Chloramphenicol Tablets
»Chloramphenicol Tablets contain 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 Tablets to indicate that they are for veterinary use only and are not to be used in animals raised for food production.
Identification— The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparationas obtained in the Assay.
Uniformity of dosage units á905ñ: meet the requirements.
Assay—
Mobile phase and Chromatographic system—Proceed as directed in the Assayunder Chloramphenicol.
Standard preparation— Transfer about 25mg of USP Chloramphenicol RS,accurately weighed,to a 200-mLvolumetric flask,add 10mLof water,and heat on a steam bath until completely dissolved.Cool to room temperature,dilute with Mobile phaseto volume,and mix.Filter a portion of this solution through a 0.5-µm or finer porosity filter,and use the clear filtrate as the Standard preparation.
Assay preparation— Weigh and finely powder not less than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 500mg of chloramphenicol,to a 200-mLvolumetric flask,add 80mLof water,and heat on a steam bath for 20minutes,with occasional mixing.Cool to room temperature,dilute with water to volume,and mix.Transfer 5.0mLof the resulting solution to a 100-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.Filter a portion of this solution through a 0.5-µm or finer porosity filter,and use the clear filtrate as the Assay preparation.
Procedure— Proceed as directed for Procedurein the Assayunder Chloramphenicol.Calculate the quantity,in mg,of C11H12Cl2N2O5in the portion of Tablets taken by the formula:
4C(rU/rS),
in which the terms are as defined therein.
Auxiliary Information— Staff Liaison:Ian DeVeau,Ph.D.,Senior Scientist
Expert Committee:(VET)Veterinary Drugs
USP28–NF23Page 430
Phone Number:1-301-816-8178