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1 Kilogram |
Negotiable |
Gabapentin 60142-96-3 Gabapentin Powder
Inspection Item | Specification | Results |
Appearance | White or off-white crystalline powder | conforms |
Identification | IR should conforms | conforms |
HPLC should conforms | conforms | |
PH | 6.5 ~ 8.0 | 7.1 |
Heavy metals | ≤10ppm | <10ppm |
Loss on drying | ≤0.5% | 0.03% |
Residue on ignition | ≤0.1% | 0.04% |
Limit of chloride | ≤0.01% | <0.01% |
Residual solvents | Tolucne≤ 0.05% | Not detectable |
Isopropanol≤0.10% | Not detectable | |
Ethanol≤0.10% | 0.01% | |
Impurities(By HPLC) | impuniyy at RRT about 0.5%≤0.20% | 0.06% |
Gabapentin related components A≤0.10% | 0.01% | |
Any other unknown individual impurity | 0.07% | |
Total impuritics≤0.50% | 0.06% | |
Assay(HPLC) | 98.0%~102.0% | 99.60% |
Conclusion : THE PRODUCT CONFORM TO USP34 | ||
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