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
