Enhanced TDS
Identification & Functionality
- Chemical Name
- Molecular formula
- (C₂₁H₂₅N₃O₂S)₂· C₄H₄O₄
- Technologies
- Product Families
- Chemical Structure
- Definition
Quetiapine Fumarate contains NLT 98.0% and NMT 102.0% of quetiapine fumarate [(C₂₁H₂₅N₃O₂S)₂ · C₄H₄O₄], calculated on the dried basis.
Applications & Uses
Properties
- Typical Properties
Value Units Test Method / Conditions Molecular Weight 883.09 - -
Regulatory & Compliance
- FDA Disclaimer
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
- USP Reference Standards
- USP Quetiapine Fumarate RS
- USP Quetiapine Related Compound B RS 11-(Piperazin-1-yl)dibenzo[b,f][1,4]thiazepine. C17H17N3S 295.40
- USP Quetiapine Related Compound G RS Dibenzo[b,f][1,4]thiazepin-11(10H)-one. C13H,NOS 227.28
- USP Quetiapine System Suitability RS: It contains quetiapine fumarate and NLT 0.1% of each of the following impurities: Quetiapine related compound B: 11-(Piperazin-1-yl)dibenzo[b,f][1,4]thiazepine; Quetiapine related compound G: Dibenzo[b,f][1,4] thiazepin-11(10H)-one; and Quetiapine desethoxy: 2-[4-(Dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl] ethanol.
Storage & Handling
- Storage Information
Preserve in well-closed containers, protected from light.