Simethicone Tablets
» 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.
Identification, Infrared Absorption 197S [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; 60 minutes for plain-coated Tablets; and 45 minutes for Tablets labeled as gelatin-coated, simulated gastric fluid being used as the medium.
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 [–(CH3)2SiO–]n in the portion of Tablets taken by the formula:
25C(AU / AS)
in which C is the concentration, in mg per mL, of USP Polydimethylsiloxane RS in the Standard solution, and AU and AS are the absorbances of the solution from the Tablets and the Standard solution, respectively.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Elena Gonikberg, Ph.D.
Senior Scientist
(MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine
Reference Standards Lili Wang, Technical Services Scientist
701 Margareth R.C. Marques, Ph.D.
Senior Scientist
(BPC05) Biopharmaceutics05
USP32–NF27 Page 3556
Pharmacopeial Forum: Volume No. 34(3) Page 652