For any pharmaceutical company looking to procure Active Pharmaceutical Ingredients (APIs), understanding the detailed specifications of the product is of utmost importance. This is especially true for antibiotics like Cefoxitin Sodium, where purity and conformity to established standards directly impact therapeutic outcomes. This guide aims to help buyers navigate the essential specifications when sourcing Cefoxitin Sodium API.

The primary specifications for Cefoxitin Sodium revolve around its compliance with major pharmacopeias. Buyers should look for APIs that meet the standards set by the United States Pharmacopeia (USP), European Pharmacopoeia (EP), British Pharmacopoeia (BP), and Chinese Pharmacopoeia (CP). These standards dictate acceptable limits for purity, impurity profiles, physical characteristics, and other critical quality attributes. Ensuring your cefoxitin sodium USP grade meets these diverse requirements is vital for global market access.

Key parameters typically found on a Certificate of Analysis (COA) for Cefoxitin Sodium include its assay (purity, usually expressed as a percentage), specific rotation, pH of a solution, water content, residue on ignition, and heavy metals content. Impurity profiles are particularly critical, with strict limits on related substances that could affect efficacy or safety. A reliable cefoxitin sodium supplier in China, like NINGBO INNO PHARMCHEM CO.,LTD., will provide comprehensive and accurate COAs for each batch.

Beyond chemical purity, the physical form and sterility are also crucial specifications. Cefoxitin Sodium is often required in a sterile powder form for direct use in injectable formulations. This necessitates manufacturing under aseptic conditions and rigorous sterility testing. The packaging specifications, such as the quantity per tin or carton (e.g., 10kg/tin/carton), and storage conditions (e.g., preserved in a tight container) are also important to maintain product integrity during transport and storage.

When considering to buy Cefoxitin Sodium API, always inquire about the availability of Drug Master Files (DMFs) and any registration support provided by the manufacturer. These documents are essential for regulatory filings in many countries. By thoroughly understanding and verifying these specifications, buyers can ensure they are obtaining a high-quality, compliant Cefoxitin Sodium product, thereby safeguarding their own product quality and patient safety.