» Clindamycin Injection contains an amount of Clindamycin Phosphate in Water for Injection equivalent to not less than 90.0 percent and not more than 120.0 percent of the labeled amount of clindamycin (C18H33ClN2O5S). It may be frozen.
Packaging and storage Preserve in single-dose or multiple-dose containers, preferably of Type I glass, or in suitable plastic containers.
Labeling It meets the requirement for Labeling under Injections 1. Where it is maintained in the frozen state, the label states that it is to be thawed just prior to use, describes the conditions for proper storage of the resultant solution, and directs that the solution is not to be refrozen.
Identification The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that of the Standard preparation as obtained in the Assay.
Bacterial endotoxins 85 It contains not more than 0.58 USP Endotoxin Unit per mg of clindamycin.
pH 791: between 5.5 and 7.0.
Particulate matter 788: meets the requirements for small-volume injections.
Other requirements It meets the requirements under Injections 1.
Mobile phase Dissolve 10.54 g of monobasic potassium phosphate in 775 mL of water, and adjust with phosphoric acid to a pH of 2.5. Add 225 mL of acetonitrile, mix, and filter. Make adjustments if necessary (see System Suitability under Chromatography 621). [noteEnsure that the concentration of acetonitrile in the Mobile phase is not less than 22% and not more than 25% in order to retain the correct elution order.]
Standard preparation Dissolve an accurately weighed quantity of USP Clindamycin Phosphate RS in Mobile phase to obtain a solution having a known concentration of about 0.24 mg per mL.
Assay preparation Transfer an accurately measured volume of Injection, equivalent to about 300 mg of clindamycin, to a 100-mL volumetric flask, dilute with Mobile phase to volume, and mix. Transfer 7.0 mL of the resulting solution to a 100-mL volumetric flask, dilute with Mobile phase to volume, and mix.
Resolution solution Prepare a solution of USP Benzyl Alcohol RS in Mobile phase to obtain a solution having a concentration of about 0.1 mg per mL. Add about 25 mL of this solution to a 100-mL volumetric flask containing about 25 mg of USP Clindamycin Phosphate RS, dilute with Mobile phase to volume, and mix.
Chromatographic system (see Chromatography 621) The liquid chromatograph is equipped with a 210-nm detector and a 4.6-mm × 25-cm column that contains packing L7. The flow rate is about 1 mL per minute. Chromatograph the Resolution solution, and record the peak responses as directed for Procedure: the relative retention times are 1.0 for clindamycin phosphate and about 1.2 for benzyl alcohol; and the resolution, R, between clindamycin phosphate and benzyl alcohol is not less than 2.0. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the relative standard deviation for replicate injections is not more than 2.5%.
Procedure Separately inject equal volumes (about 20 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of clindamycin (C18H33ClN2O5S) in each mL of the Injection taken by the formula:
(10/7)(CP/V)(rU / rS)in which C is the concentration, in mg per mL, of USP Clindamycin Phosphate RS in the Standard preparation; P is the potency, in µg of C18H33ClN2O5S per mg, of USP Clindamycin Phosphate RS; V is the volume, in mL, of Injection taken; and rU and rS are the clindamycin phosphate peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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USP32NF27 Page 1971Pharmacopeial Forum: Volume No. 30(5) Page 1597