1,1,1-Trichloro-2-methyl-2-propanol hemihydrate is a hydrated form of 1,1,1-trichloro-2-methyl-2-propanol, commonly known as chlorobutanol. This compound includes half a mole of water per mole of chlorobutanol, which influences its physical and chemical properties, including stability and solubility. The hemihydrate form is often encountered in pharmaceutical and industrial contexts where controlled hydration is important for handling and formulation.
The parent compound, chlorobutanol, was first characterized in the early 20th century as part of the search for effective antimicrobial and preservative agents. It is a chlorinated tertiary alcohol known for its broad-spectrum antimicrobial activity, including bacteriostatic and fungistatic effects. The hemihydrate form maintains these properties while providing enhanced physical stability and ease of storage compared to the anhydrous form.
1,1,1-Trichloro-2-methyl-2-propanol hemihydrate is primarily utilized as a preservative in pharmaceutical products, especially in multi-dose vials, ophthalmic solutions, and injectable formulations. Its antimicrobial efficacy helps prevent contamination by bacteria, fungi, and yeasts during product use and storage. This is critical in maintaining the sterility and safety of medications, particularly those intended for sensitive routes of administration such as the eyes or injections.
In addition to its role as a preservative, chlorobutanol hemihydrate exhibits local anesthetic properties, which can reduce discomfort upon administration of certain topical or ophthalmic products. This dual functionality as both preservative and mild anesthetic adds to its value in pharmaceutical formulations.
The chemical stability of the hemihydrate form is favorable under typical storage conditions. The presence of water molecules in the crystal lattice can improve handling characteristics and reduce the risk of decomposition compared to the anhydrous counterpart. However, it remains sensitive to strong acids and bases, which can lead to degradation; thus, formulation pH is carefully controlled to preserve its efficacy.
In cosmetic and personal care products, chlorobutanol hemihydrate is sometimes used as a preservative to inhibit microbial growth and prolong product shelf life. Its compatibility with a variety of ingredients and relatively low toxicity make it suitable for inclusion in creams, lotions, and other topical applications.
Safety evaluations indicate that chlorobutanol hemihydrate has low toxicity when used at recommended concentrations. It is generally non-irritating and non-sensitizing in typical applications, although higher concentrations or prolonged exposure may cause local irritation. Regulatory standards limit its concentration in consumer products to ensure safe use.
In summary, 1,1,1-trichloro-2-methyl-2-propanol hemihydrate is a hydrated form of chlorobutanol developed for enhanced stability and handling in pharmaceutical and cosmetic applications. It serves primarily as an antimicrobial preservative and mild local anesthetic, maintaining product sterility and user comfort. Its chemical and biological properties have established it as a reliable ingredient in formulations requiring effective microbial control and safety.
References
2023. UK Veterinary Medicines Directorate's List (S104).
UKVETMED
DOI: 10.5281/zenodo.7802119
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