CAS No:60142-96-3
Shelf life:3 years
The detailed specifications are as below:
| Items | Standard | |
| Description | White or off-white crystalline powder | |
| Identification | IR:IR spectrum is consistent with Gabapentin RS | |
| HPLC:conform with the RT of the major peak in HPLC with USP Gabapentin WRS | ||
| PH | 6.5~8.0 | |
| Water | ≤0.5% | |
| Residue on ignition | ≤0.1% | |
| Heavy metals | ≤0.002% | |
| Residual solvents | Ethanol≤0.50% | |
| Related compounds | Early eluting impurities | Gabapentin related components A:≤0.1% |
| Gabapentin related components B:≤0.06% | ||
| Gabapentin related components E:≤0.10% | ||
| Individual unknown impurity:≤0.10% | ||
| Late eluting impurities | Any individual impurity:≤0.10% | |
| Total impurities | ≤0.5% | |
| Assay | 98.0%~102.0% | |
| Limit of chloride | ≤100ppm | |