ITEMS | SPECIFICATION |
Appearance | White or off-white crystalline powder |
Identification | Meets the requirements |
PH | 6.5 ~ 8.0 |
Water | ≤ 0.5% |
Residue on Ignition | ≤ 0.1% |
Limit of Chloride | ≤ 0.01% |
Heavy Metals | ≤ 0.002% |
Residual Solvents | |
Toluene | ≤ 0.05% |
Ethanol | ≤ 0.5% |
Related Substances | |
Gabapentin Related Components A | ≤ 0.1% |
Any Unknown Impurity | ≤ 0.1% |
Total Impurities | ≤ 0.5% |
Assay | 98.0 ~ 102.0% |
Standard | USP34 |