Buspirone Hydrochloride API (CAS 33386-08-2): Essential Raw Material for Anxiolytic Drugs

Authored by NINGBO INNO PHARMCHEM CO.,LTD.

In the complex and highly regulated world of pharmaceutical production, the quality and reliability of active pharmaceutical ingredients (APIs) are of utmost importance. These raw materials serve as the fundamental building blocks for nearly all medications. Among these essential compounds is Buspirone Hydrochloride, identified by its unique Chemical Abstracts Service (CAS) number 33386-08-2. This API is widely recognized for its therapeutic properties as an anxiolytic agent, primarily used in the management of anxiety disorders.

Buspirone Hydrochloride is the monohydrochloride salt of buspirone. Its correct chemical structure is reflected in the molecular formula C21H31N5O2•HCl. In its pure form suitable for pharmaceutical use, it typically appears as a white to off-white crystalline powder. This physical state is crucial for its handling, storage, and formulation into various finished dosage forms such as tablets. The crystalline nature contributes to factors like flowability and stability, which are important considerations for pharmaceutical manufacturers.

The mechanism of action of Buspirone Hydrochloride distinguishes it from other common anxiolytics, particularly benzodiazepines. Instead of acting on the GABAergic system, buspirone primarily functions as a partial agonist at serotonin 5-HT1A receptors and also exhibits effects on dopamine D2 receptors. This unique pharmacological profile contributes to its anxiolytic effects with a lower potential for sedation, muscle relaxation, and the risk of dependence that is often associated with benzodiazepines. This makes Buspirone Hydrochloride a valuable therapeutic option, especially for patients requiring long-term treatment for generalized anxiety disorder.

For Buspirone Hydrochloride powder to be incorporated into medicinal products, it must meet stringent quality standards, adhering to pharmacopoeial requirements such as those outlined in the United States Pharmacopeia (USP), European Pharmacopoeia (EP), or Japanese Pharmacopoeia (JP). Achieving and maintaining pharmaceutical grade purity is non-negotiable. This involves rigorous testing to ensure the API's chemical identity, assay (purity level), limits on impurities (including related substances, residual solvents, heavy metals), water content, and physical properties like melting point.

A high assay value, typically specified to be between 98.0% and 102.0% on a dry basis, is a key indicator of quality for Buspirone Hydrochloride API. Furthermore, controlling the levels of individual and total impurities is critical. Low impurity levels, often required to be well below 0.5% for individual impurities and 1.0% for total impurities, are essential for the safety, stability, and efficacy of the final drug product. Manufacturers rely on comprehensive Certificates of Analysis (CoA) that document these test results, demonstrating compliance with established standards.

The synthesis and purification processes involved in producing high-quality Buspirone Hydrochloride CAS 33386-08-2 require sophisticated chemical expertise and adherence to Good Manufacturing Practices (GMP). These practices ensure consistency between batches and minimize the risk of contamination. From the sourcing of starting materials to the final drying and packaging of the API powder, every step must be carefully controlled and documented.

Reliability in the supply chain is paramount for pharmaceutical companies. Sourcing Buspirone Hydrochloride raw material from a dependable supplier is crucial to ensure a consistent flow of high-quality API for continuous drug production. Factors such as production capacity, lead times, packaging integrity (often standard export packaging designed to protect the hygroscopic powder), and logistical efficiency play significant roles in the selection of a supply partner.

The global market for anxiolytic medications remains significant, driven by the prevalence of anxiety disorders. As a well-established and effective API with a favorable safety profile compared to some older alternatives, Buspirone Hydrochloride continues to be an important component in treating these conditions. Pharmaceutical companies involved in the formulation of anti-anxiety drugs are perpetually in search of trusted sources for pharmaceutical Buspirone Hydrochloride.

Understanding the detailed specifications, regulatory landscape, and market dynamics associated with Buspirone Hydrochloride API powder is vital for stakeholders in the pharmaceutical supply chain. The demand for high-purity, compliant raw materials underscores the importance of selecting experienced and reputable manufacturers and suppliers.

For those looking to buy Buspirone Hydrochloride or purchase Buspirone Hydrochloride, considering factors like the reputation of the Buspirone Hydrochloride supplier or Buspirone Hydrochloride powder manufacturer, their track record in quality control, regulatory documentation support, and competitive Buspirone Hydrochloride price are essential steps. A reliable manufacturer of Buspirone Hydrochloride can be a strategic partner in ensuring the successful and compliant production of vital medications.

This informational overview is presented by NINGBO INNO PHARMCHEM CO.,LTD., highlighting the significance and quality requirements for Buspirone Hydrochloride API within the pharmaceutical industry.