L(+)-Sodium lactate solution ∼50%, EMPROVE® EXPERT Ph. Eur., BP, USP suitable for use as excipient, SAFC®

L(+)-Sodium lactate solution ∼50%, EMPROVE® EXPERT Ph. Eur., BP, USP suitable for use as excipient, SAFC®

:867-56-1

:C₃H₅NaO₃

:MFCD00066576

:112.06 g/mol

:109 °C (1013 hPa)

:1.263 g/cm3 (20 °C)

:M-Clarity™ quality level = MQ500 (more info.)

:Ambient

:200-772-0

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