Description
Anhydrous lactose appears as white to off-white crystalline particles or powder. Various commercial brands of anhydrous lactose are available, containing both anhydrous β-lactose and anhydrous α-lactose. Typically, anhydrous lactose consists of 70 to 80% anhydrous β-lactose and 20 to 30% anhydrous α-lactose.
The structural form of Lactose Anhydrous is as follows:
Stability and Storage Conditions
Brittle fracture index 0.0362
Bonding index 0.0049 (at compression pressure 177.8 MPa)
Density (true) 1.589 g/cm3 for anhydrous b-lactose
Density (bulk) 0.71 g/cm3 for SuperTab 21AN; 0.66 g/cm3 for Super-Tab 22AN.
Density (tapped) 0.88 g/cm3 for SuperTab 21AN; 0.78 g/cm3 for Super-Tab 22AN.
Melting point 223.08C for anhydrous a-lactose; 252.28C for anhydrous b-lactose; 232.08C (typical) for commercial anhydrous lactose.
Permanent deformation pressure 521.0MPa (at compression pressure 177.8 MPa)
Solubility Soluble in water; sparingly soluble in ethanol (95%) and ether; 40 g/100 mL at 258C for typical Sheffield Pharma Ingredients products.
Chemical-physical values
| Test Item | Unit | Specification |
|---|---|---|
|
Residue on ignition |
% |
NMT 0.1 |
|
Content of alpha anomer |
% |
reporting |
|
Content of beta anomer |
% |
reporting |
|
Prarticle size distribution < 45 µm |
% |
NMT 20 |
|
Particle size distribution < 150 µm |
% |
NLT 40
NMT 65
|
|
Particle size distribution < 250 µm |
% |
NLT 80 |
| Test Item | Unit | Specification |
|---|---|---|
|
Protein and light absorbing impurities in the range ol 210 – 220 nm |
|
NMT 0.25 |
|
Acidity or alkalinity |
ml |
NMT 0.4 |
|
Optical rotation (specific rotation) calculated on the anhydrous basis |
% |
NMT 55.9 NLT 54.4 |
|
Water determination |
% |
NMT 1.0 |
|
Loss on drying |
% |
NMT 0.5 |
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