Appearance |
White to almost white crystalline powder |
Identification |
To comply IP, BP, USP tests |
Solubility |
Freely soluble in water, sparingly soluble in ethanol (96 per cent) |
Specific optical rotation (20°C, 589 nm) (C=10, H2O/dilute NH3) (Anhydrous substance) |
+52.5° to +53.3° |
Appearance of solution |
To comply BP test |
Colour of solution |
To comply USP test |
Acidity or alkalinity |
To comply IP,BP, USP test |
Sulphite |
Max 0.0015% (passes IP test) |
Heavy metal (as Pb) |
Max 0.0005% |
Barium (Ba) |
Passes IP, BP test |
Calcium (Ca) |
Passes BP test |
Lead (Pb) |
Max 0.00005% |
Loss on drying (1 g, 105°C, 16h) |
Max 0.5 % |
Foreign sugars, soluble starch, dextrins |
Max 1.0% |
Bacterial endotoxin |
Not more than 0.5 Endotoxin unit/ ml of a 5 % w/v solution |