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Product Name | Amantadine Hydrochloride | ||
CAS number | 665-66-7 | Structure | |
Production date | 2012/02/13 | ||
Report date | 2012/02/13 | ||
Batch number | 20120202 | ||
Retest date | 2015/02/12 | ||
Pharmacopoeia | USP34 | ||
Quantity | 275KG | ||
Items | Specifications | Results | |
Appearance | White crystalline powder | White Crystalline powder | |
Identification | Infrared Absorption | Conforms | |
Clarity and color of solution | Clear and nearly colorless | Clear and nearly colorless | |
PH | 3.0~5.5 | 4.0 | |
Heavy metals | Not more than 0.001% | <0.001% | |
Organic volatile (acetone) | Not more than 0.05% | 0.03% | |
Related substances | Individual unknown impurity:NMT0.3% Total impurities: NMT 1.0% | 0.03% 0.08% | |
Assay | 98.5%~101.5% | 100.1% | |
Conclusion | Complies with USP34 |
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