Process Design for Pharmaceutical API Intermediate Synthesis offers a specialized solution for the synthesis of advanced pharmaceutical intermediates. Identified by its unique CAS number, this compound is typically detailed with its molecular formula and molecular weight, facilitating precise tracking and sourcing for R&D and production purposes. The substance is further defined by its IUPAC name and InChIKey, ensuring clear and unambiguous identification in scientific records. Within pharmaceutical chemistry, it is classified as an intermediate, underscoring its central role in constructing active pharmaceutical ingredients prior to their final API form.
The physical and chemical characteristics of this intermediate are critical to its performance in process design. Key specifications commonly reported for such substances include boiling point, melting point, density, flash point, and vapor pressure. The presence or absence of each property helps guide process optimization, selection of reaction conditions, and safe handling protocols in both laboratory and industrial settings. This careful characterization supports robust process development and reproducibility for API manufacturing.
From a regulatory and compliance perspective, the intermediate’s legal status under REACH is described with its relevant article reference and tonnage band, providing purchasers with clear guidance on its permitted uses and obligations within the European Economic Area. For the United States, the TSCA inventory status and section reference are essential for confirming its legal commercial status domestically. Where applicable, compliance with ICH guidelines is stated with full section code and most recent revision, as well as any specific impurity limits or requirements that may apply. Hazard information is communicated according to the Globally Harmonized System, covering all relevant H-statements and the assigned signal word, alerting users to its risk profile and the need for proper protection. If the intermediate is recognized by any pharmacopeia, appropriate chapters are cited. Additionally, established worker safety guidelines from OSHA and NIOSH are included if they are available, providing occupational exposure limits.
This compound finds its primary use as an intermediate in pharmaceutical synthesis, functioning as a building block in the complex, multi-step production of final APIs. Its role in these synthetic pathways enables chemists to construct molecules with the required purity and structural attributes for downstream transformation into market-ready drugs. Reference to the PubChem use index, as well as peer-reviewed synthesis routes, can identify specific drugs or classes in which this intermediate is regularly utilized, offering further insight into its practical significance in modern pharmaceutical manufacturing. The use of this compound is confined to synthesis and does not imply any direct therapeutic efficacy.
In terms of packaging and storage, industry standards usually favor formats such as 25 kilogram drums, 200 kilogram drums, or intermediate bulk containers, depending on the scale of the user's operation. Storage recommendations are informed by the compound’s GHS stability data, as well as general best practices for organic intermediates—typically calling for a cool, well-ventilated environment away from sources of ignition or incompatible materials. Shelf life guidance adheres to industry norms for the class, ensuring material quality is maintained up to the point of use.
All details and specifications referenced herein are based on authoritative sources, including PubChem, the NIST Chemistry WebBook, the European Chemicals Agency portal, and the US EPA TSCA Chemical Inventory. For further reading and verification, the following resources are recommended: https://pubchem.ncbi.nlm.nih.gov/compound/, https://webbook.nist.gov/cgi/cbook.cgi?Name=, https://echa.europa.eu/, and https://www.epa.gov/tsca-inventory.
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