Store below 30°C away from bright light. Use before expiry date given on the product label.
Technical Specification
Meets Specification
USP-NF, EP, JP and BP testing specification
Appearance (USP)
White crystals
Appearance (EP, BP)
White or almost white, crystalline powder or colourless crystals
Appearance (JP)
White, crystals or a crystalline powder
Solubility (USP)
Soluble in water; practically insoluble in absolute alcohol and in ether
Solubility (EP, BP)
Freely soluble in water, practically insoluble in ethanol (96%)
Solubility (JP)
Freely soluble in water and in formic acid, and practically insoluble in ethanol (99.5). It dissolves in 2 mol/L hydrochloric acid TS
pH (10% in water at 25°C) : (JP)
5.20 - 6.20
Identification: FTIR (JP)
Matches with the standard pattern
Identification A : FTIR (USP)
Matches with the standard pattern
Identification A : Specific rotation (EP, BP)
+14.00° to +16.00° (10% in dilute hydrochloric acid R 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
Identification D (EP, BP)
A violet-red colour is produced
Appearance of the solution (EP, BP)
5% solution in water is clear and not more intensely coloured than reference solution BY 6
Clarity and color of solution (JP)
10% solution in water is clear and colourless
Chloride (USP)
<= 0.05%
Chloride (EP, BP)
<= 0.02%
Chloride (JP)
<= 0.021%
Ammonium (JP)
<= 0.02%
Ammonium : Amino acid analysis (EP,BP)
<= 0.02%
Heavy metals (JP)
<= 0.001%
Iron (USP)
<= 0.003%
Iron (JP, EP, BP)
<= 0.0010%
Sulphate (JP)
<= 0.028%
Sulphate (USP, EP, BP)
<= 0.03%
Optical rotation (JP)
+14.00° to +16.00° (10% in 2 mol/L hydrochloric acid TS at 20°C)
Specific rotation : (EP, BP)
+14.00° to +16.00° (10% in dilute hydrochloric acid R 20 ± 0.5°C, dried substance)
Specific rotation (USP)
+14.00° to +15.60° (c='10% in 2N hydrochloric acid at 25°C)
Loss on drying (JP)
<= 0.30% (at 105°C, 3 hr)
Loss on drying (USP)
<= 0.20% (at 105°C, 3 hr)
Loss on drying (BP, EP)
<= 0.50% (at 105°C, 2 hr)
Residue on ignition (JP, USP)
<= 0.10%
Sulfated ash (EP, BP)
<= 0.10%
Related substances : TLC (JP)
The spot other than the principal spot obtained from the sample solution is not more intense than the spot obtained from the standard solution