Doxylamine Succinate Syrup
(Current title—not to change until June 1,2005)
Monograph title change—to become official June 1,2005
See Doxylamine Succinate Oral Solution
»Doxylamine Succinate Syrup contains not less than 92.0percent and not more than 108.0percent of the labeled amount of C17H22N2O·C4H6O4.
Packaging and storage— Preserve in tight,light-resistant containers.
Identification— Use a volume of Syrup equivalent to about 50mg of doxylamine succinate,and proceed as directed under Identification—Organic Nitrogenous Bases á181ñ,beginning with “Transfer the liquid to a separator.”The Syrup meets the requirements of the test.
Assay— Proceed with Syrup as directed under Salts of Organic Nitrogenous Bases á501ñ,determining the absorbance at the wavelength of maximum absorbance at about 262nm.Calculate the quantity,in mg,of C17H22N2O·C4H6O4in each mLof the Syrup taken by the formula:
(0.05C/V)(AU/AS),
in which Cis the concentration,in µg per mL,of USP Doxylamine Succinate RSin the Standard Preparation;and Vis the volume,in mL,of Syrup taken.
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 702
Pharmacopeial Forum:Volume No.28(2)Page 292
Phone Number:1-301-816-8379
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