In the pharmaceutical industry, the journey from basic chemical components to life-saving medications involves a series of precise steps, with pharmaceutical intermediates playing a crucial role. Understanding the specifications of these intermediates is key to ensuring the quality and safety of the final drug product. This article focuses on 11-(1-Piperazinyl)-dibenzo[b,f][1,4]thiazepine dihydrochloride (CAS 111974-74-4), a vital intermediate used in the synthesis of Quetiapine fumarate, to illustrate the importance of detailed specifications.

The primary purpose of a specification sheet for a pharmaceutical intermediate like 11-(1-Piperazinyl)-dibenzo[b,f][1,4]thiazepine dihydrochloride is to define the acceptable quality attributes. A typical specification for this compound includes a high assay of ≥99.0%, indicating a very pure substance. The appearance is generally described as a white or almost-white powder, a visual confirmation of its processed state. Beyond these basic descriptors, critical parameters relate to controlling impurities and residual substances.

For example, limits are set for moisture content (≤5.0%), Residue on Ignition (ROI, ≤1.0%), and specific organic impurities such as Piperazine content (≤0.2%), N,N-Dimethylaniline (≤45ppm), Thiazepine (≤0.30%), and DBTP-thiazepine (≤0.50%). Furthermore, residual solvents like chloromethane (≤200ppm), toluene (≤100ppm), chloroform (≤100ppm), and chloroethane (≤200ppm) are tightly controlled. These limits are derived from extensive research and regulatory guidance to ensure that the intermediate will not negatively impact the downstream synthesis or the final API's safety profile.

NINGBO INNO PHARMCHEM CO.,LTD. is committed to meeting and exceeding these demanding specifications. By implementing robust pharmaceutical intermediate quality control processes, NINGBO INNO PHARMCHEM CO.,LTD. ensures that every batch of 11-(1-Piperazinyl)-dibenzo[b,f][1,4]thiazepine dihydrochloride conforms to the highest standards. This attention to detail in defining and meeting specifications is fundamental to the reliability and efficacy of the medicines that incorporate these essential building blocks, ultimately benefiting patient health worldwide.