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
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.
USP35NF30 Page 1384
Pharmacopeial Forum: Volume No. 32(3) Page 827
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