Quality and Specifications of 1-Benzylpiperazine Dihydrochloride for Pharmaceutical Synthesis
In the intricate world of pharmaceutical manufacturing, the quality of starting materials and intermediates directly dictates the integrity of the final Active Pharmaceutical Ingredient (API). For the production of Donepezil hydrochloride, a vital medication used in managing Alzheimer's disease, 1-Benzylpiperazine dihydrochloride (CAS: 5321-63-1) stands out as a key intermediate. Ensuring this compound meets rigorous quality standards is not merely a procedural step; it is fundamental to patient safety and therapeutic efficacy. NINGBO INNO PHARMCHEM CO.,LTD. prioritizes these specifications to support reliable API production.
The precise specifications for 1-Benzylpiperazine dihydrochloride are meticulously defined to guarantee its suitability for pharmaceutical synthesis. A high assay purity, generally at or above 98.0%, is crucial. This ensures that the chemical is free from significant impurities that could interfere with the reaction process or contaminate the final Donepezil HCl product. The presence of trace impurities, such as piperazine and alcohol, is also closely monitored. Limits are set at a maximum of 0.5% for both piperazine and alcohol, reflecting the need for a clean precursor chemical.
Furthermore, physical properties play a significant role in the handling and processing of this intermediate. A high melting point, specified as ≥270°C, indicates the compound's stability under normal processing and storage conditions. Similarly, a low moisture content, typically ≤0.5%, is important to prevent degradation and maintain chemical reactivity. These characteristics are vital for ensuring batch-to-batch consistency and predictable outcomes in large-scale pharmaceutical manufacturing. By adhering to these detailed specifications, NINGBO INNO PHARMCHEM CO.,LTD. provides a reliable foundation for the production of critical medicines.
The commitment to these quality standards for 1-Benzylpiperazine dihydrochloride reinforces our role as a trusted supplier in the pharmaceutical supply chain. It is our belief that by providing intermediates of such caliber, we contribute directly to the advancement of healthcare solutions, particularly for conditions like Alzheimer's disease, where therapeutic success depends on meticulous chemical synthesis and unwavering quality control.
Perspectives & Insights
Chem Catalyst Pro
“This ensures that the chemical is free from significant impurities that could interfere with the reaction process or contaminate the final Donepezil HCl product.”
Agile Thinker 7
“The presence of trace impurities, such as piperazine and alcohol, is also closely monitored.”
Logic Spark 24
“5% for both piperazine and alcohol, reflecting the need for a clean precursor chemical.”