A white or almost white, crystalline powder or colourless crystals
Solubility (USP)
Soluble in water, in alcohol, and in acetone
Solubility (JP)
Very soluble in water, and soluble in ethanol (99.5%). It dissolves in 6 mol/L hydrochloric acid TS
Solubility (EP, BP)
Freely soluble in water, slightly soluble in ethanol (96%)
Identification A : FTIR (USP)
Matches with the standard pattern
Identification A : Specific optical rotation (EP, BP)
+5.50° to +7.00° (c= 8% in hydrochloric acid R1 at 25°C, dried substance)
Identification 1 : FTIR (JP)
Both spectra exhibit similar intensities of absorption at the same wave numbers
Identification 2 : Chloride (JP)
10 mL of 2% solution and 1 mL of hydrogen peroxide responds to the qualitative test for chloride
Identification B : FTIR (EP, BP)
Matches with the standard pattern
Clarity and color of solution : (JP)
10% solution in water is clear and colorless 10% solution in water is clear and colorless
Identification C : TLC (EP, ВР)
The principal 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
Identification D : (EP, BP)
The solution becomes green
Identification E: (EP, BP)
The solution gives reaction (a) of chlorides
pH (1% in water at 25°C) : (JP)
1.30-2.30
Appearance of solution (EP, ВР)
2.5% solution in water is not more intensely coloured than reference solution BY6
Clarity and color of solution : (JP)
10% solution in water is clear and colorless 10% solution in water is clear and colorless
Optical rotation : (JP)
+6.00° to + 7.50° (c= 8% in 6M hydrochloric acid at 20°C, dried bais)
Optical rotation : (USP)
+5.70° to +6.80° (c = 8% in 6N hydrochloric acid, 25°C)
Specific optical rotation : (EP, BP)
+5.50° to +7.00° (c = 8% in hydrochloric acid R1, 20 ± 0.5°C)
Sulfate : (JP)
<= 0.021%
Sulfate: (USP, EP, BP)
<= 0.03%
Heavy metals : (JP)
<= 0.0010%
Iron (JP)
<= 0.0010%
Iron (USP)
<= 0.0030%
Iron (EP, BP)
<= 0.0020%
Loss on drying (JP)
8.50 - 12.00% (in vacuum on phosphorus (V) oxide, 20 hours)
Loss on drying (USP)
8.00 - 12.00% (dry at room temperature in vacuum at pressure NMT 5 mm of mercury, 24 hr)
Loss on drying (EP, BP)
8.00 - 12.00% (at a pressure NMT 0.7kPa gor 24 hr)
Residue on ignition: (JP)
<= 0.10%
Residue on ignition : (USP)
<= 0.40%
Sulfated ash (EP, BP)
<= 0.10%
Ammonium (Amino acid analysis) : (EP, BP)
<= 0.02%
Ammonium (JP)
<= 0.02%
Related compounds, System suitability : TLC (USP)
The chromatogram of the system suitability solution exibits two clearly separated spots
Related compounds, TLC : (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 : (JP)
The spot other than the principal spot obtained with the sample solution is not more intense than the spot obtained with the standard solution.
Related compounds, Individual impurities, TLC : (USP)