Assay (Perchloric acid titration)# | 50.0 - 51.0 % |
Assay (Stereochemical purity of Sodium-(S)-lactate)# | ≥ 95.0 % |
Özdeşlik (Sodium) | Testi geçer |
Özdeşlik (Lactat) | Testi geçer |
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) | Testi geçer |
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) | Testi geçer |
Citrate, Oxalate, Phosphate or Tartrate (USP) | Testi geçer |
Methanol and Methyl Esters | ≤ 250 ppm |
Reducing sugars and sucrose (Ph Eur) | Testi geçer |
Sugar (USP) | Testi geçer |
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) | Testi geçer |
Candida albicans (absent in 1 ml) | Testi geçer |
Escherichia coli (absent in 1 ml) | Testi geçer |
Pseudomonas aeruginosa (absent in 1 ml) | Testi geçer |
Salmonella (absent in 10 ml) | Testi geçer |
Staphylococcus aureus (absent in 1 ml) | Testi geçer |
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 |