Gabapentin 60142-96-3 anti-epileptic
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% |
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% |
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