Chlorobutanol hemihydrate – Antimicrobial preservative for high-grade sterile pharmaceutical formulations

1. General introduction to Chlorobutanol hemihydrate

Chlorobutanol hemihydrate is an antimicrobial preservative specifically designed for sterile pharmaceutical formulations, such as ophthalmic drops and injectable solutions. With its ability to inhibit a broad spectrum of microorganisms and fungi, Chlorobutanol hemihydrate plays a pivotal role in maintaining sterility throughout the shelf life and use of the preparation.

In high-grade pharmaceutical manufacturing, Chlorobutanol hemihydrate is not merely a preservative but a strategic excipient that helps maintain sterility, enhance stability, and satisfy rigorous testing standards. Its balance between antimicrobial efficacy and compatibility with various active ingredients makes it particularly suitable for sensitive APIs.

2. Detailed Material Information

• Material name:Chlorobutanol hemihydrate
• Molecular formula:C₄H₇Cl₃O·1/2H₂O
• Physical state: White or colorless crystals, volatile
• Odor and taste: Characteristic odor, camphor-like
• Solubility: Freely soluble in ethanol (95%), acetone, methanol, glycerin, and volatile oils. Sparingly soluble in water, but freely soluble in hot water.
• Stability: Most stable at about pH 3; however, stability decreases as pH increases.
• Incompatibilities: Can be adsorbed by plastic containers, rubber stoppers, bentonite, magnesium trisilicate, and polyhydroxyethylmethacrylate (HEMA). Antimicrobial activity may be reduced when combined with carboxymethyl cellulose (CMC) or polysorbate 80.
• Antimicrobial activity: Demonstrates antimicrobial activity at pH below 5.5. Commonly used at a concentration of 0.25–0.5% w/v.
• Quality standards: Complies with international pharmacopoeias (USP/NF, EP, JP, ChP).

3. Advantages of Chlorobutanol hemihydrate

• Broad-spectrum antimicrobial efficacy:Inhibits Gram-positive and Gram-negative bacteria as well as mold, including common fungal and yeast strains such as Candida albicans, Pseudomonas aeruginosa, and Staphylococcus albus.
• Due to its solubility in organic solvents and oils, Chlorobutanol hemihydrate serves as an ideal antibacterial and antifungal solution for nonaqueous formulations, such as oily injectables, ointments, creams, emulsions, and ophthalmic drops
• Chlorobutanol exhibits outstanding physicochemical stability and excellent compatibility withAPIs that are soluble in or stable underacidic conditions, such as Oxytocin and Vitamin A Palmitate.

4. Applications of Chlorobutanol hemihydrate

Chlorobutanol hemihydrate is widely used across multiple dosage forms due to its stabilizing and antimicrobial properties:

• Chlorobutanol is widely used as a broad-spectrum antimicrobial preservative, providing effective protection against bacterial and fungal contamination in ophthalmic drops and multiple-dose injections.
• As a plasticizer, Chlorobutanol improves the mechanical strength of polymeric film coatings and minimizes film cracking in coatings based on cellulose ester and cellulose ether derivatives for film-coated tablets.

5. Commercial products using Chlorobutanol hemihydrate

6. Product contact information

For more information aboutChlorobutanol hemihydrate supply, please contact us:

• Hotline: +84 (0) 834 560 500
• Email: director@biorichgroup.com
• Website: www.biorichgroup.com
• Sample / COA request:Please contact us via email to receive product samples and the latest Certificate of Analysis (COA).