Simethicone Capsules
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
1 DEFINITION
Simethicone Capsules contain an amount of polydimethylsiloxane ([–(CH3)2SiO–]n) that is NLT 85.0% and NMT 115.0% of the labeled amount of simethicone.
2 IDENTIFICATION
Change to read:
A. SPECTROSCOPIC IDENTIFICATION TESTS 〈197〉 , Infrared Spectroscopy : 197S (CN 1-M -2020)
Standard solution, Sample solution, and Blank: Prepare as directed in the Assay. Cell: 0.5 mm
Acceptance criteria: Meet the requirements
3 ASSAY
PROCEDURE
Perform this procedure on at least 3 individual Capsules. The mean of the assay values obtained is the assay value.
Standard solution: Prepare similarly to the Sample solution, except use 2.5 mg/mL of USP Polydimethylsiloxane RS in toluene.
Sample solution: Transfer 1 Capsule to a round, narrow-mouth, screw-capped, 120-mL bottle. Add 20 mL of 6 N hydrochloric acid, and allow to stand, with frequent swirling, until the Capsule has dissolved. Add 10.0 mL of toluene for each 25 mg of the labeled amount of simethicone in the Capsule, close the bottle securely with a cap having an inert liner, and shake by mechanical means for 5 min. Allow the phases to separate, draw off 10 mL of the upper organic (toluene) layer to a test tube containing 0.5 g of anhydrous sodium sulfate, agitate vigorously for 30 s, and allow the mixture to settle. If necessary, centrifuge the mixture to obtain a clear solution.
Blank: Prepare similarly to the Sample solution, except use 10 mL of toluene. Analysis
Samples: Standard solution and Sample solution
Concomitantly determine the absorbances of the Standard solution and the Sample solution in 0.5-mm cells at the wavelength of maximum absorbance at about 7.9 µm, with a suitable IR spectrophotometer, using the Blank to set the instrument.
Calculate the percentage of polydimethylsiloxane ([–(CH3)2SiO–]n) in the Capsule taken:
Result = (AU/AS) × CS × V × (1/L) × 100
AU = absorbance of the Sample solution
AS = absorbance of the Standard solution
CS = concentration of USP Polydimethylsiloxane RS in the Standard solution (mg/mL)
V = volume of toluene used to prepare the Sample solution (mL)
L = labeled amount of simethicone (mg/Capsule)
Acceptance criteria: 85.0%–115.0%
4 PERFORMANCE TESTS
DISINTEGRATION 〈701〉
For hard gelatin capsules
Time: 30 min, determined using water For soft gelatin capsules
Time: 30 min, determined using 1.0% octoxynol-9 (w/w) in water, using disks
Acceptance criteria: Meet the requirements
UNIFORMITY OF DOSAGE UNITS 〈905〉: Meet the requirements
5 ADDITIONAL REQUIREMENTS
PACKAGING AND STORAGE: Preserve in well-closed containers.
USP REFERENCE STANDARDS 〈11〉
USP Polydimethylsiloxane RS
