Methylsulfonylmethane Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of methylsulfonylmethane (C2H6O2S).
• A. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Procedure for Strength.
Diluent: Transfer 950 mL of methanol to a 1-L volumetric flask. Add 0.60 mL of diethylene glycol methyl ether, and dilute with methanol to volume.
Standard solution: 0.4 mg/mL of USP Methylsulfonylmethane RS in Diluent. Sonicate at 50 for 1 min, and allow to cool to room temperature.
Sample solution: Finely powder NLT 20 Tablets. Dissolve a portion of the finely powdered material, equivalent to 1 Tablet, in Diluent, and sonicate for 15 min 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/mL of methylsulfonylmethane. Transfer 1 mL of the suspension to a 1.5-mL microcentrifuge tube, and centrifuge for 20 s. Use the supernatant.
Detector: Flame ionization
Column: 0.53-mm × 30-m capillary; 5-µm phase G2 coating
Carrier gas: Helium
Flow rate: 5 mL/min
Injection size: 1 µL
Injector type: Split ratio, 2:1
Sample: Standard solution
Relative standard deviation: NMT 2.0% for the peak response ratio of methylsulfonylmethane to diethylene glycol methyl ether from replicate injections
Samples: Standard solution and Sample solution
Calculate the percentage of the labeled amountof of methylsulfonylmethane (C2H6O2S) in the portion of Tablets taken:
Result = (RU/RS) × (CS/CU) × 100
Acceptance criteria: 90.0%110.0%
• Disintegration and Dissolution 2040: Meet the requirements for Disintegration; 30 min
• Weight Variation 2091: Meet the requirements
• Packaging and Storage: Preserve in tight, light-resistant containers.
• USP Reference Standards 11
USP Methylsulfonylmethane RS
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USP35NF30 Page 1384Pharmacopeial Forum: Volume No. 32(3) Page 827