Gabapentin hydrochloride

Inspection Item

Specification

Results

Appearance

White or off-white crystalline powder

conforms

Identification

IR should conforms

conforms

HPLC should conforms

conforms

PH

6.5 ~ 8.0

7.1

Heavy metals

≤10ppm

<10ppm

Loss on drying

≤0.5%

0.03%

Residue on ignition

≤0.1%

0.04%

Limit of chloride

≤0.01%

<0.01%

Residual solvents

Tolucne≤ 0.05%

Isopropanol≤0.10%

Ethanol≤0.10%

Not detectable

Not detectable

0.01%

Impurities(By HPLC)

impuniyy at RRT about 0.5%≤0.20%

Gabapentin related components A≤0.10%

Any other unknown individual impurity

Total impuritics≤0.50%

0.06%

0.01%

0.07%

0.06%

Assay(HPLC)

98.0%~102.0%

99.6%

 Conclusion : THE PRODUCT CONFORM TO USP34