Chloramphenicol Oral Solution, chemical structure, molecular formula, Reference Standards

Chloramphenicol Oral Solution

»Chloramphenicol Oral Solution is a solution of Chloramphenicol in a suitable solvent.It contains one or more suitable buffers and preservatives.It has a potency of not less than 90.0percent and not more than 120.0percent of the labeled amount of C11H12Cl2N2O5.

Packaging and storage— Preserve in tight containers.

Labeling— Label it to indicate that it is for veterinary use only and that it is not to be used in animals raised for food production.

USP Reference standards á11ñ— USP Chloramphenicol RS.

Identification— Avolume of Oral Solution,equivalent to about 250mg of chloramphenicol,responds to the Identificationtest under Chloramphenicol Capsules.

pHá791ñ: between 5.0and 8.5,when diluted with an equal volume of water.

Assay— Proceed as directed under Antibiotics—Microbial Assays á81ñ,using an accurately measured volume of Oral Solution diluted quantitatively and stepwise with water to yield a Test Dilutionhaving a concentration assumed to be equal to the median dose level of the Standard.

Auxiliary Information— Staff Liaison:Ian DeVeau,Ph.D.,Senior Scientist

Expert Committee:(VET)Veterinary Drugs

USP28–NF23Page 429

Phone Number:1-301-816-8178