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

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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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