Items | Reference Standard USP /BP / FCC |
Result |
Appearance | White or almost white, crystalline powder or crystals. |
Conforms |
Solubility | Easily dissolve in water, slightly soluble in ethanol |
Conforms |
Melt point | 92 °C - 96 °C | 93.2°C |
Assay(anhydrous basis) | 98.5%-101.0% | 99.77% |
Other Polyol (on dry base) | ≤ 1.0% | 0.09% |
Reducing sugar | ≤ 0.2% | 0.015% |
Water | ≤ 0.5% | 0.08% |
Residue on ignition | ≤ 0.1% | 0.015% |
Heavy metals | ≤ 5mg/kg | <5 mg/kg |
Arsenic | ≤ 0.5 mg/kg | 0.05mg/kg |
Lead | ≤ 0.5 mg/kg | 0.06mg/kg |
Nickel | ≤ 1 mg/kg | 0.08mg/kg |
Total count | Max. 100 CFU/g | <10CFU/g |
Coliform | Max. 3 MPN/g | <3MPN/g |
Yeast & Mold | Max. 100 CFU/g | <10CFU/g |
Conclusion | Conform to USP /BP / FCC standard. |
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