White or almost white, crystalline powder or shiny, white flakes
Appearance (JP)
White crystals or crystalline powder
Solubility (USP)
Sparingly soluble in water; very slightly soluble in methanol, in alcohol and in dilute mineral acids
Solubility (EP, BP)
Sparingly soluble in water, very slightly soluble in ethanol (96%). It dissolves in dilute mineral acids and in dilute solutions of alkali hydroxides.
Solubility (JP)
It is freely soluble in formic acid, sparingly soluble in water and practically insoluble in ethanol (95%). It dissolves in dilute hydrochloric acid.
Identification : FTIR (JP)
Matches with the standard pattern
Identification A : FTIR (USP)
Matches with the standard pattern
Identification A : Specific rotation (EP, BP)
-35.50° to -33.00° (c = 2% in water at 20 ± 0.5°C, dried substance)
Identification B : FTIR (EP, BP)
Matches with the standard pattern
Identification C : TLC (EP, BP)
The principal spot in the chromatogram obtained with the test solution is similar in position, colour and size to the principal spot in the chromatogram obtained with the reference solution
Identification D (EP, BP)
A violet-red to violet-brown colour develops.
Appearance of solution (EP, BP)
5% solution in 103 g/L solution of HCl is clear and not more intensely coloured than reference solution BY6
Clarity & colour of solution (JP)
5% solution in 1 mol/L HCl is clear and colourless
pH (1% in water at 25°C) (JP)
5.30-6.30
pH (1% in water at 25°C) (USP)
5.40 -6.00
Specific rotation (USP)
-34.70° to -32.70° (c = 2% in water at 25°C)
Specific rotation (EP, BP)
-35.50° to -33.00° (c = 2% in water at 20 ± 0.5°C, dried substance)
Specific rotation (JP)
-35.50° to -33.00° (c = 2% in water at 20°C, dried substance)
Chloride (USP)
<= 0.05%
Chloride (EP, BP)
<= 0.02%
Chloride (JP)
<= 0.021%
Sulfates (USP)
<= 0.03%
Sulfates (EP, BP)
<= 0.03%
Sulfates (JP)
<= 0.028%
Ammonium (JP)
<= 0.02%
Ammonium : Amino acid analysis (EP, BP)
Ammonium at 570 nm: not more than the area of the corresponding peak in the chromatogram obtained with reference solution C (0.02%)taking into account the peak due to ammonium in the chromatogram obtained with the blank solution