARY G. FOS-HR, PHARM.D., 8FA, Chair Schofield, M.A.; Charles Tan, Ph.D.; Edwin van den
Chris Anderson, M.A.; Bettine Boltres, Ph.D.; Glaucia Braga, Heuvel, Ph.D.; Jane Weitzel; Harry Yang, Ph.D.
Ph.D.; Riekert Bruinink; .Jeffrey Carric,o, Pharm.D.; Chris
Chandler, Pharm.D.; Michael N. Eakins, Ph.D.; Dana Content Unlfonnlty with Large Sample Sizes
Guazzo, Ph.D.; Renaud Janssen, Ph.D.; Dennis Jenke, Expert Panel
Ph.D.; Wendy Mach, B.Sc; Dan Malinowski; Daniel DENNIS SANDEll, PH.D., Chair
Norwood, Ph.D.; Diane Paskiet, M.S.; Robert Seevers, IIgaz Akseli, Ph.D.; james S. Bergum, Ph.D.; Paul Curry,
Ph.D.; Cheryl Stults, Ph.D.; Li Xiong, Ph.D.; Gao Ph.D.; Walter Hauck, Ph.D.; Jeffrey Hofer, M.S.; Gregory
Yonghua, B.S.Pharm. l. Larner, M.S.; Raymond Skwierczynski, Ph.D.

(381 ) Elastomeric Closure for Injections Expert

Panel Expert Committees for the Natlontll
DIANE M. PASKIET, M.S., AND RENAUD JANSSEN, PH.D., Co-Chairs
Douglas J. Ball, M.S., DABT; Michael N. Eakins, Ph.D.; Dana Formulary
Guazzo, Ph.D.; Dennis R. Jenke, Ph.D.; Douglas Kiehl,
M.S., B.S.; Heinz Kirchmeyer, Ph.D.; Philippe LeGan, Exdplents Monographs 1
M .S.; Daniel l. Norwood, Ph.D.; Michael A. Ruberto, ERIC MUNSON, PH.D., Choir
Ph.D.; lisa M. Yoest, M.S. Thiago Carvalho, Ph.D.; Brian Carlin, Ph.D.; Richard
Cawthorne, Ph.D.; Richard Creekmore, Ph.D.; Vivek
(659) Packaging and Storage Requirements Expert Dave, Ph.D.; Felicitas Guth; Otilia Koo, Ph.D.; Phil
Panel-CONtlUDED Merrell, Ph.D.; Dominic Moore; Chris Moreton, Ph.D.;
CHRIS CHANDLER, PHARM.D., Choir Jasmine Musakhanian, M.S.; Charles Vesey, M.S.;
Glaucia Braga, B.Sc; Jeffrer. Carrico, Pharm.D.; Mary G. Richard Wendt, Ph.D.; ]in Zhao, Ph.D.
Foster, Pnarm.D. BFA; E eanor Freeman, B.S.; Wendy
Mach, B.Sc; Devinder Pal, M .Pharm.; R~bert H. Seevers, (1059) Cha pter Excipient Performance Expert
Ph.D.; Gao Yonghua, B.S. Pharm; li Xiong, Ph.D. Panel
(660) Contalners-Glau Expert Panel GREGORY AMIDON, PH.D., AND RICHARO MORETON, PH.D.,
BETTINE BOLTRES, PH.D., AND MICHAEL EAKINS, PH.D., Co-Chairs
Co-Choirs
Michael E. Akers, B.A.; Alberto Biavati, Ph.D.; Juan Cerdan- IIgaz Akseli; Shaukat Ali, Ph.D.; Lawrence Block, Ph.D.;
Diaz; Carol Rea Flynn, M.S.; Emanuel Guadagnino, M.D.; Thiago Cardoso Carvalho, Ph.D.; Brian Carl in, Ph.D.;
Daniel Edward Haines, Ph.D.; Kevin McLean, B.Sc; Kelly Richard Creekmore, Ph.D.; Stephen Hoag, Ph.D.;
Murphy, Ph.D.; Volker Rekowski; Jennifer Martell Roark, Johannes Khinast; Jasmine Musakhanian, M.S.;
B.Sc.; Holger Roehl, Ph.D.; Gao Yonghua, B.S. Pharm. Natarajan Rajagopalan, Ph.D.; Hiroko Shibata, Ph.D.;
Jiasheng Tu, Ph.D.; Katherine Ulman, B.Sc; Maureen
Blocompatlblllty of Materials Used In Packaging Taylor Vander Fliet, M.S.; John Wang, Ph.D.
