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Merck - 1.06522.9019 - SODIUM LACTATE SOLUTION ABOUT 50% EXTRA (Each)

  • MFR SKU: 1.06522.9019
  • ITEM #: 9537033
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ITEM #: 9537033
Sodium-(S)-lactate-solution about 50%^ Sodium-(S)-lactate-solution about 50%, Suitable for use as exipient EMPROVE* exp Ph Eur, BP, USP, Cas No. 72-17-3, Molecular Formula: CH3CH(OH)COONa, Synonyms: DL-Lactic acid sodium salt, Size: 19l
This listing is for Each

Merck - 1.06522.9019 - SODIUM LACTATE SOLUTION ABOUT 50% EXTRA (Each)

  • Item #: 9537033
  • MFR SKU: 1.06522.9019
  • Catalogue Number 106522
  • Grade Ph Eur, BP, USP
  • HS Code 2918 11 00
  • Structure formula Image
  • Quality Level MQ500
  • Boiling point 109 ° C (1013 hPa)
  • Density 1.263 g/cm3 (20 ° C)
  • pH value 6.5 - 9.0 (HO)
  • Storage class 10 - 13 Other liquids and solids
  • WGK WGK 1 slightly hazardous to water
  • Disposal 3
  • Relatively unreactive organic reagents should be collected in container A. If halogenated, they should be collected in container B. For solid residues use container C.
  • Storage Store at +15° C to +25° C.
  • Declaration (railroad and road) ADR, RID Kein Gefahrgut
  • Declaration (transport by air) IATA-DGR No Dangerous Good
  • Declaration (transport by sea) IMDG-Code No Dangerous Good
  • 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 BY
  • pH (in present substance) 6.5 - 9.0
  • Chloride (Cl)# ≤ 50 ppm
  • Sulfate (SO) (Ph Eur)# ≤ 100 ppm
  • Sulfate (SO) (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 1ml) 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 10ml) 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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