White or almost white, crystalline powder or colorless crystals
Appearance (JP, USP)
White crystals or crystalline powder.
Solubility (EP, BP)
Freely soluble in water, very slightly soluble in ethanol (96%)
Solubility (USP)
Freely soluble in water
Solubility (JP)
Freely soluble in water and in formic acid and very slightly soluble in ethanol (95%)
Appearance of solution (EP, BP)
5% solution in water is clear and not more intensely colored than reference solution BY6
Clarity and colour of solution (JP)
The solution is clear and colorless
pH (10% in water at 25°C) : (JP)
4.70-6.20
Identification 1: FTIR (JP)
Matches with the standard pattern
Identification A : Specific rotation (EP, BP)
+21.00° to +23.50° (c = 8% in HCl R1 at 20 ± 0.5°C, dried substances)
Identification A : FTIR (USP)
Matches with the standard pattern
Identification 2 : Chloride (JP)
Complies
Identification B : FTIR (EP, BP)
Matches with the standard pattern
Identification C : TLC (EP, EP)
The principal spot in the chromatogram obtained with test solution is similar in position, colour and size to the principal spots in the chromatogram obtained with the reference solution
Identification D : (EP, BP)
A red colour develops
Identification E: Chloride (EP, BP)
It gives reaction (a) of chloride
Specific rotation (EP, BP)
+21.00° to +23.50° (c = 8% in HCl R1 at 20 ± 0.5°C, dried substances)