Systems, Medical Devices, a nd Implants Expert
. Panel (1059) Exclclent Performanc:e Expert Panel-
DANIEL l. NORWOOD, PH.D., Chair CONCLUDE
Douglas J. Ball, M.S.; Stephen A Barat, Ph.D.; William P. ERIC A. SCHMITT, PH.D., Choir
Beierschmitt, Ph .D.; Daniel Berdovich; Denise Bohrer, Abdullah M. AI-Mohizea, Ph.D.; Shaukat Ali, Ph.D.;
Ph.D.; Tage e.G. Carlson, Ph.D.; Michaci N. Eakins, Lawrence H. Block, Ph.D.; Patrick Deluca, Ph.D.; Carl
Ph.D.; Jill A Glosson, B.A.; John Iannone, B.Sc; Renaud Frey, M.S.; Xiaorong He, Ph.D., M.B.A.; Stephen W.
 www.dl-book.ir
USP 42 People I Committees xv

Haag, Ph.D.; Michelle A. lon9, Ph.D.; Richard C. Victor Navarro, M.D.; Mary Paine, Ph .D.; Pradyumna
Moreton, Ph.D.; Prabu Namblar, Ph.D., M.B.A.; James Theertham Rao, Ph.D.; Cynthia Rider, Ph.D.
A Ponto, M.S.; Kent Sternitzke, Ph.D.; Kevin A. Swiss,
Ph.D.; Sean V. Taylor, Ph.D. Herbal Medicines Compendium (HMC) Ea st Asia
Expert Panel
(1197) Good Distribution Practices for Bulk DE-AN GUO, PH.D., Choir
Pha rma ceutica l Exclple nt s Expert Pane l- Yuan-shiun Chang, Ph.D.; Shil.i n Chen, Ph.D.; T~kas~i
CONCLUDED Hakamatsuka, Ph.D.; Shen JI, Ph.D.; Yeong Shlk Kim,
RICHARD C. MORETON, PH.D., Chair P~.D.; .Hwee-lin':3 Koh! Ph.D.; Clara Bik San lau, Ph.D;
lawrence H. Block, Ph.D.; William Dale Carter, M.S.; Zak Ping lI, Ph.D.; Qmg ll, Ph .D.; Shuangcheng Ma,
T. Chowhan, Ph.D.; Marc Fages; El izabet~ Ferguson. Ph.D.; Shangme! Shi; Viet Hung Tran, Ph.D.; Pengfei
Brown; Mary G. Foster, Pharm.D., BFA; linda A. Tu, Ph.D.; Wanylng Wu, Ph.D.; Zhongzhen Zhao,
Herzog, M.B.A.; Ashok V. Katdare, Ph.D.; Zakiya Ph.D.
Kurdi, Ph.D.; Edward G. Malawer, Ph.D., CQA; Frank
Milek, Ph.D.; Becc.:a Mitchell; Dwight Mutchler; Herbal Medicines Compendium (HMC) So uth
Garnet E. Peck, Ph.D.; Mike Schultz, R.Ph.; Alexa Asia Expert Panel
Smith, M.S.; Glenn Sokoloski; Kelly Taylor; Jiasheng SUKHOEV S. HANDA, PH.D., FNAIM, FNA.SC, Chair
Tu, Ph.D. AmitA.9arwal, Ph.D.; Rasadah Mat Ali, Ph.D.; Mohamed
Zahrr Mohammed Farhad; C.K. Katiyar, Ph.D.;
Exclplents Monogra phs 2 Bhawanishankar Madhira, Ph.D.; Ami Fazlin Syed
MARY C. HOUCK, PH.D., Chair Mohamed, Ph.D.; A. Nagarajan, Ph.D.; D.G . Naik,
lawrence H. Block, Ph.D.; Andrew Bluj; Tim Cabelka, Ph.D.; Ph.D.; Sankaran Natarajan, Ph.D.; M. K. Raina, Ph.D.;
Arya Jayatilaka, Ph.D.; Russell Maus, Ph.D.; Robert E. J.l. N. Sastry, Ph.D.; Rajeev Kr. Sharma, Ph.D.; R.
Osterber9, R.Ph., Ph.D., Fellow-ATS; Julie Warner Pier, Sundaram, Ph.D.; Neeraj Tandon, Ph.D.; Surapote
M.S.; Amsul Quadir, Ph.D.; Gwen Rucker; Barbara Serr, Wongyai, Ph .D.
Ph.D.; Huimin Sun, Ph.D.; Jiasheng Tu, Ph.D.; Jacqueline
Tordik; Fan Wu, Ph.D.; Timothy Yasika Dietary Supplements Safety Modellng-
CONCLUDED
Glycerin Expert Panel MARY L. HARDY, M.D., Chair
TIM B. CABELKA, PH.D., Chair V.A. Shiva Ayyadurai, Ph.D.; Mary A. Fox, Ph .D., M.P.H.;
Frances K. Byrne, M.S.; Ian A. Duncan, Ph.D.; Tant" Scott A. Jordan, Ph.D.; Mkaya Mwamburi, M.D., Ph.D.,
Natterer; Marian j. Rinken, Ph.D.; Gwen E. Ruc er, MA (Econ); Diane R. Mould, Ph.D.; Robert E. Osterberg,
B.S.; David A. Sharknas, B.S.; Hong Zhou, Ph.D. R.Ph., Ph.D., Fellow-ATS; Charlie Yoe, Ph.D.
