China (Mainland)
- Product Details
Keywords
- Gabapentin
- 60142-96-3
- anti-epileptic
Quick Details
- ProName: Gabapentin
- CasNo: 60142-96-3
- Molecular Formula: C9H17NO2
- Appearance: White OR off-white crystalline powder
- Application: anti-epileptic
- DeliveryTime: Within 7days
- PackAge: 25kg/drum
- Port: Shanghai, Hangzhou, Tianjin, Qingdao.....
- ProductionCapacity: 100 Kilogram/Month
- Purity: 99%
- Storage: Sealed keeped in cool and dry place, k...
- Transportation: By air, sea, courier, according to the...
- LimitNum: 100 Gram
- Related Substances: <0.1%
- Residue on Ignition: <0.1%
- Heavy Metal: <20PPM
- Valid Period: 2017
Superiority
|
Items |
Specifications |
|
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 |
Not more than 0.5% |
|
Residue on ignition |
Not more than 0.1% |
|
Heavy metals |
Not more than 0.002% |
|
Early eluting impurities |
Impurity A: not more than 0.1% |
|
|
Impurity B: not more than 0.06% |
|
|
Impurity E: not more than 0.10% |
|
|
Impurity CDMA: not more than 0.10% |
|
|
Max individual impurity: not more than 0.10% |
|
Late eluting impurities |
Impurity D: not more than 0.10% |
|
|
Impurity CAI: not more than 0.10% |
|
|
Max individual unknown impurity: not more than 0.10% |
|
Total impurity(Early and Late ) |
Not more than 0.5% |
|
Residual solvent |
Methanol: Not more than 3000ppm |
|
|
Isopropanol: Not more than 5000ppm |
|
|
Methylene chloride: not more 600ppm |
|
|
Toluene: Not more than 890ppm |
|
Assay(Calculated on the anhydrous basis) |
98.0-102.0% |
Details
|
Items |
Specifications |
|
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 |
Not more than 0.5% |
|
Residue on ignition |
Not more than 0.1% |
|
Heavy metals |
Not more than 0.002% |
|
Early eluting impurities |
Impurity A: not more than 0.1% |
|
|
Impurity B: not more than 0.06% |
|
|
Impurity E: not more than 0.10% |
|
|
Impurity CDMA: not more than 0.10% |
|
|
Max individual impurity: not more than 0.10% |
|
Late eluting impurities |
Impurity D: not more than 0.10% |
|
|
Impurity CAI: not more than 0.10% |
|
|
Max individual unknown impurity: not more than 0.10% |
|
Total impurity(Early and Late ) |
Not more than 0.5% |
|
Residual solvent |
Methanol: Not more than 3000ppm |
|
|
Isopropanol: Not more than 5000ppm |
|
|
Methylene chloride: not more 600ppm |
|
|
Toluene: Not more than 890ppm |
|
Assay(Calculated on the anhydrous basis) |
98.0-102.0% |
