L(+)-Sodium lactate solution ∼50%, EMPROVE® EXPERT Ph. Eur., BP, USP suitable for use as excipient, SAFC®
Supplier: MERCK PRODUCTION CHEMICALS
Synonyms:
Sodium (S)-2-hydroxypropanoate, (S)-(+)-2-Hydroxypropanoic acid sodium salt, (S)-(+)-2-Hydroxypropionic acid sodium salt, Sodium-(S)-lactate, (S)-(+)-Lactic acid sodium salt, L(+)-Lactic acid sodium salt
M-Clarity™ quality level = MQ500 (more info.)
1.06522.2500
1.06522.9019
1.06522.2500EA
563
GBP
1.06522.2500
1.06522.9019
L(+)-Sodium lactate solution ∼50%, EMPROVE® EXPERT Ph. Eur., BP, USP suitable for use as excipient, SAFC®
L(+)-Sodium lactate
Sodium-(S)-lactate-solution about 50%
Formula:
C₃H₅NaO₃ MW: 112,06 g/mol Boiling Pt: 109 °C (1013 hPa) Density: 1,263 g/cm3 (20 °C) Storage Temperature: Ambient |
MDL Number:
MFCD00066576 CAS Number: 867-56-1 EINECS: 200-772-0 |
Specification Test Results
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 |
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