Povldones Expert Pa nel-CONCLUDED Canna bis Expert Pa nel
BERNHARD D. FUSSNEGGER, PH.D., AND CARL PERINI, M.S., Co- IKHlAS A. KHAN, PH.D., Chair
Chairs Paula N. Brown, Ph.D.; lawre.nce Deyton, ~.p.; Mahmoud
Feng Chen, Ph.D.; David J. Fillar, M.B.A.; Edward G. A. Elsohly, Ph.D.; Sytze ElZinga, M.S.; Philippe Henry,
Malawer, Ph.D.; SyedAA. Rizvi, Ph.D.; John W. Spink, Ph.D.; Christopher Hudalla, Ph.D.; Holly Johnson, Ph.D.;
Ph.D.; Fan Wu, Ph.D. Robin Maries, Ph.D.; Jeremy Melanson, Ph.D.; Roy
Upton; Gordon Vrdoljak, Ph.D.; Joshua Wurzer, B.Sc.
Talc Methods Expert Pa nel
IUlIE WARNER PIER, M.S., AND MARTIN RUTSTEIN, PH.D., Co- Non-Bota nical Dieta ry Supplements
Chairs DENNIS K.I. GORECki, 8.S.P., PH.D., Chair
Daniel Crane; Sean M. Fitzgerald, B.Sc.; Mickey E. Joseph Betz, Ph.D.; Michael Bradley, M.S.; James Brooks,
Gunter, Ph.D.; Don Halterman, M.S.; Mary C. Houck, Ph.D.; B~II Gurl~y, Ph.D.; Chung Hyun, M.S.; Joy Joseph,
Ph.D.; lee Poye, B.Sc.; Matthew S. Sanchez, Ph.D.; M.S.; Ralmar lobenberg, Ph.D.; Richard Myers, Ph.D.;
Alan M. Segrave, B.Sc.; Gary P. Tomanino, B.Sc.; James Neal-Kababick, B.Sc.; Peter Rice, Pharm.D., Ph.D.;
Drew R. Van Ordern, M.A.; James Webber, Ph.D. Amy Roe, Ph.D.; ~niko Solyom, Ph.D.; Karunakar Sukuru,
Ph.D.; Darryl Sullivan, Ph.D.

Expert Committees for the USP and (225 1) Adulteration of Die t a ry Supplements with
Drugs and Drug Ana Jogs Expert Panel
the Dietary Supplements Compendium DENNIS K. I. GORECKI, B.S.P., PH.D., Chair
joseph~. Betz, Ph.D.; Pei Che~, Ph.D.; Hwee.linQ Koh,
Ph.D., Ikhlas A. Khan, Ph.D., James Neal-Kababrck,
Botanical Dietary Supple ments and Herbal B.Sc.; John Spink, Ph.D.; Darryl Sullivan, Ph.D.
Medicines
ROBIN J. MARlES, PH.D., Chair Extended-Release Dietary Supplements Expert
Thomas Brendler, B.A.; josef A. Brinckmann; Paula Naomi Panel-CONCLUDED
Brown, Ph.D.; Angela Calderon, Ph.D.; Steven Dentali, JOY A. JOSEPH, M.S., Chair
Ph.D.; Edward Fletcher, B.A.; Stefan Gafner, Ph.D.; Joerg Charles Barton, Ph .D., DABT; Joseph F. Borzelleca, Ph.D.;
Gruenwald, Ph.D.; De-an Guo, Ph.D.; Sukhdev Swami Michael S. Bradley, M.S.; James R. Brooks, Ph.D.;
Handa, M.Pharm., Ph.D';James Harnly, Ph.D.; Craig Marion Ehrich, Ph.D.; V~vian A:. Gray, B.S.; Carol
H.opp, Ph.D.; Scott A. Jar an, Ph.D.; Ikhlas Khan, PliO.; johnston, Ph.D., RD; Ralmar lobenber9, Ph.D.;
Richard Ko, Pharm.D., Ph.D.; TIeraona low Dog, M.D.; Alexander G. Schauss, Ph.D., FACN; Elizabeth A
Mirtha Navarro, Ph.D.; Pilar Pais, Ph.D.; Guido Pauli, Yetley, Ph.D.
Pharm.D., Ph.D.; Eike Reich, Ph.D.; Paul Schiff, Ph .D.;
Shangm ei Shi, B.Sc. Problotlcs Expert Pa nel
MARY ELLEN SANDERS, Chair
. Green Tea Extract Hepa totoxicity Expert Pane l Mike Bradley, M.S.; Marie-Eve Boyte; James Brooks,
RICHARD KO, PHARM.D., AND AMY LYNNE ROE, PH.D., Co- Ph.D.; Pierre Burguiere, Ph.D.; Scott Jackson, Ph.D.;
Chairs David Keller; Marco Pane, M.S.; Amy Roe, Ph.D.; Jean
Joseph M. Betz, Ph.D.; Bill Gurley, Ph.D.; Kan He, Ph.D.; Schoeni, Ph.D.; Bufty Stahl, B.Sc.; Christina Skovgaard
Scott Jordan, Ph.D.; Mahendra P. Kapoor, Ph.D., Vegge, Ph.D.
Tieraona low Dog, M.D.; Robin James Maries, Ph.D.;