White or almost white crystalline powder or colourless crystals
Solubility (USP)
Soluble in water, practically insoluble in alcohol and in ether
Solubility (EP, BP)
Slightly soluble in water, practically insoluble in ethanol (96%) and in methylene chloride
pH (c = 2% in water at 25°C) (EP, BP)
4.00 - 6.00
Identification A, FTIR (USP)
Matches with the standard pattern
Identification A, Specific rotation (EP, BP)
+33.7° to +36.0° (c = 10% in 3N HCl, 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 test solution (b) is similar in position, colour and size to the principle spot in the chromatogram obtained with reference solution
Identification D, Loss on drying (at 130°C, 3hr) (EP, BP)
10.50 - 12.50%
Appearance of solution (EP, BP)
2% solution is clear and colourless.
Lead (USP)
<= 0.0005%
Chloride (EP, BP)
<= 0.02%
Sulphate (EP, BP)
<= 0.02%
Iron (EP, BP)
<= 0.001%
Ammonium (EP, BP)
<= 0.1%
Chromatographic purity, TLC (USP)
No secondary spot from the sample solution is larger or more intense than the principal spot from the standard solution (0.5%), and <= 1.0% of total impurities is found
Microbial enumeration test, TAMC (USP)
<= 1000 cfu/g
Microbial enumeration test, TYMC (USP)
<= 100 cfu/g
Related substances, system suitability, Resolution, HPLC: (EP, BP)
>= 5.0, between the peaks due to asparagine and impurity A
Related substances 1 (HPLC): Impurities A (EP, BP)
<= 0.50%
Related substances 2 (HPLC): Impurity C (EP, BP)
<= 0.1%
Related substances 3 (HPLC): Unspecified impurities for each impurity (EP, BP)
<= 0.05%
Related substances : Total impurities, HPLC (EP, BP)
<= 0.8%
Sulphated ash (EP, BP)
<= 0.1%
Residue on ignition (USP)
<= 0.1%
Specific rotation (EP, BP)
+33.7° to +36.0° (c = 10% in 3N HCl, dried substance)
Specific rotation (USP)
+33.0° to +36.5° (c = 1% in 6N HCl, at 20°C)
Loss on drying (at 130°C, 3hr) (EP, BP)
10.50 - 12.50%
Loss on drying (at 130°C, 3hr) (USP)
11.50 - 12.50%
Assay (NT, on dry basis) (USP)
98.00 - 101.50%
Assay (NT, on dry basis) (EP, BP)
99.00 - 101.00%
Storage and Shelf Life
Storage condition
Store below 30°C away from bright light.
Shelf life
48 months.
Usage instruction
Use before expiry date given on the product label.