| Appearance (USP) |
White, crystalline powder, or lustrous, dry, colourless or white crystals |
| Appearance (EP, BP) |
White or almost white, crystalline powder, or lustrous, colourless or white or almost white crystals |
| Appearance (JP) |
White crystalline powder, or lustrous, colourless or white crystals |
| Appearance (IP) |
An almost white or colourless crystals, dry crystalline powder |
| Solubility (USP) |
Very soluble in water, slightly soluble in alcohol; practically insoluble in dehydrated alcohol |
| Solubility (EP, BP) |
Very soluble in water, slightly soluble in ethanol (96%), practically insoluble in anhydrous ethanol |
| Solubility (JP) |
It is very soluble in water, and practically insoluble in ethanol (99.5%) |
| Solubility (IP) |
Very soluble in water; freely soluble in ethanol (70%); practically insoluble in ethanol |
| Appearance of solution (USP) |
The clarity of the 500mg/mL solution is the same as that of water or its opalescence is not more pronounced than that of reference suspension I |
| Appearance of solution (EP, BP) |
50% solution in water is clear |
| Clarity of solution (JP) |
50% solution in water is clear and it's clarity is not different from water or it's opalescence is not more than that of reference suspension 1 |
| Identification (JP) |
Matches with the standard pattern |
| Identification (IP) |
An orange precipitate is produced immediately |
| Identification A : FTIR (USP, EP, BP) |
Matches with the standard pattern |
| Identification B : TLC (EP, BP) |
The principle spot in the chromatogram obtained with the test solution is sililar in position, colour and size to the principal spot in the chromatogram obtained with reference solution (a) |
| Identification C (EP, BP) |
An orange precipited is formed immediately |
| Acidity or alkalinity (IP) |
<= 0.6 mL of 0.01M sodium hydroxide is required to change the colour of the solution to pink |
| Specific rotation (USP, EP,BP, JP) |
+66.3° to +67.0° (c = 26% in water at 20 ± 0.5°C) |
| Specific rotation (IP) |
+65.9° to +67.0° (c = 10% in water at 25°C) |
| Conductivity (USP, EP, BP, JP) |
<= 35µS.cm-1 (at 20°C) |
| Colouring matter : A (IP) |
No unpleasant odour is detectable |
| Colouring matter : B (IP) |
Any fluorescence is not more intense than that of a solution containing 0.4 µg per ml of quinine sulphate in 0.005M sulphuric acid |
| System suitability : UV (USP, EP, BP, JP) |
<= 3.0, The absolute difference 2 results |
| Colour value: UV (USP) |
<= 75 (Nonparenteral grade) |
| Colour value: UV (EP, BP, JP) |
<= 45 |
| Barium (IP) |
Complies |
| Calcium (IP) |
The solution remains clear for at least 1 min. |
| Heavy metals (IP) |
<= 0.001% |
| Dextrin (IP) |
The solution remains yellow or becomes faint bluish green |
| Dextrins (USP, EP, BP, JP) |
The solution remains yellow |
| Sulphite (USP) |
The absorbance difference of the sample solution is NMT half of the absorbance difference of the reference solution |
| Sulphites (EP, BP, JP) |
<= 0.001% (Calculated as SO2) |
| Sulphites (IP) |
A blue colour develops |
| Reducing sugar (USP, EP, BP, JP) |
The blue colour does not disappear completely, ignoring any blue colour at the air and solution interface |
| Glucose and invert sugar (IP) |
The blue colour does not disappear completely. Ignore any blue colour at the air/solution interface |
| Sulphated ash (IP) |
<= 0.1% |
| Loss on drying (at 105°C, 3 hr) : (USP, EP, BP, JP) |
<= 0.1% |
| Bacterial endotoxin (USP, EP, BP) |
<= 0.25 IU/mg |
| Bacterial endotoxin (JP) |
<= 0.25 EU/mg |
| Bacterial endotoxin (IP) |
<= 0.25 U/mg |