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Chlorobutanol Hemihydrate

Specializing in the production of pharmaceutical excipients

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Chlorobutanol Hemihydrate

(CDMF NO.: F20209990112)

Name: Chlorobutanol Hemihydrate

M.F.C4H7Cl3O·1/2H2O

M.W.:186.47

CAS No.6001-64-5

Package: 1kg/bag, 5kg/bag, 25kg/drum

Appearance: 

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: : CP2020 ; USP43-NF38; EP10.0; BP2017; JP17

Application:

Product codeSpecificationDescription
AG0401HemihydrateCP2020; USP43-NF38; EP9.0; BP2017; JP17 
AG0402HemihydrateEP10.0; BP2020Low related substancesLow residual solventsLow endotoxin control
AG0404AnhydrousEP10.0; BP2020

A widely used, very effective preservative in many injectable, eye drops, cosmetic and mouth wash preparations. Typically it is used in 0.5% concentration.  Antifungal and antibacterial, effective against Gram-positive and Gram-negative bacteria and some fungi, such as Candida albicans and Pseudomonas aeruginosa. The antibacterial activity is bacteriostatic rather than bactericidal. When the pH is greater than 5.5, the activity decreases significantly.

Chlorobutanol NF/USP appears in the pharmacopeias of China, Czechoslovakia, Egypt, Hungary, India, Norway, and Yugoslavia as the hemi-hydrate and in Brazil, Mexico and the U.S. in both the anhydrous and hemi-hydrate form. Australia, Great Britain, France, Germany, Italy, Holland, and Switzerland have separate monographs for the anhydrous and hemi-hydrate (up to 6 percent water) forms. Turkey’s pharmacopoeia has only the anhydrous form.

Incompatibility: 

*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.

Storage: 

Preserve in airtight containers.

 

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