Simethicone Tablets
If you find any inaccurate information, please let us know by providing your feedback here
This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
Simethicone Tablets contain an amount of polydimethylsiloxane ([–(CH3)2SiO–]n) that is not less than 85.0 percent and not more than 115.0 percent of the labeled amount of simethicone.
Packaging and storage—Preserve in well-closed containers. Labeling—Tablets that are gelatin-coated are so labeled.
USP REFERENCE STANDARDS 〈11〉—
USP Polydimethylsiloxane RS
Change to read:
Identification,Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy : 197S (CN 1-May-2020)
[NOTE—Use the procedural blank, prepared as directed in the Assay, to set the instrument.] Test solution—Prepare as directed for the Assay preparation in the Assay.
Standard solution—Prepare as directed for the Standard preparation in the Assay. Cell size: 0.5 mm.
DISINTEGRATION 〈701〉: 30 minutes in water; 60 minutes in water for plain-coated Tablets; and 45 minutes in simulated gastric fluid for Tablets
labeled as gelatin-coated.
UNIFORMITY OF DOSAGE UNITS 〈905〉: meet the requirements.
Assay—Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 50 mg of simethicone, to a round, narrow-mouth, screw-capped, 120-mL bottle, and proceed as directed in the Assay under Simethicone, beginning with “add 25.0 mL of toluene,” except that for Tablets labeled as gelatin-coated, shake for 30 minutes instead of 5 minutes. Calculate the quantity, in mg, of [–(CH ) SiO–] in the portion of Tablets taken by the formula:
25C(AU/AS)
in which C is the concentration, in mg per mL, of USP Poly dimethylsiloxane RS in the Standard solution, and A and A are the absorbances of the solution from the Tablets and the Standard solution, respectively.
