加巴喷丁

Appearance

White crystalline powder

White crystalline powder

Identification

A.IR spectrum should comply with the CRS

Conform

B.HPLC-RT should comply with the CRS

Conform

pH

6.5-8.0

7.2

Water

Not more than 0.5%

0.04%

Residue on ignition

Not more than 0.1%

0.02%

Heavy metals

Not more than 0.002%

Less than 0.002%

Early eluting impurities

Impurity A: not more than 0.1%

0.004%

Impurity B: not more than 0.06%

N.D

Impurity E: not more than 0.10%

N.D

Impurity CDMA: not more than 0.10%

N.D

Max individual impurity: not more than 0.10%

0.01%

Late eluting impurities

Impurity D: not more than 0.10%

N.D

Impurity CAI: not more than 0.10%

N.D

Max individual unknown impurity: not more than 0.10%

0.02%

Total impurity(Early   and Late )

Not more than 0.5%

0.09%

Residual solvent

Methanol: Not more than 3000ppm

147ppm

Isopropanol: Not more than 5000ppm

127ppm

Methylene chloride: not more 600ppm

N.D

Toluene: Not more than 890ppm

N.D

Assay(Calculated on the anhydrous basis)

98.0-102.0%

100.1%