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106522 Sodium-(S)-lactate-solution about 50%

EMPROVE® EXPERT Ph Eur,BP,USP

Sodium-(S)-lactate-solution about 50% MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
Grade: Ph Eur,BP,USP
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106522
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Overview

Replacement Information

Key Spec Table

Grade Value
Ph Eur,BP,USP

Products

Catalogue NumberPackaging Qty/Pack
1065222500 Plastic bottle 2.5 l
1065229019 Plastic container 19 l
Description
Catalogue Number106522
References
Product Information
GradePh Eur,BP,USP
HS Code2918 11 00
Structure formula ImageStructure formula Image
Quality LevelMQ500
Applications
Biological Information
Physicochemical Information
Boiling point109 °C (1013 hPa)
Density1.263 g/cm3 (20 °C)
pH value6.5 - 9.0 (H₂O)
Dimensions
Materials Information
Toxicological Information
Safety Information according to GHS
Storage class10 - 13 Other liquids and solids
WGKWGK 1 slightly hazardous to water
Disposal3
Relatively unreactive organic reagents should be collected in container A. If halogenated, they should be collected in container B. For solid residues use container C.
Safety Information
Product Usage Statements
Storage and Shipping Information
StorageStore at +15°C to +25°C.
Packaging Information
Transport Information
Declaration (railroad and road) ADR, RIDKein Gefahrgut
Declaration (transport by air) IATA-DGRNo Dangerous Good
Declaration (transport by sea) IMDG-CodeNo Dangerous Good
Supplemental Information
Specifications
Assay (Perchloric acid titration)#50.0 - 51.0 %
Assay (Stereochemical purity of Sodium-(S)-lactate)#≥ 95.0 %
Identity (Sodium) passes test
Identity (Lactat)passes test
Appearance of solutionClear and not more intense in color than reference solution BY₇
pH (in present substance)6.5 - 9.0
Chloride (Cl)#≤ 50 ppm
Sulfate (SO₄) (Ph Eur)#≤ 100 ppm
Sulfate (SO₄) (USP)passes test
Al (Aluminium)≤ 0.1 ppm
Fe (Iron)#≤ 10 ppm
K (Potassium)≤ 100 ppm
Oxalate and Phosphate (Ph Eur)passes test
Citrate, Oxalate, Phosphate or Tartrate (USP)passes test
Methanol and Methyl Esters≤ 250 ppm
Reducing sugars and sucrose (Ph Eur)passes test
Sugar (USP)passes test
Methanol#≤ 50 ppm
Residual solvents (ICH Q3C)excluded by manufacturing process
Total aerobic microbial count (TAMC)≤ 100 CFU/ml
Total combined yeasts/moulds count (TYMC)≤ 10 CFU/ml
Bile-tolerant gram-negative bacteria (absent in 1 ml)passes test
Candida albicans (absent in 1 ml)passes test
Escherichia coli (absent in 1 ml)passes test
Pseudomonas aeruginosa (absent in 1 ml)passes test
Salmonella (absent in 10 ml)passes test
Staphylococcus aureus (absent in 1 ml)passes test
Endotoxins< 5
#calculated on sodium lactate
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 (*).
Corresponds to Ph Eur, BP, USP
#calculated on sodium lactate
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 (*).
Corresponds to Ph Eur, BP, USP
Global Trade Item Number
Catalogue Number GTIN
1065222500 04022536078212
1065229019 04022536532400

Documentation

Material Qualification Dossier

TitleVersion
9.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Sodium-(S)-lactate-solution about 50% SDS

Title

Safety Data Sheet (SDS) 

Sodium-(S)-lactate-solution about 50% Certificates of Analysis

Product Number PackagingSpecificationLot Number
1065222500 Plastic bottlePDF Specification Document
1065229019 Plastic containerPDF Specification Document

Certificates

Title