Methylsulfonylmethane Tablets
» Methylsulfonylmethane Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of methylsulfonylmethane (C2H6O2S).
Packaging and storage
Preserve in tight, light-resistant containers.
Identification
The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Disintegration and dissolution 2040:
meet the requirements for Disintegration only; 30 minutes.
Weight variation 2091:
meet the requirements.
Assay
Diluent, Standard preparation, and Chromatographic system
Proceed as directed in the Assay under Methylsulfonylmethane.
Assay preparation
Weigh and finely powder not fewer than 20 Tablets. Dissolve an accurately weighed portion of the finely powdered material, equivalent to about 1 Tablet, in Diluent, mix, and sonicate for 15 minutes at 50. Allow to cool to room temperature, dilute with Diluent to volume, and mix. Quantitatively dilute with Diluent to obtain a final concentration of 0.4 mg of methylsulfonylmethane per mL. Transfer about 1 mL of the suspension to a 1.5-mL microcentrifuge tube, and centrifuge for 20 seconds. Use the supernatant.
Procedure
Separately inject equal volumes (about 1 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 methylsulfonylmethane (C2H6O2S) in the portion of Tablets taken by the formula:
DC(RU / RS)
in which D is the dilution factor; C is the concentration, in mg per mL, of USP Methylsulfonylmethane RS in the Standard preparation; and RU and RS are the peak response ratios of methylsulfonylmethane to di(ethylene glycol) methyl ether 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 1054
Pharmacopeial Forum: Volume No. 32(3) Page 827
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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