Sodium -(S)- lactace- solution Emprove

ürün Kodu : 106522.2500

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Description
Catalogue Number 106522
Product Information
Grade Ph Eur,BP,USP
HS Code 2918 11 00
Structure formula Image Structure formula Image
Quality Level MQ500
Physicochemical Information
Boiling point 109 °C (1013 hPa)
Density 1.263 g/cm3 (20 °C)
pH value 6.5 - 9.0 (H₂O)
Safety Information according to GHS
Storage class 10 - 13 Other liquids and solids
WGK WGK 1 slightly hazardous to water
Disposal 3
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.
Storage and Shipping Information
Storage Store at +15°C to +25°C.
Transport Information
Declaration (railroad and road) ADR, RID Kein Gefahrgut
Declaration (transport by air) IATA-DGR No Dangerous Good
Declaration (transport by sea) IMDG-Code No Dangerous Good
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 solution Clear 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
As (Arsenic)# ≤ 3 ppm
Fe (Iron)# ≤ 10 ppm
Hg (Mercury) ≤ 1 ppm
Pb (Lead) ≤ 5 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
Corresponds to Ph Eur, BP, USP

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