PREGABALIN
Product Description
<Span style="font-style: normal; font-weight: normal; font-size: 12pt; line-height: normal; font-family: 'Times New Roman';">PREGABALIN
Specification
Tests | Specifications | Results |
Appearance | White to off-white crystalline powder | Complies |
Specific Rotation | +10°~+13° | +10.2° |
Identification | IR: similar to Reference Substance | Complies |
Loss on drying | ≤0.5% | 0.11% |
Chloride | ≤0.1% | Complies |
Residue on ignition | ≤0.1% | 0.03% |
Solvent residue | Ethyl acetate≤5000ppm | Undetected |
Isopropyl alcohol≤5000ppm | 980ppm | |
Tetrahydrofuran≤720ppm | Undetected | |
Isopropyl ether≤1000ppm | Undetected | |
Ethanol≤5000ppm | Undetected | |
Heavy metals | ≤0.001% | Complies |
Enantiomer | ≤0.15% | Undetected |
Related substance | CI-4≤0.15% | Undetected |
Mandelic Acid≤0.10% | Undetected | |
CI-6≤0.15% | Undetected | |
CI-Lactam≤0.15% | Undetected | |
Unknow impurity≤0.10% | 0.09% | |
Total impurities≤0.8% | 0.34% | |
Assay | 98.0%~102.0% | 98.9% |
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Product Categories : Fluorinated Silicone Rubber
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