Clindamycin Hydrochloride Oral Solution
» Clindamycin Hydrochloride Oral Solution contains the equivalent of not less than 90.0 percent and not more than 110.0 percent 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 preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Uniformity of dosage units 905
for solution packaged in single-unit containers: meets the requirements.
Deliverable volume 698: meets the requirements.
pH 791: between 2.5 and 6.0.
Mobile phase , Standard preparation, and Chromatographic system—Proceed as directed in the Assay under Clindamycin Hydrochloride.
Assay preparation— Transfer an accurately measured volume of Oral Solution, equivalent to about 85 mg of clindamycin, to a 100-mL volumetric flask, dilute with Mobile phase to volume, and mix.
Procedure— Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the areas for the major peaks. Calculate the quantity, in mg, of clindamycin (C18H33ClN2O5S) in each mL of the Oral Solution taken by the formula:
0.1(CP / V)(rU / rS)
in which C is the concentration, in mg per mL, of USP Clindamycin Hydrochloride RS in the Standard preparation; P is the potency, in µg of clindamycin per mg, of USP Clindamycin Hydrochloride RS; V is the volume, in mL, of Oral Solution taken to prepare the Assay preparation; and rU and rS are the clindamycin peak area responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
(MDANT05) Monograph Development-Antibiotics
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 1968
Pharmacopeial Forum: Volume No. 31(5) Page 1350
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.