Pharmaceutical Intermediate Synthesis in Bulk Chemical Manufacturing, identified by the CAS number provided, occupies a vital role within the chemical supply chain for active pharmaceutical ingredient production. Its molecular formula and molecular weight establish its identity and support reliable sourcing. The compound is further defined by its IUPAC name and InChIKey, which provide global standards for unambiguous chemical identification essential in regulatory documentation and quality management. Functionally, this compound is classified as a pharmaceutical intermediate, utilized in the synthesis of active ingredients but not itself a finished drug product.
Specifications for this intermediate encompass several key physical and chemical properties that guide its use and handling requirements. These include the boiling point, melting point, density, flash point, and vapor pressure, where such details are available from recognized data repositories. Each property is critical to process engineers and supply chain personnel, supporting safe processing at scale, controlling for purity, and ensuring compliance with regulatory best practices.
On the regulatory and compliance front, this pharmaceutical intermediate is subject to a robust framework in multiple jurisdictions. Registration under the EU’s REACH regulation is referenced by the applicable article number and the relevant annual tonnage band, signifying proper volume declarations and safety dossier submission. United States requirements are governed by TSCA inventory inclusion, with documentation based on the corresponding section. International Conference on Harmonisation (ICH) guidelines, such as ICH Q3C(R8), apply to the limits of residual solvents in pharmaceutical intermediates, reflecting the latest revision and specifying permissible exposure levels where relevant. The Global Harmonised System (GHS) classification is reflected in hazard statements, labeling requirements, and the designated signal word for safe handling. Where available, pharmacopeial chapters reference compendial standards for quality, while worker safety considerations such as OSHA Permissible Exposure Limits (PEL) or NIOSH Recommended Exposure Limits (REL) may apply.
The primary application of this compound is as an intermediate in the synthesis of specific pharmaceuticals. Its role is integral to multi-step organic syntheses, often serving as a building block or precursor within targeted synthetic routes. While the identity of the final drug products may vary according to the manufacturer’s process, the intermediate’s function is to enable efficient, scalable, and regulatory-compliant production lines. No claims are made regarding direct therapeutic efficacy, as its use is solely as a manufacturing input.
In global supply chains, packaging and storage of pharmaceutical intermediates must adhere to industry best practices for both safety and efficiency. Typically, shipments are managed in 25-kilogram fiber drums, 200-kilogram steel drums, or intermediate bulk containers (IBCs) meeting international transport and warehousing standards. Storage conditions are determined by GHS-stipulated stability data and the material’s inherent characteristics, commonly requiring cool, dry, and well-ventilated premises away from incompatible materials. The standard shelf life for chemicals in this class reflects industry norms and should be verified during procurement to ensure consistent quality.
The information presented here derives from public and regulatory sources, including PubChem, the NIST Chemistry WebBook, the European Chemicals Agency, and the EPA TSCA Inventory. These resources provide current, evidence-based data to inform safe, compliant, and cost-effective use of pharmaceutical intermediates throughout the industry. Sources for this content include PubChem at https://pubchem.ncbi.nlm.nih.gov/compound/{cid}, NIST at https://webbook.nist.gov/cgi/cbook.cgi?Name={cas_number}, the European Chemicals Agency, and the EPA TSCA Inventory at https://www.epa.gov/tsca-inventory.
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