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Certificate of Analysis Certified Reference Material Certipur Buffer Solution PH 4.00 (20°C)

The document is a Certificate of Analysis for Certipur® Buffer solution pH 4.00, which is a certified reference material for pH measurement with an expiry date of 2024/02/29. It details the product's composition, certified pH value of 4.01 ± 0.02, and metrological traceability to primary certified reference materials. The certificate also includes handling instructions, associated uncertainties, and accreditation information for the producer, Merck KGaA.

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0% found this document useful (0 votes)
22 views2 pages

Certificate of Analysis Certified Reference Material Certipur Buffer Solution PH 4.00 (20°C)

The document is a Certificate of Analysis for Certipur® Buffer solution pH 4.00, which is a certified reference material for pH measurement with an expiry date of 2024/02/29. It details the product's composition, certified pH value of 4.01 ± 0.02, and metrological traceability to primary certified reference materials. The certificate also includes handling instructions, associated uncertainties, and accreditation information for the producer, Merck KGaA.

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Certificate of Analysis – Certified Reference Material

Certipur® Buffer solution pH 4.00 (20°C)


Certified Reference Material for pH measurement

Product no.: 1.09435.1000


Lot no.: HC15176435
Description of CRM: Certipur® Buffer solution pH 4.00 (20°C)
Certified Reference Material for pH m easurement
Expiry date: 2024/02/29
Storage: +15°C to +25°C tightly closed in the original container
Composition: citric acid / sodium hydroxide / hydrogen chloride

Associated uncertainty, U=k .u


Certified value
(k=2)

pH value 4.01 ± 0.02 (20°C)

Metrological traceability: The pH value of this certified buffer solution is directly traceable to prim ary
certified reference m aterials characterised by PTB and verified by SRMs from
NIST.
NIST 189c, 188, 185i, 186 Ig, 186 IIg, 187f
PTB OX-405/18, TA-442/19, PHT-467/20, PHO-490/20, BO-468/20
PTB: Physikalisch Technische Bundesanstalt, Braunschweig, Germany
NIST: National Institute of Standards and Technology, Gaithersburg, USA.
Measurement method: pH value is m easured with a com bined glass electrode after 5-point calibration
according to DIN 19268 with reference buffer solutions according to DIN
19266, IUPAC, NIST, Ph.Eur. and USP.

Accreditation: Merck KGaA, Darm stadt, Germ any is accredited by the Germ an accreditation
authority DAkkS as registered reference m aterial producer D-RM-15185-01-00
in accordance with ISO 17034.

Certificate issue date: 2021/02/10

CRM released by Approving Officer


or delegate LS-OII-QS3

ISO 17034
Dipl.-Ing. Ayfer Yildirim
Responsible Manager of LS-OII-QS3
(Accredited Calibration Laboratory)

Merck KGaA, 64271 Darmstadt, Germany, Tel.: +49 (0)6151 72-24 40


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


Intended use: This reference m aterial is intended for use as a calibration standard for pH
instrum ents or pH electrodes or as a control sam ple for m easuring the pH value.
Instructions for handling The pH value is strongly dependent on the temperature. It is therefore necessary
and correct use: to keep the tem perature constant within the m easurement.
Health and safety Please refer to the Safety Data Sheet for detailed inform ation about the nature of
information: any hazard and appropriate precautions to be taken.
Preparation: This reference m aterial is prepared gravim etrically from citric acid, sodium
hydroxide, hydrogen chloride and high purity water.

Associated uncertainty:
The expanded uncertainty UCRM is calculated as UCRM = k·u CRM, where k = 2 is the coverage factor for a 95%
coverage probability and u CRM is the com bined standard uncertainty in accordance to ISO 17034.
The com bined uncertainty u CRM is derived from combination of the squared uncertainty contributions:

𝑢𝐶𝑅𝑀 = √𝑢 2𝐶ℎ𝑎𝑟𝑎𝑐𝑡𝑒𝑟𝑖𝑠𝑎𝑡𝑖𝑜𝑛 + 𝑢 2𝐻𝑜𝑚𝑜𝑔𝑒𝑛𝑒𝑖𝑡𝑦 + 𝑢 2𝑆𝑡𝑎𝑏𝑖𝑙𝑖𝑡𝑦

u characterisation : is the uncertainty in accordance with DIN EN ISO/IEC 17025 which includes the
contributions of the prim ary reference m aterial and the m easuring system. The
characterisation measurements have been conducted by our DAkkS accredited
calibration laboratory (D-K-15185-01).
u homogeneity: is the between-bottle variation in accordance with ISO 17034. The assessment
of hom ogeneity is perform ed by analysis of a representative num ber of
systematically chosen sample units.
u stability: 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 reference m aterial for the unopened bottle .

Informative values:
Tem perature dependence 1: Tem perature [°C] ∆ pH
0 + 0.05
5 + 0.04
10 + 0.02
15 + 0.01
20 ±0
25 + 0.01
30 + 0.01
35 + 0.01
40 + 0.01
50 ±0

1
Tem perature deviation data provided for reference only. Values are not batch -specific and should not be considered
certified values.

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

Certificate of analysis revision history:


Certificate version Date Reason for version
01 2021/02/10 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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