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This document provides information on sodium chloride from Merck including specifications, test results, ordering information, and links to the safety data sheet. It lists the chemical and physical properties, purity specifications, elemental impurity limits, and microbiological testing for sodium chloride intended for use in biopharmaceutical production.

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58 views3 pages

Product Details

This document provides information on sodium chloride from Merck including specifications, test results, ordering information, and links to the safety data sheet. It lists the chemical and physical properties, purity specifications, elemental impurity limits, and microbiological testing for sodium chloride intended for use in biopharmaceutical production.

Uploaded by

Biopharma Guru
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Personalized PDF Catalog


Catalogue Generated 11 October 2022
Sodium chloride, EMPROVE® bio Ph. Eur., BP, JP,
USP for biopharmaceutical production, SAFC®
Supplier: MERCK PRODUCTION CHEMICALS

Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities).
Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and
indicated (*).

Formula: NaCl MDL Number: MFCD00003477


MW: 58.44 g/mol CAS Number: 7647-14-5
Boiling Pt: 1461 °C (1013 hPa) EINECS: 231-598-3
Melting Pt: 801 °C Merck Index: 14,08599
Density: 2.17 g/cm3 (20 °C)
Storage Temperature: Ambient

Specification Test Results


Assay (argentometric; calculated on dried substance) 99.5 - 100.5 %
Identity passes test
Appearance of solution passes test
Acidity or alkalinity passes test
Bromide (Br) ≤ 0.005 %
Ferrocyanides passes test
Iodide (I) passes test
Nitrite (NO₂) (UV-absorption 354nm; 1cm; 10%; water) ≤ 0.01
Phosphate (PO₄) ≤ 0.0025 %
Sulfate (SO₄) ≤ 0.0200 %
Heavy metals (as Pb) ≤ 0.0003 %
Al (Aluminium) ≤ 0.00002 %
As (Arsenic) ≤ 0.0001 %
Ba (Barium) passes test
Ca (Calcium) ≤ 0.002 %
Fe (Iron) ≤ 0.0002 %
K (Potassium) ≤ 0.01 %
Magnesium and alkaline-earth metals (as Ca) ≤ 0.0100 %
Residual solvents (ICH Q3C) excluded by production process
Loss on drying (105 °C, 2 h) ≤ 0.5 %
Endotoxins (kinetic turbidimetric test) ≤ 2.5 I.U./g
Microbiological purity (Total aerobic microbial count (TAMC)) ≤ 100.0 CFU/g
Microbiological purity (Total yeast and mould count (TYMC)) ≤ 100.0 CFU/g
DNases (Exo- and endonucleases) (not detectable) passes test
RNases (not detectable) passes test
Proteases (not detectable) passes test
Nicking Activity (not detectable) passes test
Corresponds to Ph Eur,BP,JP,USP

ORDER

VWR Catalog Number Price Quantity Pack type Pk


1.37017.1000 £47.20 Plastic bottle 1 kg

1.37017.5000 £116.00 Plastic bottle 5 kg

SDS

1.37017.9012 £170.00 Bucket, plastic 12 kg

SDS

1.37017.9029 £288.00 Double PE Sack 25 kg

SDS

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