(CDMF NO.: F20209990112)
Name: Chlorobutanol Hemihydrate
White crystal powder; it has special odor resembling camphor; Easy to sublimate. Soluble in ethanol, chloroform, ether or volatile oil, slightly soluble in water.
Quality Standard: CHP 2015 ; USP40-NF35; EP9.0; BP2017; JP17
*Used as a preservative in pharmaceuticals, the commonly used concentration is 0.5% (W/V).
*Antifungal and antibacterial, effective against Gram-positive and Gram-negative bacteria and some fungi, such as Candida albicans and Pseudomonas aeruginosa.
*Widely used as preservatives in ophthalmic preparations, and especially suitable for non-aqueous preparations.
*The antibacterial activity is bacteriostatic rather than bactericidal. When the pH is greater than 5.5, the activity decreases significantly.
*It is acidic and incompatibility with alkaline drugs, menthol, antipyrine, phenol, thymol, etc.
*Due to its adsorption problem, Chlorobutanol is incompatible with plastic vials, rubber stoppers, bentonite, magnesium trisiloxane, polyethylene, and polyhydroxy ethyl methacrylate used for contact lenses.
*Carboxymethyl cellulose and non-ionic surfactants such as Twain 80 will also reduce its antibacterial and antiseptic activity.
Safety: Although animal experiments have shown that this product may be harmful to the eyes, in practice, Chlorobutanol is commonly used as an antibacterial agent in ophthalmic preparations and there are very few adverse reactions reported.
Preserve in airtight containers.