Short Description:
Gabapentin(Gabapentin hydrochloride)
CAS Number: 60142-96-3
Molecular Formula: C9H17NO2
Standard: USP32
Package: 25kg/drum
Description:
Gabapentin(Gabapentin hydrochloride)
CAS Number: 60142-96-3
Molecular Formula: C9H17NO2
Standard: USP32
Package: 25kg/drum
| ITEMS | LIMIT |
| Appearance | White crystalline powder |
| Identification | A. IR Spectrum should comply with the CRS |
| B. HPLC-RT should comply with the CRS | |
| pH | 6.5~8.0 |
| Water | NMT 0.5% |
| Residue on ignition | NMT 0.1% |
| Heavy Metals | NMT 0.002% |
| Early eluting impurities | Impurity A: NMT 0.1% |
| Impurity B: NMT 0.06% | |
| Impurity E: NMT 0.10% | |
| Impurity CDMA: NMT 0.10% | |
| Max individual impurity: NMT 0.10% | |
| Late eluting impurities | Impurity D: NMT 0.10% |
| Impurity CAI: NMT 0.10% | |
| Max individual impurity: NMT 0.1% | |
| Total impurity (early and late) | NMT 0.5% |
| Residual solvent | Methanol: NMT 0.3% |
| Isopropanol: NMT 0.5% | |
| Methylene chloride: NMT 0.06% | |
| Toluene: NMT 0.089% | |
| Assay (anhydrous basis) | 98.0 ~ 102.0% |
| Note | CDMA: 1,1-cyclohexane diacetic acid mono amide |
| CAI: 3,3-pentamethylene glutarimide |
