Methylsulfonylmethane Tablets
DEFINITION
Methylsulfonylmethane Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of methylsulfonylmethane (C2H6O2S).
IDENTIFICATION
•  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.
STRENGTH
•  Procedure
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.
Chromatographic system 
Mode:  GC
Detector:  Flame ionization
Column:  0.53-mm × 30-m capillary; 5-µm phase G2 coating
Temperature 
Column:  120
Injector:  250
Detector:  250
Carrier gas:  Helium
Flow rate:  5 mL/min
Injection size:  1 µL
Injector type:  Split ratio, 2:1
System suitability 
Sample:  Standard solution
Suitability requirements 
Relative standard deviation:  NMT 2.0% for the peak response ratio of methylsulfonylmethane to diethylene glycol methyl ether from replicate injections
Analysis 
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
RU== internal standard ratio (peak response of methylsulfonylmethane to diethylene glycol methyl ether) from the Sample solution
RS== internal standard ratio (peak response of methylsulfonylmethane to diethylene glycol methyl ether) from the Standard solution
CS== concentration of USP Methylsulfonylmethane RS in the Standard solution (mg/mL)
CU== nominal concentration of methylsulfonylmethane in the Sample solution (mg/mL)
Acceptance criteria:  90.0%–110.0%
PERFORMANCE TESTS
•  Disintegration and Dissolution 2040: Meet the requirements for Disintegration; 30 min
•  Weight Variation 2091: Meet the requirements
ADDITIONAL REQUIREMENTS
•  Packaging and Storage: Preserve in tight, light-resistant containers.
•  USP Reference Standards 11
USP Methylsulfonylmethane RS
Dimethyl sulfone.
    C2H6O2S        94.13
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Natalia Davydova
Scientific Liaison
1-301-816-8328
(DS2010) Monographs - Dietary Supplements
Reference Standards RS Technical Services
1-301-816-8129
rstech@usp.org
USP35–NF30 Page 1384
Pharmacopeial Forum: Volume No. 32(3) Page 827