Detailed content
Specification parameter
Product packaging
Items | Specifications | Results | Test Method |
Appearance | White crystals or crystalline powder | Conforms | Visual |
Identification | Infrared Absorption | Conforms | USP<197K> |
Assay | 98.5~101.5% | 99.4% | USP<541> |
Residue on ignition | ≤0.3% | 0.08% | USP<281> |
Chloride(Cl) | ≤0.05% | <0.05% | USP<221> |
Sulfate(SO4) | ≤0.03% | <0.03% | USP<221> |
Iron(Fe) | ≤30ppm | <30ppm | USP<241> |
Heavy metals(Pb) | ≤15ppm | <15ppm | USP<231> |
Organic Impurities | Not more than 0.5% of any individual impurity is found;
Not more than 2.0% of total impurities is found | Conforms | USP<621> |
Specific rotation [α]D25 | +26.3°~+27.7° | +26.8° | USP<781S> |
Loss on drying | ≤0.5% | 0.25% | USP<731> |
Conclusion:This Batch Is Conforming With The Standard Of USP39. |
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