Doxylamine Succinate Oral Solution
(Monograph under this new title—to become official June 1,2005)
(Current monograph title is Doxylamine Succinate Syrup)
»Doxylamine Succinate Oral Solution contains not less than 92.0percent and not more than 108.0percent of the labeled amount of doxylamine succinate (C17H22N2O·C4H6O4).
Packaging and storage— Preserve in tight,light-resistant containers.
Identification— Use a volume of Oral Solution 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 Oral Solution meets the requirements of the test.
Assay— Proceed with Oral Solution 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 doxylamine succinate (C17H22N2O·C4H6O4)in each mLof the Oral Solution 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 Oral Solution taken.
(Official June 1,2005)
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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