Daclatasvir Dihydrochloride, identified by its CAS number 1009119-65-6, stands as a pivotal Active Pharmaceutical Ingredient (API) in modern medicine. This compound is renowned for its specific therapeutic properties, making it an essential component in the development of pharmaceutical drugs, particularly those targeting certain viral infections, such as anti-hepatitis treatments. Its consistent quality and efficacy are paramount for patient outcomes globally.

At its core, an Active Pharmaceutical Ingredient (API) is the substance within a finished drug product that produces the intended pharmacological activity or therapeutic effect. Unlike excipients, which are inactive ingredients used to aid in the delivery, stability, or form of the medication, the API is solely responsible for treating, curing, mitigating, or preventing disease, or for affecting the structure and function of the body. Understanding this distinction underscores the critical importance of API quality and purity in the pharmaceutical supply chain.

The manufacturing process of Daclatasvir Dihydrochloride involves complex chemical synthesis, transforming raw materials into a highly purified drug substance. Each stage, from initial reactions to final isolation, is meticulously controlled to ensure adherence to the highest quality standards. Rigorous Good Manufacturing Practices (GMP) are strictly followed, alongside compliance with international regulations such as those set by the FDA and ISO. This stringent oversight guarantees consistency, reproducibility, and the utmost safety for all batches produced, reflecting a deep commitment to global health and patient welfare.

Our Daclatasvir Dihydrochloride presents as a white to off-white solid powder, indicative of its refined state. It boasts a purity consistently greater than 99%, with typical test results showing levels around 99.58%. Key specifications include a water content of typically ≤0.50% (measured at 0.24%), residue on ignition at ≤0.10% (measured at 0.06%), and heavy metal content strictly controlled to ≤20ppm. Total impurities are maintained below 1.00%, with any single impurity not exceeding 0.20%. These precise measurements ensure the product's integrity and performance. Proper storage is also crucial; it must be preserved in tight, light-resistant containers in a cool place to maintain its optimal stability and shelf life.

Daclatasvir Dihydrochloride, like other essential APIs, is formulated into various dosage forms, including tablets and injections, catering to diverse medical needs. The global pharmaceutical industry relies heavily on a robust and reliable API supply chain to ensure a continuous flow of life-saving medications. This interconnectivity emphasizes the need for transparency, stringent quality assurance, and ethical sourcing practices across all stages of production and distribution.

For drug manufacturers seeking a dependable supplier of premium Daclatasvir Dihydrochloride, understanding the rigorous processes and quality assurances is paramount. When considering where to buy this essential API, factors like purity, compliance, and consistent availability are key considerations for a reliable purchase. Prospective buyers should look for an established manufacturer with proven expertise in producing high-grade pharmaceutical intermediates. Inquiries regarding price and detailed specifications are always welcome to facilitate informed decisions in the API market.