Gabapentin
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
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