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Certificate of Analysis - Certified Reference Material: Certipur Tris (Hydroxymethyl) - Aminomethane

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96 views2 pages

Certificate of Analysis - Certified Reference Material: Certipur Tris (Hydroxymethyl) - Aminomethane

Uploaded by

AndresOchoa
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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Certificate of Analysis – Certified Reference Material

Certipur® Tris(hydroxymethyl)-aminomethane

Product no.: 1.02408.0080


Lot no.: 202408U
Description of CRM: Tris(hydroxymethyl)-aminomethane

Expiry date: 2025/11/30


Storage: +15°C to +25°C tightly closed in the original container and protect from light and
moisture
Composition: Tris(hydroxymethyl)-aminomethane

Associated uncertainty, U=k .u


Analyte Certified value as mass fraction
(k=2) as mass fraction

Mass fraction 99.96 % ±0.09%

Metrological traceability: Directly traceable to the corresponding primary standard NIST SRM
Tris(hydroxymethyl)-aminomethane 723e.
Measurement method: The certified mass fraction was determined by potentiometric titration with
hydrochloric acid as titration solution. The certified value is based on a molecular
mass M = 121.136 g/mol dried substance.
Intended use: This volumetric standard is intended for standardisation of volumetric solutions
in accordance to the chapter reagents of the Pharmacopoeia (Ph. Eur., USP).
Instructions for handling The volumetric standard Tris(hydroxymethyl)-aminomethane must be kept 24
and correct use: hours in a desiccator above drying agent with a moisture indicator before use.
By within-unit homogeneity studies a minimum weigh-in quantity of 150mg was
determined.
Accreditation: Merck KGaA, Darmstadt, Germany is accredited by the German accreditation
authority DAkkS as registered reference material producer D-RM-15185-01-00
in accordance with ISO 17034.

Certificate issue date: February 8, 2021

CRM released by Approving Officer


or delegate LS-OII-QS3

Dipl.-Ing. Ayfer Yildirim


Responsible Manager of LS-OII-QS3
ISO 17034
(Accredited Calibration Laboratory)

Merck KGaA, 64271 Darmstadt, Germany, Tel.: +49 (0)6151 72-2440


EMD Millipore Corporation, 400 Summit Drive Burlington MA 01803, USA, Tel. +1-978-715-4321
Sigma-Aldrich Canada Co. or Millipore (Canada) Ltd., 2149 Winston Park, Dr. Oakville,
Ontario, L6H 6J8, Phone: +1 800-565-1400

Certificate Page 1 of 2 Certificate version 01


Health and safety Please refer to the Safety Data Sheet for detailed information about the nature of
information: any hazard and appropriate precautions to be taken.

Certification process details:


Certipur® Volumetric standards are prepared from high purity salts. Characterisation of Certipur® Volumetric
standards is carried out by the accredited quality control (QC) laboratory at Merck KGaA, Darmstadt, Germany
according to DIN EN ISO / IEC 17025 by measuring the mass fraction by potentiometric titration.
Homogeneity and stability studies are performed with the material according to the requirements of ISO 17034 and
ISO Guide 35.

Associated uncertainty:
The associated uncertainty UCRM reported with the certified values is calculated as combined expanded uncertainty
UCRM=k·uCRM in accordance with GUM and EA-4/02, with k=2 as the coverage factor for a 95% coverage probability.

The combined uncertainty uCRM is derived from combination of the squared uncertainty contributions:
u CRM = u 2 Characteri sation + u 2 Homogeneit y + u 2 Stability

ucharacterisation: is the uncertainty in accordance with DIN EN ISO/IEC 17025 which includes the
contributions of the primary reference material and the measuring system. The
characterisation measurements have been conducted by our DAkkS accredited
calibration laboratory (D-K-15185-01).

uhomogeneity: is the between-bottle variation in accordance with ISO 17034. The assessment
of homogeneity is performed by analysis of a representative number of
systematically chosen sample units.

ustability: is the uncertainty obtained from short-term and long-term stability in accordance
with ISO 17034. The stability studies are the basis for the quantification of the
expiry date of this volumetric standard for the unopened bottle.

For more detailed information please read the certification report on our website.

Certificate of analysis revision history:


Certificate version Date Reason for version
01 February 8, 2021 Initial version

The vibrant M, Supelco, Certipur and Sigma-Aldrich are trademarks of Merck KGaA, Darmstadt, Germany or its affiliates.
Detailed information on trademarks is available via publicly accessible resources.
© 2018 Merck KGaA, Darmstadt, Germany and/or its affiliates. All Rights Reserved.

Certificate Page 2 of 2 Certificate version 01

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