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106522 Nátrium-(S)-laktát oldat, kb. 50%-os

EMPROVE® EXPERT Ph Eur,BP,USP

Nátrium-(S)-laktát oldat, kb. 50%-os MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
Grade: Ph Eur,BP,USP
106522
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Áttekintés

Replacement Information

Kulcsspecifikációk táblázata

Grade Value
Ph Eur,BP,USP

Products

KatalógusszámCsomagolás Menny./csomag
1065222500 Muanyagpalack 2.5 l
1065229019 Muanyag konténer 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 Egyéb folyadékok és szilárd anyagok
WGKWGK 1 enyhén vízszennyező
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
Storage+15°C és +25°C között tárolandó.
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
Katalógusszám GTIN
1065222500 04022536078212
1065229019 04022536532400

Documentation

Material Qualification Dossier

TitleVersion
9.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Nátrium-(S)-laktát oldat, kb. 50%-os MSDS

Title

Safety Data Sheet (SDS) 

Nátrium-(S)-laktát oldat, kb. 50%-os Certificates of Analysis

Cikkszám CsomagolásSpecifikációSarzsszám
1065222500 MuanyagpalackSpecifikációk, PDF dokumentum
1065229019 Muanyag konténerSpecifikációk, PDF dokumentum

Certificates

Title