Sodium-(S)-Lactate-Soln 50% 2.5Ltr

Description

Catalogue Number

106522

Product Information

Grade	Ph Eur,BP,USP
HS Code	2918 11 00

Physicochemical Information

Boiling point	109 °C (1013 hPa)
Density	1.263 g/cm3 (20 °C)
pH value	6.5 - 9.0 (H₂O)

Storage and Shipping Information

Storage

Store at +5°C to +30°C.

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
Heavy metals (as Pb)#	≤ 10 ppm
Al (Aluminium)	≤ 0.1 ppm
As (Arsenic)#	≤ 3 ppm
Ba (Barium)	passes test
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 lactateElemental 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