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L(+)-Sodium lactate solution ∼50%, EMPROVE® EXPERT Ph. Eur., BP, USP suitable for use as excipient, SAFC®
  EM1.06522.2500
 :  MilliporeSigma
 :  
L(+)-Sodium lactate solution ∼50%, EMPROVE® EXPERT Ph. Eur., BP, USP suitable for use as excipient, SAFC®
  EM1.06522.2500
 :  MilliporeSigma
 :  1.06522.2500
 :  

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  • Pack type:
    Plastic bottle
  • Size:
    2,5 L
  • Cat. No.:
    EM1.06522.2500
  • Supplier no.:
    1.06522.2500

 

 

  • 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

 

 

 :
 :112.06 g/mol
 :109 °C (1013 hPa)
 :1.263 g/cm3 (20 °C)
 :M-Clarity™ quality level = MQ500 (more info.)
 :Ambient
 :867-56-1
 :C₃H₅NaO₃
 :MFCD00066576