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Simethicone Emulsion
Simethicone Emulsion

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» Simethicone Emulsion is a water-dispersible form of Simethicone composed of Simethicone, suitable emulsifiers, preservatives, andwater. It may contain suitable viscosity-increasing agents. It contains an amount of polydimethylsiloxane ([–(CH3)2SiO–] ) that is not less than 85.0 percent and not more than 110.0 percent of thelabeled amount of simethicone.
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Packaging and storage— Preserve in tight containers. USP Reference standards 11 — USP Polydimethylsiloxane RS. Identification— The IR absorption spectrum, determinedin a 0.5-mm cell, of the solution of Emulsion prepared as directed in the Assay, exhibits maxima only at the same wavelengths as that of a similar preparation of USP Polydimethylsiloxane RS. Ifnecessary, the dilute hydrochloric acid may be omitted to improve separation. [NOTE—Prepare a procedural blank by similarly treating 25.0 mL of toluene, and use this blank to set the instrument.] Microbiallimits 61 — Its total aerobic microbial count does not exceed 100 cfu per g.

Heavy metals— Using Simethicone Emulsion instead of Simethicone, proceed as directed for Heavy metals under Simethicone.The limit is 5 µg per g. Defoaming activity— Foaming solution— Dissolve 1 g of octoxynol 9 in 100 mL of water. Test preparation— Transfer an accurately weighed quantity of Emulsion, equivalent to 300mg of simethicone, to a 60-mL bottle, dilute with water to 30 g, cap the bottle, and shake vigorously. Procedure— Proceed as directed for Procedure in the test for Defoaming activity underSimethicone. The defoaming activity time does not exceed 15 seconds. Assay— Transfer an accurately weighed quantity of Emulsion, equivalent to about 50 mg of simethicone, to a round, narrow-mouth, screw-capped,120-mL bottle, add 25.0 mL of toluene, and swirl to disperse. Proceed as directed in the Assay under Simethicone, beginning with “Add 50 mL of dilute hydrochloric acid.” Calculate the quantity, in...