White or almost white, crystalline powder or colourless crystals
Solubility (USP)
Soluble in water, practically insoluble in ether, in alcohol, and in acetone
Solubility (JP)
It is freely soluble in formic acid, soluble in water and practically insoluble in ethanol (95%). It dissolves in dilute hydrochloric acid
Solubility (EP, BP)
Soluble in water, very slightly soluble in ethanol (96%).
Identification : FTIR (USP)
Matches with the standard pattern
Identification, FTIR, dried substance (JP)
Matches with the standard pattern
Identification A, specific rotation (EP, BP)
+26.5 to +29.0 (c = 8% in HCl R1, at 20 ± 0.5°C, dried substance)
Identification B, FTIR (EP, BP)
Matches with the standard pattern
Identification C, TLC (EP, BP)
The principle 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
Appearance of solution (EP, BP)
Solution of 2.5g in 100 mL of water is clear and not more intensely coloured than reference solution BY6
Colour and clarity of solution (JP)
Solution of 0.5g in 20 mL of water is clear and colourless
pH (5% in water at 25°C) (USP)
5.50 - 7.00
pH (2.5% in water at 25°C) (JP)
5.50 - 6.50
Chloride (USP)
<= 0.05%
Chlorides (EP, BP)
<= 0.02%
Chlorides (JP)
<= 0.021%
Sulfates (USP)
<= 0.03%
Sulfates (EP, BP)
<= 0.03%
Sulfates (JP)
<= 0.028%
Iron (USP)
<= 0.003%
Iron (EP, BP)
<= 0.001%
Ammonium (JP)
<= 0.02%
Ammonium (Amino acid analysis) (EP, BP)
<= 0.02%
Arsenic (JP)
<= 0.0002%
Heavy metals (JP)
<= 0.0020%
Sulfated ash (EP, BP)
<= 0.10%
Specific rotation (EP, BP)
+26.5 to +29.0° (c = 8% in HCl R1, at 20 ± 0.5°C, dried substance)
Specific rotation (JP)
+26.5 to +29.0° (c = 8% in 6M HCl at 20°C, dried substance)
Specific rotation (USP)
+26.6 to +28.8° (c = 8% in 6N HCl at 25°C)
Residue on ignition (JP, USP)
<= 0.10%
Loss on drying (at 105°C, 2 hr) (EP, BP)
<= 0.5%
Loss on drying (at 105°C, 3 hr) (USP, JP)
<= 0.3%
Related substances : TLC (JP)
The spot other than the principal spot from the sample solution are not more intense than the spot from the standard solution
Ninhydrin-positive substances, System suitability: Resolution, Amino acid analysis (EP, BP)
>= 1.5 between the peaks due to impurities B and C
Ninhydrin-positive substances: Impurity B at 570nm, Amino acid analysis (EP, BP)
<= 0.40%
Ninhydrin-positive substances: Each impurity, Amino acid analysis (EP, BP)
<= 0.20%
Ninhydrin-positive substances: Total impurities, Amino acid analysis (EP, BP)
<= 1.0%
Related compounds : System suitability : TLC (USP)
The chromatogram of the system suitability solution exibits two clearly separated spot
Related compounds : Individual impurity : TLC (USP)
<= 0.5%
Related compounds : Total impurity : TLC (USP)
<= 2.0%
Assay (NT, dried substance) (EP, BP)
98.50 - 101.00%
Assay (NT, on dry basis) (USP)
98.50 - 101.50%
Assay (NT, dried substance) (JP)
min. 98.50%
Storage and Shelf Life
Storage
Store below 30°C.
Shelf life
48 months.
Usage
Use before expiry date given on the product label.