In the pharmaceutical industry, the quality of raw materials and intermediates is directly correlated with the safety and efficacy of the final drug product. Dibenz[b,e]oxepin-11(6H)-one (CAS 4504-87-4), a crucial intermediate for Doxepin synthesis, exemplifies the importance of rigorous quality assurance. This article focuses on the critical parameters that define the quality of this compound and why sourcing from reputable manufacturers is essential.

The production of pharmaceutical intermediates necessitates a multi-faceted approach to quality assurance. For Dibenz[b,e]oxepin-11(6H)-one, this begins with stringent control over its synthesis process. Key quality indicators include:

  • Assay: A minimum assay of ≥99.0% is standard, ensuring a high concentration of the desired chemical entity. This is vital for predictable reaction yields in downstream Doxepin synthesis.
  • Appearance: Described as a light brown crystalline powder, this visual characteristic provides an initial indication of product integrity.
  • Loss on Drying: A limit of ≤0.5% for loss on drying indicates low residual solvent or moisture content, crucial for stability and accurate weighing.
  • Moisture Content: Strictly controlled at ≤0.2%, low moisture prevents degradation and ensures consistent reactivity.
  • Impurity Profile: Limits on single impurities (≤0.5%) and specific contaminants like anthraquinone (≤0.5%) are critical. Uncontrolled impurities can lead to the formation of genotoxic byproducts or affect the therapeutic activity of the final API.

NINGBO INNO PHARMCHEM CO.,LTD. as a leading manufacturer and supplier of Dibenz[b,e]oxepin-11(6H)-one, places immense emphasis on these quality parameters. Our manufacturing processes are designed to meet international standards, and each batch undergoes thorough testing. We understand that pharmaceutical companies require not just the chemical itself, but also the assurance that it will perform consistently in their production lines. This commitment to quality translates into competitive prices because it reduces the risk of batch failures and costly investigations for our clients.

For procurement managers and R&D scientists, selecting a supplier that can consistently deliver Dibenz[b,e]oxepin-11(6H)-one meeting these demanding specifications is paramount. When you buy from NINGBO INNO PHARMCHEM CO.,LTD., you are choosing a partner dedicated to quality assurance. We provide comprehensive Certificates of Analysis (CoA) with each shipment, detailing all relevant quality parameters. This transparency is key to building trust and ensuring regulatory compliance for your Doxepin production. Contact us today to request a quote and learn more about our quality management systems.