The Pharmacopeia

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What’s the meaning of Pharmacopeia?

• It is compound created from two Greek words:

pharmakon (drug) and poiein (to make).

• The goal of pharmacopeia is publishing and

producing quality standards for pharmaceuticals

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The most used pharmacopoeias:
• United States Pharmacopeia (USP)

• United States Pharmacopeia & National formulary

(USP-NF)

• European Pharmacopoeia (EP)

• British Pharmacopoeia (BP)

• Japanese Pharmacopoeia (JP)

• Chinese Pharmacopoeia (ChP)

• Egyptian Pharmacopeia (EP 1984) 3

• United States Pharmacopeia
& National formulary 2008
(USP 31-NF 26)

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USP-NF:
A book of public pharmacopeial standards for
chemical and biological drug substances,
dosage forms, compounded preparations,
excipients, medical devices, and dietary
supplements.
Mission of USP-NF:
To improve the health of people around the
world through authoritative standards and
related programs that help ensure the quality,
safety, and benefit of medicines and foods.
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• USP–NF is a combination of two compendia,
the United States Pharmacopeia (USP) and the
National Formulary (NF).
• The United States Pharmacopeia (USP)
includes; Monographs for drug substances,
dosage forms, and compounded preparations.
The monographs for dietary supplements appear
in a separate section in USP .
• The National Formulary (NF) includes;
Monographs for excipient.

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 History:
• 1820: A group of physicians published a
pharmacopeia of the best therapeutic products and
contained recipes for the preparation of 217 drugs.
• 1888: American pharmaceutical association
published NF.
• Since 1975: USP & NF have been published
together.
• Since 2002: USP has been published annually.

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 How is USP 31-NF 26 organised?

Volume 1 Volume 2 Volume 3

• Front matter• USP monographs • USP monographs

• General chapters
from A-L from M-Z
• Dietary supplement monographs
• NF monographs

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 Contents of USP-NF 2008:

• Volume 1
1. Mission statement and preface
2. People & USP governance
3. General notices and requirements
4. General chapters
5. Reference tables
6. Monographs of dietary supplement
7. NF ( monographs of excipients)
8. Combined index to USP 31& NF 26

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• Volume 2
1. Guide to general chapters
2. General notices and requirements
3. Monographs for drugs (A-L)
4. Combined index to USP 31& NF 26
• Volume 3
1. Guide to general chapters
2. General notices and requirements
3. Monographs for drugs (M-Z)
4. Combined index to USP 31& NF 26

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 How is USP 31-NF 26 organised?
General Chapters:
• General tests and assays.
• Reagents, indicators and solutions.
• Reference tables e.g. table of atomic masses.

• General chapters are present only in volume

1 and other volumes contains a guide to
general chapters.

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 General chapters:

Each general chapter is assigned a number that appears

in brackets adjacent to the chapter name e.g.
chromatography <621>
The use of general chapter numbers is encouraged for
identification of and rapid access to general tests and
information.

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Example:
Vol. II

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 How is USP 31-NF 26 organised?
Monographs:
Alphabetically arranged
1) Name of the drug/ substance
2) Structure, molecular formula, molecular weight,
nomenclature
3) Limits of content, definition
4) Identification tests, impurities, tests
5) Assay
6) Packaging and storage 15
Generic name of the drug

Structure
Molecular formula & molecular mass
Nomenclature

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General Notices &
Requirements

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The General Notices and Requirements:

1) Provide the basic guidelines for the interpretation of

the standards, including (Definitions, abbreviations and
general notes about tests and assays).

2) Exist in the front of each volume to eliminate the need

to repeat requirements for each drug monograph.

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  Official
The word "official“ used in the Pharmacopeia is synonymous
with "Pharmacopeial,", and with "compendial."
= comply with pharmacopoeial standards

 Official Substance
Is an active drug entity, a dietary supplement or a
pharmaceutical ingredient for which the monograph title
includes with no indication of the nature of the finished
form. e.g. Aspirin
 Official Preparation
It is the finished preparation or product of one or more
official substances. e.g. Aspirin tablet 19
 Abbreviations
VS : Volumetric Solution (with standardization)
e.g. 0.1 M NaOH

TS : Test Solution (no standardization)

e.g. indicators

RS: Reference Standard

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USP Reference Standards (RS)

USP Reference Standards are Authentic Specimens that

are suitable for use as comparison standards in USP or
NF tests and assays.

