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Basic Info

Model No.: BP USP EP

Product Description

Gabapentin 

 

Cas No.: 60142-96-3

 

Specification:

ITEMS SPECIFICATIONS RESULTS
DESCRIPTION WHITE OR OFF-WHITE CRYSTALLINE POWDER WHITE CRYSTALLINE POWDER
IDENTIFICATION
IR IR SPECTRUM IS CONSISTENT WITH GABAPENTIN RS CONFORMS
HPLC CONFORM WITH THE RT OF THE MAJOR PEAK IN HPLC WITH USP GABAPENTIN WRS CONFORMS
PH 6.5~8.0 7.1
WATER ≤   0.5% 0.04%
RESIDUE ON IGNITION ≤   0.1% 0.02%
LIMIT OF CHLORIDE ≤   0.01% 0.003%
HEAVY METALS ≤   0.02% < 0.002%
RESIDUAL SOLVENTA
TOLUENE ≤   0.05% < LOD(2PPM)
ETHANOL ≤   0.50% 0.005%
RELATED COMPOUNDS
GABAPENTIN RELATED COMPONENTA A ≤   0.10% 0.01%
ANY UNKROWN IMPURITY ≤   0.10% 0.01%
TOTAL IMPURITIES ≤   0.50% 0.03%
ASSAY 98.0%~102.0% 100.6%
CONCLUSION: THE BATCH CONFORMS WITH USP30 SPECIFICATIONS

 

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Product Categories : Pharmaceutical Raw Materials