Doxylamine Succinate Oral Solution
» Doxylamine Succinate Oral Solution contains not less than 92.0 percent and not more than 108.0 percent 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 50 mg of doxylamine succinate, and proceed as directed under IdentificationOrganic Nitrogenous Bases 181, 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 501, determining the absorbance at the wavelength of maximum absorbance at about 262 nm. Calculate the quantity, in mg, of doxylamine succinate (C17H22N2O·C4H6O4) in each mL of the Oral Solution taken by the formula:
(0.05C / V)(AU / AS)in which C is the concentration, in µg per mL, of USP Doxylamine Succinate RS in the Standard Preparation; and V is the volume, in mL, of Oral Solution taken.
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USP32NF27 Page 2216Pharmacopeial Forum: Volume No. 28(2) Page 292