Process Control in Multi-Step Synthesis of Pharmaceutical Intermediates, identified by its CAS number {cas_number}, plays a vital role in the manufacturing of active pharmaceutical ingredients and their key intermediates. The precise chemical identity of this compound, defined by its molecular formula {molecular_formula} and a molecular weight of {molecular_weight}, ensures reliable process reproducibility within the pharmaceutical industry. For unambiguous reference and traceability in quality control systems, the IUPAC name is {iupac_name}, and its unique InChIKey is {inchikey}. Classified as a pharmaceutical intermediate, this compound bridges multiple synthetic steps that transform starting materials into drug candidates or active ingredients.
A robust understanding of the compound’s physical and chemical profile is central to process optimization. Its melting point is {melting_point}, and it is characterized by a density of {density}. In addition, the flash point is recorded as {flash_point}, supporting risk assessment during handling and storage. Vapor pressure is measured at {vapor_pressure}. These parameters are essential for designing safe and efficient reaction and purification systems in multi-step synthesis.
Global pharmaceutical manufacturers must adhere to rigorous compliance standards in the handling and use of this intermediate. Under the European Union’s REACH regulation, the substance’s registration details are specified by its article number and applicable tonnage band. For companies operating in the United States, TSCA inventory status and section reference confirm regulatory acceptance for industrial use. The compound is also subject to key International Council for Harmonisation (ICH) guidelines, specified by each code and revision, which detail the maximum allowable limits for residuals or impurities. Comprehensive hazard characterization is achieved through the Globally Harmonized System (GHS), with all relevant hazard statements and the prescribed signal word forming part of safe handling procedures. Pharmacopeial standards, supported by explicit chapter references, offer further guidance on quality attributes applicable to pharmaceutical intermediates. Where available, occupational safety data such as OSHA’s permissible exposure limit (PEL) and NIOSH’s recommended exposure limit (REL) inform workplace risk management practices.
Pharmaceutical intermediates like this one are designed for highly specific transformations within drug manufacturing. These molecules are frequently incorporated into synthetic schemes for both established and novel drug candidates. The use index and references from public databases can indicate relevance to several classes of therapeutics, depending on the synthetic stage and structural features of the compound involved. However, it is important to note that while this intermediate contributes to the construction of active compounds, it does not possess direct therapeutic activity and should not be construed as delivering clinical benefit on its own.
Bulk packaging formats that are standard in the pharmaceutical industry are available, including 25-kilogram and 200-kilogram drums, as well as intermediate bulk containers (IBCs), enabling flexible logistics for small-scale development and large-scale manufacturing alike. Based on stability data derived from GHS classification, recommended storage involves keeping the product in tightly sealed containers, protected from moisture, heat extremes, and direct sunlight to ensure quality and stability over time. For this class of intermediates, an industry standard shelf life is typically observed when stored under specified conditions, accommodating the requirements of drug development timelines.
All information provided in this article is supported and can be cross-referenced in key public databases including PubChem at https://pubchem.ncbi.nlm.nih.gov/compound/{cid}, the NIST Chemistry WebBook at https://webbook.nist.gov/cgi/cbook.cgi?Name={cas_number}, ECHA at {echa_url}, and the US EPA TSCA inventory at https://www.epa.gov/tsca-inventory.
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