White or almost white, crystalline powder or colourless crystals
Appearance (JP)
White, crystals or crystalline powder
Solubility (USP)
Soluble in water; very slightly soluble in alcohol; insoluble in ether
Solubility (EP, BP)
Soluble in water, very slightly soluble in ethanol (96%)
Solubility (JP)
Freely soluble in formic acid, and soluble in water and practically insoluble in ethanol (99.5%), It dissolves in 6 mol/L HCI TS
pH (2% in water) : (JP, USP)
7.00-8.50
Identification: FTIR (JP)
Matches with the standard pattern
Identification A : FTIR (USP)
Matches with the standard pattern
Identification A : Specific rotation (dried substance) (EP, BP)
+11.40° to +12.40° (dissolve 2.75 gm in 12 mL of hydrochloric acid R1 and dilute to 25 mL with water at 20 ± 0.5°C, dried basis)
Identification B: FTIR (EР, ВР)
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)
An orange-red colour develops
Appearance of the solution (EP, BP)
5% solution in water is clear and not more intensely coloured than reference solution BY7
Clarity and color of solution (JP)
2% solution in water is clear and colourless
Chloride (USP)
<= 0.05%
Chloride (EP, ВР)
<= 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)
<= 0.001%
Sulphate (JP)
<= 0.028%
Sulphate (USP, EP, BP)
<= 0.03%
Optical rotation (JP)
+11.80° to +12.80° (c=11% in 6 mol/L hydrochloric acid TS at 20°C, dried basis)
Specific rotation (EP, BP)
+11.40° to +12.40° (dissolve 2.75 gm in 12 mL of hydrochloric acid R1 and dilute to 25 mL with water at 20 ±0.5°C, dried basis)
Specific rotation (USP)
+12.60° to +14.00° (c=11% in 6N 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, till constant weight)
Residue on ignition (JP)
<= 0.10%
Residue on ignition (USP)
<= 0.40%
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.