Appearance (Colour)
White , odorless
Appearance (Form)
Crystals
Solubility
Freely soluble in water and in absolute alcohol
Identification (IR Spectrum)
A) Passes
Assay (On dry basis)
98.5 – 101.5%
Residue on ignition
NMT. 0.4%
Chloride (CI)
NMT. 0.05%
Sulphate (SO4)
NMT. 0.03%
Iron (Fe)
NMT. 30ppm
Related impurities
By TLC
Individual impurities : NMT 0.5%
Total impurities : NMT. 2.0%
Specific rotation [α]
-84.3° to -86.3° (40mg/ml in water)
Loss on drying
NMT. 0.4%
Reference
USP 44
