Clindamycin Phosphate Topical Suspension
» Clindamycin Phosphate Topical Suspension 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.
USP Reference standards 11
USP Clindamycin Phosphate RS Click to View Structure
USP Clindamycin Hydrochloride RS Click to View Structure
Identification— The retention time of the clindamycin phosphate peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Minimum fill 755: meets the requirements.
pH 791: between 4.5 and 6.5.
Mobile phase , Resolution solution, Standard preparation, and Chromatographic system—Proceed as directed in the Assay under Clindamycin Phosphate Gel.
Assay preparation— Using a suitable hypodermic needle and syringe, transfer an accurately measured volume of Topical Suspension, equivalent to about 20 mg of clindamycin (C18H33ClN2O5S), to a 100-mL volumetric flask, dilute with Mobile phase to volume, and mix.
Procedure— Proceed as directed for Procedure in the Assay under Clindamycin Phosphate Gel. Calculate the quantity, in mg, of clindamycin (C18H33ClN2O5S) in each mL of the Topical Suspension taken by the formula:
0.1(CE / V)(rU / rS)
in which V is the volume, in mL, of Topical Suspension taken, and the other terms are as defined therein.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
Senior Scientific Liaison
(SM12010) Monographs - Small Molecules 1
Reference Standards RS Technical Services
USP35–NF30 Page 2708