Simethicone Tablets
»Simethicone Tablets contain an amount of polydimethylsiloxane ([-(CH3)2SiO-]n)that is not less than 85.0percent and not more than 115.0percent of the labeled amount of simethicone.
Packaging and storage— Preserve in well-closed containers.
Labeling— Tablets that are gelatin-coated are so labeled.
Identification— Tablets respond to the Identificationtest under Simethicone.
Disintegration á701ñ: 30minutes;60minutes for plain coated Tablets;and 45minutes for Tablets labeled as gelatin-coated,simulated gastric fluid being used as the medium.
Uniformity of dosage units á905ñ: meet the requirements.
Defoaming activity—
Foaming solution— Dissolve 500µg of FD&C Blue No.1and 1g of octoxynol 9in 100mLof water,except that where the Tablets are labeled as gelatin-coated,use 0.1Nhydrochloric acid instead of water.
Procedure— [NOTE—For each test,employ a clean,unused,250-mLglass jar.]Transfer a quantity of finely powdered Tablets,equivalent to 20mg of simethicone,to a clean,unused,cylindrical 250-mLglass jar,fitted with a 50-mm cap,containing 100mLof Foaming solutionthat has been warmed to 37.Proceed as directed for Procedurein the test for Defoaming activityunder Simethicone,beginning with “Cap the jar.”The defoaming activity time does not exceed 45seconds.
Assay— Weigh and finely powder not less than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 50mg of simethicone,to a round,narrow-mouth,screw-capped,120-mLbottle,and proceed as directed in the Assayunder Simethicone,beginning with “add 25.0mLof toluene,”except that for Tablets labeled as gelatin-coated,shake for 30minutes,instead of 5minutes.Calculate the quantity,in mg,of [-(CH3)2SiO-]nin the portion of Tablets taken by the formula:
25C(AU/AS),
in which Cis the concentration,in mg per mL,of USP Polydimethylsiloxane RSin the Standard solution,and AUand ASare the absorbances of the solution from the Tablets and the Standard solution,respectively.
Auxiliary Information— Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 1770
Pharmacopeial Forum:Volume No.30(4)Page 1295
Phone Number:1-301-816-8251
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