White or almost white, crystalline powder or colourless crystals
Appearance (JP)
White deliquescent crystals or crystalline powder.
Appearance (USP)
White crystals
Solubility (EP, BP)
Very soluble in water, freely soluble in ethanol (96%)
Solubility (JP)
Very soluble in water and in formic acid, and slightly soluble in ethanol (99.5%).
Solubility (USP)
Freely soluble in water and in absolute alcohol; insoluble in ether, in butanol, and in isopropanol
Clarity and color of solution (JP)
The solution 1.0 gm dissolved in 10 mL of water is clear and colourless
Identification : FTIR (JP)
Matches with the standard pattern
Identification A : FTIR (USP)
Matches with the standard pattern
Identification A : Specific optical rotation (EP, BP)
-86.0° to -84.0° (c = 4% 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 test solution is similar in position, colour and size to the principal spot in the chromatogram obtained with reference solution
Appearance of solution (EP, BP)
Solution of 2.5 gm in 50 mL of water is clear and colourless
pH (10% in water at 25°C) : (JP)
5.9-6.9
Specific optical rotation : (EP, BP, JP)
-86.0° to -84.0° (c = 4% in water at 20 ± 0.5°C, dried substance)
Specific optical rotation : (USP)
-86.3° to -84.3° (c = 4% in water at 25°C)
Chloride (JP)
<= 0.021%
Chloride (USP)
<= 0.05%
Chloride (EP, BP)
<= 0.02%
Sulphate (JP)
<= 0.028%
Sulphate (USP)
<= 0.03%
Sulphate (EP, BP)
<= 0.03%
Iron (EP, BP, JP)
<= 0.001%
Iron (USP)
<= 0.003%
Ammonium (JP)
<= 0.02%
Heavy metals (JP)
<= 0.001%
Loss on drying (at 105°C, till constant weight) : (EP, BP)
<= 0.5%
Loss on drying (at 105°C, 3hr) : (USP)
<= 0.4%
Loss on drying (at 105°C, 3hr) : (JP)
<= 0.3%
Sulfated ash (EP, BP)
<= 0.1%
Residue on ignition (JP)
<= 0.1%
Residue on ignition (USP)
<= 0.4%
Related substances, system suitability 1, HPLC: resolution (JP)
>= 1.2 between the peaks of glycine and alanine
Related substances, system suitability 2, HPLC : RSD of peak height of each amino acid other than proline in standard solution (JP)
<= 5.0%
Related substances, system suitability 3, HPLC : RSD of the retention time (JP)
<= 1.0%
Related substances, Amount of each amino acid other than proline: (JP)
<= 0.1%
Related compounds (TLC): Acceptance criteria (USP)
Any secondary spot of the sample solution is not larger or more intense than the principal spot of the standard solution
Related substances (TLC) : individual impurities (USP)