| Function: | Drug Treatment of Mental Disorder |
|---|---|
| Grade Standard: | Medicine Grade |
| State: | Powder |
| Volatile: | Not Volatile |
| Standard: | USP;Cp |
| Transport Package: | Drum |
| Samples: |
|---|
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Audited Supplier | product name | quetiapine fumarate | standard:USP43 |
| items | specifications | results |
| appearance | white to off-white crystalline powder | white crystalline powder |
| Identification | A:The IR spectrum is concordant with the reference standard | conforms |
| B:The retention time of the major peak of the Sample solution corresponds to that of the Standard solution,as obtained in the Assay. | conforms | |
| Loss on drying | NMT 0.5% | 0.03% |
| Residue on ignition | NMT 0.1% | 0.03% |
| Related compounds(HPLC) | Quetiapine related compound G:NMT0.15% | None detected |
| Quetiapine related compound B:NMT0.15% | None detected | |
| Quetiapine desethoxy:NMT0.15% | None detected | |
| N-Ethyl quetiapine:NMT0.15% | None detected | |
| Bis(dienzopiperazinyl)piperazine:NMT0.10% | None detected | |
| Quetiapine tetraethylene alycol analog:NMT0.10% | None detected | |
| Any other unknown individual impurity:NMT 0.10% | 0.04% | |
| Total impurities:NMT0.50% | 0.12% | |
| Residual solvents(GC) | Ethanol:NMT2000ppm | 278ppm |
| Toluene:NMT400ppm | None detected | |
| Bulk density | 0.40g/ml | |
| Assay(HPLC) | NLT 98.0%&nmt102.0%(cALCULATED ON THE DRIED BASIS) | 100.1% |
| Storage | Preserved in tight and light resistant container Temperature:≤30ºC |
|
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Audited Supplier 
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