Meclocycline Sulfosalicylate Cream
» Meclocycline Sulfosalicylate Cream contains the equivalent of not less than 90.0 percent and not more than 125.0 percent of the labeled amount of meclocycline (C22H21ClN2O8).
Packaging and storage Preserve in tight containers, protected from light.
Minimum fill 755: meets the requirements.
Standard preparation Transfer 36 mg of USP Meclocycline Sulfosalicylate RS, accurately weighed, to a 50-mL volumetric flask, dilute with methanol to volume, and mix. Transfer 2.0 mL of this solution to a 100-mL volumetric flask, dilute with Mobile phase to volume, and mix to obtain a solution having a known concentration of about 10 µg of meclocycline per mL.
Assay preparation Transfer an accurately weighed quantity of Cream, equivalent to about 5 mg of meclocycline, to a glass-stoppered, 50-mL centrifuge tube, add 20 mL of methanol and 20 mL of 0.025 N sulfuric acid, and shake vigorously for 15 minutes. Transfer the solution to a 50-mL volumetric flask, rinsing the centrifuge tube with two 5-mL portions of methanol and adding the rinsings to the flask, dilute with methanol to volume, and mix. Centrifuge a portion of this solution for 5 minutes, transfer 5 mL of the supernatant to a 50-mL volumetric flask, dilute with Mobile phase to volume, mix, and filter.
Procedure Proceed as directed in the Assay under Meclocycline Sulfosalicylate. Calculate the quantity, in mg, of meclocycline (C22H21ClN2O8) in the portion of Cream taken by the formula:
0.5C(rU / rS)in which C is the concentration, in µg per mL, of meclocycline in the Standard preparation; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information Please check for your question in the FAQs before contacting USP.Chromatographic Column
USP32NF27 Page 2860Pharmacopeial Forum: Volume No. 34(3) Page 628
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.