α-D-Lactose monohydrate USP, NF, Ph. Eur., JP

:5989-81-1

:C₁₂H₂₂O₁₁·H₂O

:MFCD00150747

:360.32 g/mol

:219 °C (dec.)

:Ambient

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)