Clindamycin Hydrochloride Oral Solution
»Clindamycin Hydrochloride Oral Solution contains the equivalent of not less than 90.0percent and not more than 110.0percent of the labeled amount of clindamycin (C18H33ClN2O5S).
Packaging and storage— Preserve in tight containers.
Labeling— Label Oral Solution to indicate that it is intended for veterinary use only.
Identification— The retention time of the clindamycin peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.
Uniformity of dosage units á905ñ—
FOR SOLUTION PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.
Deliverable volume á698ñ: meets the requirements.
pHá791ñ: between 3.0and 5.5.
Assay—
Mobile phase ,Standard preparation,and Chromatographic system—Proceed as directed in the Assayunder Clindamycin Hydrochloride.
Assay preparation— Transfer an accurately measured volume of Oral Solution,equivalent to about 85mg of clindamycin,to a 100-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.
Procedure— Separately inject equal volumes (about 10µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the areas for the major peaks.Calculate the quantity,in mg,of clindamycin (C18H33ClN2O5S)in each mLof the Oral Solution taken by the formula:
0.1(CP/V)(rU/rS),
in which Cis the concentration,in mg per mL,of USP Clindamycin Hydrochloride RSin the Standard preparation;Pis the potency,in µg of clindamycin per mg,of USP Clindamycin Hydrochloride RS;Vis the volume,in mL,of Oral Solution taken to prepare the Assay preparation;and rUand rSare the clindamycin peak area responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 494
Phone Number:1-301-816-8335