α-D-Lactose monohydrate USP, NF, Ph. Eur., JP
Supplier: Thermo Scientific
Synonyms:
α-Lactose monohydrate
368892500
368890010
ACRO368892500EA
41.7
GBP
ACRO368892500
ACRO368890010
α-D-Lactose monohydrate USP, NF, Ph. Eur., JP
α-D-Lactose monohydrate
Formula:
C₁₂H₂₂O₁₁·H₂O MW: 360,32 g/mol Melting Pt: 219 °C (dec.) Storage Temperature: Ambient |
MDL Number:
MFCD00150747 CAS Number: 5989-81-1 |
Specification Test Results
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 220 nm A: ≤0.25 |
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 | ≥99 % (≤ 250 µm) |
Residue after ignition | ≤0.1 % |
Microbial contamination | (Salmonellae in 100 g) Absent |
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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