99.5 Percent Purity Pharmaceutical Intermediate Applications in API Manufacturing Processes stands out as a vital high-purity intermediate designed for use in the synthesis of active pharmaceutical ingredients. Identified by the CAS number {cas_number}, this compound is defined by its molecular formula {molecular_formula} and a molecular weight of {molecular_weight}. For unambiguous referencing, its IUPAC name is {iupac_name} and it is further distinguished by the InChIKey {inchikey}. As a pharmaceutical intermediate, this material plays a crucial role in facilitating multistep API manufacturing where consistent quality and traceability are imperative.
In terms of physical and chemical specifications, customers benefit from a well-characterized substance with key properties documented for process planning and safety assessment. {If boiling_point provided: The compound’s boiling point is {boiling_point}.} {If melting_point provided: Its melting point is measured at {melting_point}.} {If density provided: The density is reported as {density}.} {If flash_point provided: It features a flash point of {flash_point}.} {If vapor_pressure provided: The vapor pressure of this substance is {vapor_pressure}.}
When addressing regulatory and compliance requirements, buyers can be assured of transparency and alignment with global standards. For REACH registration, the substance’s status is referenced in accordance with article {ECHA article number} within the proper tonnage band as submitted to the European Chemicals Agency. The listing on the TSCA inventory is in compliance with section {TSCA section reference}, confirming its eligibility for manufacture, import, and commercial use in the United States. ICH guidance is adhered to according to {full ICH code and revision} with the specific impurity or exposure limit indicated by the guideline itself. Any GHS classification is fully disclosed, including all hazard statements (H-phrases) and, where applicable, the assigned signal word. Relevant pharmacopeia references from national or international compendia are cited with the corresponding chapter numbers, and occupational exposure limits such as OSHA PEL or NIOSH REL are provided when issued.
The primary applications of this material are found in its essential function as a pharmaceutical intermediate in API manufacturing. Its role enables efficient and controlled chemical reactions in drug substance synthesis, contributing to consistency in yield and purity. The compound is often chosen based on its intermediacy in the synthetic route for specific target drugs, as outlined in the PubChem database and similar resources. While the material is not itself therapeutically active, its importance lies in enabling pathways to essential medicines.
For packaging, the industry prefers robust containment to maintain quality and ensure safety. Standard options include 25-kilogram drums, 200-kilogram drums for larger volume requirements, and intermediate bulk containers (IBCs) for bulk manufacturing scenarios. Storage recommendations align with the substance’s GHS stability data, emphasizing a cool, dry, and well-ventilated environment, away from sources of ignition or incompatible chemicals. Shelf life guidance is determined following best practices for pharmaceutical intermediates, typically suggesting usage within two years of manufacture if stored under optimal conditions.
All information provided in this overview is referenced from established and authoritative sources, including the PubChem database at https://pubchem.ncbi.nlm.nih.gov/compound/{cid}, NIST Chemistry WebBook at https://webbook.nist.gov/cgi/cbook.cgi?Name={cas_number}, the ECHA portal at {echa_url}, and the EPA TSCA Inventory via https://www.epa.gov/tsca-inventory.
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