Purity Specifications for Laboratory Reagents in Chemical Manufacturing, identified by its CAS number, is a critical laboratory reagent in the chemical manufacturing sector. Its use ensures consistent quality control, compliance with manufacturing standards, and reliability across analytical and preparative processes. The accurate characterization of this reagent is supported by its molecular formula, molecular weight, IUPAC name, and unique InChIKey, all of which provide unambiguous identification for procurement and regulatory submissions. These details are essential when validating materials for good manufacturing practices and when submitting documentation for international trade or inspection. This compound is classified as a laboratory reagent, which distinguishes it from pharmaceuticals or food additives, highlighting its role primarily within research and industrial synthesis environments.
The physical and chemical specifications of this reagent, including properties such as melting and boiling points, density, flash point, and vapor pressure, are integral to its safe handling and use in laboratory and production facilities. These properties are determined by standardized methods and are frequently referenced to ensure proper storage, compatibility with other substances, and to minimize occupational risks. Compliance with these physical parameters underpins the reagent’s role in enabling accurate and repeated outcomes in chemical synthesis and analysis.
From a regulatory perspective, Purity Specifications for Laboratory Reagents in Chemical Manufacturing is subject to comprehensive evaluation. Its REACH registration status, including the relevant article number and tonnage band, affirms its authorization for use and marketability within the European Union. Placement on the TSCA inventory, alongside the applicable section reference, secures its distribution in the United States and supports compliance during audits or inspections. Any applicable ICH guideline is referenced with its full code and revision, ensuring the reagent meets global standards for purity and impurity limits in pharmaceutical development. The GHS hazard classification details all assigned signal words and H-phrases, guiding end users in implementing required safety measures during storage, transport, and use. The presence of pharmacopeia references, with chapter citations, and exposure limits set by OSHA PEL or NIOSH REL, further reinforce the chemical's alignment with workplace safety and public health norms.
Given its status as a laboratory reagent, this compound plays a vital part in a wide range of chemical syntheses, quality control procedures, and analytical chemistry workflows. While it is not itself a therapeutic agent, it may be utilized in the synthesis of active ingredients or excipients required for pharmaceutical production. Its applications are defined by its functional chemical properties and its place within reaction schemes documented in comprehensive databases. Any suggestion of efficacy or direct association with finished drug products must be avoided, but its contribution as a reagent in multistep synthesis or analytical validation is widely recognized.
Packaging of this laboratory reagent typically follows industry standards to maintain its quality and facilitate safe handling. Common options include 25-kilogram drums for laboratory or pilot-scale use, 200-kilogram drums for larger-scale operations, and intermediate bulk containers (IBCs) for bulk applications in continuous manufacturing. Storage recommendations are derived from GHS stability data, ensuring that the chemical is protected from light, moisture, and temperature extremes in well-ventilated, designated storage areas. Industry guidelines recommend a shelf life consistent with the stability of this particular class of laboratory reagents, allowing confidence in longevity without compromising purity or performance.
All technical and regulatory information is sourced from authoritative databases and agencies, including PubChem, NIST, ECHA, and the EPA’s TSCA inventory, to guarantee accuracy and up-to-date coverage of international compliance requirements.
Sources
PubChem: https://pubchem.ncbi.nlm.nih.gov/compound/{cid}
NIST: https://webbook.nist.gov/cgi/cbook.cgi?Name={cas_number}
ECHA: {echa_url}
EPA TSCA: https://www.epa.gov/tsca-inventory
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