Product Name | Gabapentin | CAS | 60142-96-3 | |||
Standard | USP | Country of Origin | China | |||
Lot No | IK201025 | Quantity | 1000kg | |||
Packaging | Drum | Manufacture Date | Oct 25 th ,2023 | |||
Date Of Test | Oct 26 th ,2023 | Expire Date | Oct 24 th ,2023 | |||
ITEM | SPECIFICATION | RESULT | ||||
Description | White or off-white crystalline powder | White crystalline powder | ||||
Identification | IR | IR spectrum is consistent with Gabapentin RS | Complies | |||
HPLC | Conform with the RT of the major peak in HPLC with USP Gabapentin WPS | Complies | ||||
PH | 6.5~8.0 | 7.4 | ||||
Water | ≤0.5% | 0.04% | ||||
Residue on ignition | ≤0.1% | 0.03% | ||||
Heavy metals | ≤0.002% | <0.002% | ||||
Residual solvents (Ethanol) | ≤0.50% | 0.01% | ||||
Late eluting impurities
-Any individual impurity |
≤0.10% | Not detected | ||||
Total impurities | ≤0.5% | 0.003% | ||||
Assay | 98.0%~102.0% | 99.9% | ||||
Limit of chloride | ≤0.01% | 0.004% | ||||
Conclusion | The product meet the testing requirements |