Water CoA 1880510010 - HC72729851 - SU - EN PDF

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AquastarTM Certified Reference Material

Producer: Merck KGaA, Frankfurter Str. 250, 64293 Darmstadt, Germany.

Accreditation: Merck KGaA, Darmstadt, Germany is accredited as calibration


laboratory according to DIN EN ISO/IEC 17025.

Description of CRM: Water Standard 0.1%


certified reference material for coulometric Karl Fischer Titration

Ord. No.: 1.88051.0010

Lot No.: HC72729851

Composition: 1-Methoxy-2-propanol

Certified value and uncertainty: 0.0997 % ± 0.0020 %


(0.997mg/g ± 0.020 mg/g)
water content with expanded uncertainty UCRM

Traceability: The certified value of this reference material is directly traceable to SI-
Unit (kg) and verified by NIST SRM 2890.
NIST: National Institute of Standards and Technology, Gaithersburg, USA.

Method of Analysis: The water content is determined by coulometric Karl Fischer Titration
on 10 ampoules according to ISO 760.

Storage: +15°C to +25°C tightly closed in the original container

Application and correct use: This certified reference material is intended for use as a standard for
checking the accuracy of Karl Fischer equipment according to ISO
9001 chapter 7.1.5 “Monitoring and measuring resources” of
coulometric Karl Fischer Titrators.
It can also be used to check measuring results according to European
Pharmacopeia (Ph.Eur.) chapter 2.5.32 “Water Micro Determination”.

For the daily verification we recommend to accept a deviation


of ± 0.0030 % (± 0.030 mg/g) from the certified value.

Date of release: 2017/04/27

Minimum shelf life: 2022/04/30

Dipl.-Ing. Ayfer Yildirim


(Laboratory manager)

Merck KGaA – Frankfurter Straße 250, 64293 Darmstadt, Germany: +49 6151 72-0
EMD Millipore Corp. – 290 Concord Road, Billerica, MA 01821, USA: (781) 533-6000
Expanded uncertainty UCRM: The expanded uncertainty UCRM is calculated as UCRM=k·uCRM, where
k=2 is the coverage factor for a 95 % coverage probability and uCRM is
the combined standard uncertainty in accordance to ISO Guide 34.

uCRM  u 2 Characterisation  u 2 Homogeneity  u 2 Stability


The combined standard uncertainty uCRM is obtained from the standard
uncertainties of the characterisation, the homogeneity and the
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.
ucharacterisation in the certified value is calculated
in accordance to EA-4/02 and GUM.
UCharacterisation is 0.0007 % (0.007 mg/g) (calculated as
UCharacterisation = k·uCharacterisation with k=2)

uHomogeneity is the between-bottle variation in accordance with


ISO Guide 34. 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 Guide 34. The
stability studies are the basis for the quantification of
the minimum shelf life of this water standard for the
unopened ampoule.

Instructions for correct use 1. Open ampoule at the marked point of break.
2. Rinse a plastic syringe 1-2 times with about 1 ml of standard
solution.
3. Draw up the entire ampoule content into the rinsed syringe.
4. Weigh the filled syringe before injection.
5. Inject about 1-2 ml of standard solution into the titration cell and
start the titration.
6. Determine the exact standard solution weight by reweighing the
syringe after injection.
7. Repeat the determination. The content of one ampoule is
sufficient for 3 determinations. Open the ampoule only directly
prior to starting of measurement. Solvent in the opened ampoule
can absorb moisture and distort results.

Merck KGaA – Frankfurter Straße 250, 64293 Darmstadt, Germany: +49 6151 72-0
EMD Millipore Corp. – 290 Concord Road, Billerica, MA 01821, USA: (781) 533-6000

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