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α-D-Lactose monohydrate USP, NF, JP, Ph. Eur.
 :  Thermo Fisher Scientific
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α-D-Lactose monohydrate USP, NF, JP, Ph. Eur.
 :  Thermo Fisher Scientific
 

 

  • Environmentally Preferable:

 

 

  • Appearance:
    White to almost white Amorphous powder, crystals or crystalline powder
  • Water:
    4.5 to 5.5 %
  • Loss on drying:
    ≤0.5 % (80°C, 2 h)
  • Heavy metals:
    ≤5 ppm
  • UV:
    at 270 nm A: ≤0.07
  • Appearance of solution:
    Clear and not more intensely colored than ref. BY7
  • Clarity and color of solution:
    Clear and nearly colorless
  • Identification:
    Conform USP/NF, EP, JP
  • Particle size:
    50 to 65 % (≤ 45 µm)
  • Residue after ignition:
    ≤0.1 %
  • Microbial contamination:
    ≤100 CFU/g total aerobic microbial count
  • Acidity/alkalinity:
    ≤0.4 ml/6g (ml 0.1N NaOH/6g)
  • Specific optical rotation:
    +54.4° to +55.9° (20°C, 589 nm) (c=10, H2O/NH3) (After 30 min., on anhydrous substance)

 

 

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