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106522 Mléčnan sodný roztok cca 50%

EMPROVE® EXPERT Ph Eur,BP,USP

Mléčnan sodný roztok cca 50% 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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Přehled

Replacement Information

Tabulka spec. kláve

Grade Value
Ph Eur,BP,USP

Products

Katalogové čísloBalení ks/bal.
1065222500 Plastová láhev 2.5 l
1065229019 Plastový kanystr 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 Ostatní kapalné a tuhé látky
WGKWGK 1 látka mírně ohrožující vody
Disposal3
Relativně nereaktivní organické reagencie mohou být shromažďovány v kontejneru A. Pokud jsou halogenované, musí být umístěny v kontejneru B. U pevných reziduí použijte kontejner C.
Safety Information
Product Usage Statements
Storage and Shipping Information
StorageSkladovat od +15°C až +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
Katalogové číslo GTIN
1065222500 04022536078212
1065229019 04022536532400

Documentation

Material Qualification Dossier

TitleVersion
9.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Mléčnan sodný roztok cca 50% MSDS

Title

Safety Data Sheet (SDS) 

Mléčnan sodný roztok cca 50% Certificates of Analysis

Katalogové číslo BaleníSpecifikaceČíslo šarže
1065222500 Plastová láhevSpecifikující dokument ve formátu PDF
1065229019 Plastový kanystrSpecifikující dokument ve formátu PDF

Certificates

Title