Appearance (Colour) | White or almost white |
Appearance (Form) | Crystalline powder |
Solubility | Freely soluble in water,very slightly soluble in ethanol (96%) |
Identification (IR Spectrum) | A) Passes |
Identification | B) By TLC C) By Chemical test |
Appearance of Solution | Solution is clear (10% in water) |
pH (5% aq. solution) | 5.9 - 6.4 |
Related substances (By HPLC) | Individual impurity : max 0.1% Any other impurities : max 0.1% Total impurities : max 0.2% |
Ninhydrin - Positive substance | Individual impurity : max 0.1% Total impurities : max 1% |
Chloride (CI) | Max. 75 ppm |
Ammonia (NH3) | At 570nm, NMT area of corresponding peak obtained from reference solution C ( 0.02%) |
Loss on drying | Max 0.5% (at 105°C for 2hrs) |
Sulphated Ash | Max 0.1% |
Assay (On dry basis) | 98.5 - 101.0% |
Reference | BP 2020 |