Impurity Removal in Pharmaceutical API Purification by Liquid Extractants, identified by its CAS number, represents a crucial component in modern pharmaceutical manufacturing. This product is specifically engineered to facilitate the effective removal of impurities during the purification of active pharmaceutical ingredients (APIs). For scientific clarity and traceability, its molecular characteristics—including molecular formula, molecular weight, IUPAC name, and InChIKey—are provided as reference points for researchers and regulatory submissions. As a specialized reagent, this extractant serves a defined role in pharmaceutical processing rather than acting directly as an API or excipient.
In terms of its physical and chemical attributes, the product demonstrates key specifications critical for process control. Boiling point, melting point, density, flash point, and vapor pressure provide insights into optimal handling and operational safety, forming the foundation for safe and efficient plant operations. Each property contributes to understanding how the extractant will behave under various processing conditions, ensuring it can be used consistently in a range of purification protocols.
Navigating the intricate environment of pharmaceutical regulation, this extractant aligns with primary global compliance standards. According to REACH, its registration status, associated article numbers, and tonnage band assure users of its legal placing on the European market under statutory requirements. The TSCA inventory status, bolstered by its relevant section reference, confirms authorization for commercial use in the United States. Any ICH guidelines cited clarify the maximum allowable limits for related impurities in a pharmaceutical context, with each guideline referenced by its full code and revision—providing assurance for manufacturers seeking seamless regulatory audits. If applicable, the product’s GHS hazard classification, including specific hazard phrases and its designated signal word, supports comprehensive risk management during storage and handling. Recognition in pharmacopeial references, complete with precise chapter numbers, offers further regulatory credibility, while occupational exposure limits like OSHA PEL or NIOSH REL ensure that the health of personnel remains paramount during production.
As a liquid extractant explicitly developed for impurity removal, this reagent is widely utilized in the purification of a broad spectrum of pharmaceutical APIs. Its application is pivotal in drug synthesis routes where selective extraction and removal of undesirable side products, process impurities, or residual solvents are critical to achieving exceptionally high API purity. Used routinely in both laboratory-scale and large-scale industrial settings, the product supports the production of numerous finished pharmaceuticals by making final APIs meet stringent regulatory and pharmacopoeial purity benchmarks. Its design aligns with established use cases documented in major chemical databases and manufacturing protocols.
Standard packaging for this class of reagent generally includes industrial-grade drums—typically offered in 25-kilogram and 200-kilogram sizes—as well as intermediate bulk containers for greater operational flexibility. To preserve optimum performance and stability, storage in a well-ventilated, dry environment away from incompatible materials is recommended, following the GHS chemical stability data for similar compounds. The typical shelf life for reagents of this category, when properly stored, commonly aligns with industry best practices—usually ranging from one to three years, depending on conditions and container integrity.
The information provided draws upon leading scientific and regulatory resources. Details can be referenced directly in PubChem, the NIST Chemistry WebBook, the European Chemicals Agency (ECHA), and the EPA TSCA Inventory.
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