Parenteral and Oral Dosage Formulation Processes for Pharmaceutical Preservatives are essential to the pharmaceutical manufacturing sector, ensuring the stability and safety of both injectable and oral medications. This product, identified for regulatory tracking under its unique CAS number, is typically specified by its molecular formula, precise molecular weight, and supported by definitive identifiers such as its International Union of Pure and Applied Chemistry (IUPAC) name and InChIKey. These identifiers allow for unequivocal recognition and traceability within both chemical inventories and regulatory submissions. The product serves as a pharmaceutical excipient, providing necessary antimicrobial protection within medicinal formulations.
The detailed physical and chemical properties of this substance are critical to its reliable performance in drug manufacturing. Data relating to melting and boiling points, density, flash point, and vapor pressure—when available—help guide both formulation design and safe handling. These parameters are fundamental for selecting appropriate process conditions, for example, ensuring the stability and homogeneity of preservative solutions in liquid dosages or controlling conditions during sterilization and compounding.
Adherence to regulatory standards is a cornerstone for this preservative’s use in parenteral and oral dosage forms. The product’s registration status under REACH is referenced by its article number and designated tonnage band, providing transparency and compliance for manufacturers operating in the European Union. Within the United States, inclusion on the Toxic Substances Control Act (TSCA) Chemical Substance Inventory is noted by its relevant section, confirming statutory acceptance for commercial use. When applicable, International Council for Harmonisation (ICH) guidelines are cited by their full code and revision, specifying permitted limits of residual solvent or impurity content, and reflecting harmonized pharmaceutical quality requirements. The Globally Harmonized System (GHS) of Classification and Labelling of Chemicals describes all assigned hazard statements with the required signal word, highlighting areas such as flammability, toxicity, or irritancy. Any references in major pharmacopeial compendia, with precise chapter numbers, indicate further recognition or guidance on use in drug products. For occupational health, official exposure limits published by OSHA or NIOSH are included when available, supporting a safe working environment during handling and formulation.
As a well-established excipient, the product finds application in the formulation of both parenteral and oral medicines, acting to inhibit microbial growth and maintain product integrity throughout shelf life. It supports compliance with pharmaceutical standards for dosage forms such as aqueous injections, oral liquids, and reconstitutable powders. Its utility in formulation development is especially valuable where process sterility and multi-dose packaging are required, although it is not itself an active pharmaceutical ingredient and does not confer therapeutic efficacy.
Packaging solutions for this class of preservative generally include standard drums and intermediate bulk containers suitable for high-purity excipients, with sizes commonly ranging from 25 kilograms up to larger industrial volumes. Recommended storage conditions are dictated by the product’s stability and reactivity, as reflected in the GHS hazard and stability classification, typically advocating for cool, well-ventilated, and dry environments, away from sources of ignition or incompatible substances. Shelf life guidance is consistent with industry standards for pharmaceutical excipients, supporting extended storage under controlled conditions when proper packaging is maintained.
Further information and supporting documentation on this preservative for pharmaceutical applications, including its chemical profile and regulatory details, can be sourced from the following resources: PubChem at pubchem.ncbi.nlm.nih.gov, NIST Chemistry WebBook, the ECHA database, and the United States Environmental Protection Agency TSCA Inventory.
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