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Abbreviations for Institutions and Organizations

Abbrev. Institution or Organization

ACS American Chemical Society.

FDA Food and Drug Administration.

IUPAC International Union of Pure and Applied

Chemistry.

WHO World Health Organization.

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 Tests and Assays:
The appropriate quantities to be taken for assays and tests,

The use of the word “About” indicates a quantity within

10% of the specified weight or volume.

Expressions such as “25.0 mL” and “25.0 mg’’, indicate

that the quantity is to be “accurately measured” or
“accurately weighed”.

The term “Transfer” is used generally to specify a

quantitative manipulation.
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The term “Concomitantly” used in such expressions
as “concomitantly determine” or “concomitantly
measured”, is intended to denote that the determinations
or measurements are to be performed in immediate
succession.

Blank Determination: The determination is to be

conducted using the same quantities of the same reagents
treated in the same manner as the solution or mixture
containing the portion of the substance under assay or
test, but with the sample itself omitted.

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• Solutions: Unless otherwise specified in the
individual monograph, all solutions called for in tests
and assays are prepared with purified water.

• Water: Water used as an ingredient of official

preparations meets the requirements for Purified
Water

• Indicators: Where the use of a test solution (TS) as

an indicator is specified in a test or an assay,
approximately 0.2 mL, or 3 drops of the solution
shall be added, unless otherwise directed.

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• Temperatures: All temperatures are expressed in
centigrade degree, and all measurements are made at
25°. Where moderate heat is specified, any
temperature not higher than 45° is indicated.

• Dilution: Where it is directed that a solution be

diluted “quantitatively and stepwise,” an accurately
measured portion is to be diluted by adding water or
other solvent.

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Solubility descriptive terms

Descriptive Term Parts of solvent for 1 part of solute

Very soluble Less than 1

Freely soluble From 1 to 10
Soluble From 10 to 30
Sparingly soluble From 30 to 100
Slightly soluble From 100 to 1000
Very slightly soluble From 1000 to 10000
Practically insoluble Greater than or equal to 10000

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 Weights and Measure

The International System of Units (SI) is used

in the USP pharmacopoeia.
kg = kilogram=103g L = liter
g = gram mL = milliliter
mg = milligram=10-3g μL = microliter
μg, mcg = microgram=10-6g mol = gram- molecular
ng = nanogram=10-9g weight (mole)
pg = picogram=10-12g Eq = gram-equivalent
Da = Dalton (relative molecular weight
mass)

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Concentrations
Molality (m): It is the number of moles of the designated
solute contained in one kilogram of the designated
solvent.
Molarity (M): It is the number of moles of the designated
solute contained in an amount of the designated solvent
that is sufficient to prepare one liter of solution.

Normality (N): It is the number of equivalents of the

designated solute contained in an amount of the
designated solvent that is sufficient to prepare one liter of
solution.

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Percentage concentrations
Percent Weight in Weight ( %w/w):
Express the number of g of a constituent in 100 g of
solution or mixture. It’s used for mixtures of solids or
semisolids.
Percent Weight in Volume ( %w/v):
Express the number of g of constituent in 100 mL of
solution. It’s used for solutions or suspensions of solids in
liquids.
Percent Volume in Volume (%v/v):
Express the number of mL of the constituent in 100 mL of
solution. It’s used for solutions of liquids in liquids.

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 Storage Temperature
Freezer: A place in which the temperature is maintained
between -25° and -10°.

Cold: Any temperature not exceeding 8°. A refrigerator is

a cold place in which the temperature is maintained
between 2° and 8°.

Cool: Any temperature between 8° and 15°.

Warm: Any temperature between 30° and 40°.

Excessive heat: Any temperature above 40°.

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If you are asked to analyse an aspirin sample,
How will you start your work?

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?

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Last Edition of United States Pharmacopeia
& National formulary was published on
May 1, 2024 (USP 47-NF 42)

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