Simethicone Oral Suspension
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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 Oral Suspension is a suspension of Simethicone in Water. It contains 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: Meets the requirements
3 ASSAY
PROCEDURE
Standard solution: 2.4 mg/mL of USP Poly dimethylsiloxane RS, prepared as follows. Transfer 60 mg of USP Poly dimethylsiloxane RS to a 25- mL volumetric flask, add 15 mL of hexanes, and sonicate for 3 min. Allow to cool, dilute with hexanes to volume, and mix. Transfer 10 mL of this solution to a capped test tube, add 1 g of anhydrous sodium sulfate, mix for about 1 min, centrifuge, and use the clear supernatant.
Sample solution: Transfer an quantity of Oral Suspension, equivalent to about 240 mg of simethicone, to a glass-stoppered centrifuge tube. Add 5 mL of methanol, and mix for about 15 s. Add 30.0 mL of hexanes, and mix for about 10 s. Loosen the stopper, and heat the tube for about 10 min in a water bath at 65° ± 1°. Mix for 1 min, and centrifuge. Using a glass syringe, transfer the upper hexanes layer to a 100-mL volumetric flask. Repeat the extraction with two 30.0-mL portions of hexanes, combining the hexanes extracts in the 100-mL volumetric flask. If an emulsion forms during any of the extractions, as much as 2 mL of methanol may be added to disperse the emulsion. Allow the combined extracts to cool, dilute with hexanes to volume, and mix. Transfer 10 mL of this solution to a capped test tube, add 1 g of anhydrous sodium sulfate, mix for 1 min, centrifuge, and use the clear supernatant.
Blank: Mix 100 mL of hexanes and 10 g of anhydrous sodium sulfate, allow to settle, centrifuge, and use the clear supernatant.
Analysis
Samples: Standard solution and Sample solution
Concomitantly determine the absorbances of the Standard solution and the Sample solution 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 portion of the Oral Suspension taken:
Result = (AU/AS) × (CS/CU) × 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)
CU = nominal concentration of simethicone in the Sample solution (mg/mL)
Acceptance criteria: 85.0%–115.0%
4 SPECIFIC TESTS
PH 〈791〉: 3.5–4.6
5 ADDITIONAL REQUIREMENTS
PACKAGING AND STORAGE: Preserve in tight, light-resistant containers.
USP REFERENCE STANDARDS 〈11〉
USP Polydimethylsiloxane RS
