In the pharmaceutical industry, the quality and precise specifications of raw materials directly impact the efficacy and safety of the final drug product. Polymyxin B Sulfate (CAS 1405-20-5), a potent polypeptide antibiotic, is no exception. As a leading manufacturer and supplier of this crucial intermediate, we understand the importance of adhering to rigorous quality standards. This guide will help procurement managers and R&D scientists understand the key specifications to consider when buying Polymyxin B Sulfate.

Appearance and Form: Polymyxin B Sulfate is typically supplied as a white or almost white powder. This physical characteristic is a primary indicator of its quality and processing. The form factor ensures ease of handling and integration into various pharmaceutical formulations, from sterile injectables to topical creams.

Purity and Potency: The most critical specifications revolve around purity and potency. Pharmaceutical-grade Polymyxin B Sulfate often requires a high purity level, such as 99%. Potency is usually measured in International Units (IU) per milligram (mg), with standards typically requiring not less than 6500 IU/mg on an anhydrous basis. Assay results, often determined by High-Performance Liquid Chromatography (HPLC), confirm the sum of various Polymyxin B components (B1, B2, B3, B1-1) and limit specific impurities like Polymyxin B3 and B1-1. These figures are vital for calculating accurate dosages.

Identification and Related Substances: For consistent pharmaceutical use, reliable identification methods are essential. Manufacturers must provide confirmation that the product indeed conforms to standard identification tests. Furthermore, regulatory bodies require strict control over related substances and impurities. Specifications often set limits for the major impurity (e.g., ≤3.0%) and the sum of all impurities (e.g., ≤17.0%), ensuring product safety and regulatory compliance.

Physicochemical Properties: Other important physicochemical properties include the pH of a solution (typically 5.0-7.0 for a 2% solution, 5.0-7.5 for a 0.5% solution), loss on drying (usually ≤6.0%), and sulfate ash (≤0.75%). Heavy metals content must also be within acceptable limits, often ≤20ppm. These parameters ensure the stability and compatibility of Polymyxin B Sulfate within complex pharmaceutical formulations.

Sourcing from a Reliable Manufacturer: When you purchase Polymyxin B Sulfate, ensure your supplier, like us, provides comprehensive documentation: Certificates of Analysis (CoA), Technical Data Sheets (TDS), and Material Safety Data Sheets (MSDS). This transparency is key to building trust and ensuring compliance. We, as a leading Polymyxin B Sulfate manufacturer in China, are committed to meeting these exacting standards and providing reliable supply for your pharmaceutical needs. Contact us to inquire about pricing and availability for your next order.