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.
USP Reference standards 11
USP Doxylamine Succinate RS Click to View Structure
Identification— Use a volume of Oral Solution equivalent to about 50 mg of doxylamine succinate, and proceed as directed under Identification—Organic 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.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Domenick Vicchio, Ph.D.
Senior Scientific Liaison
(SM42010) Monographs - Small Molecules 4
Reference Standards RS Technical Services
USP35–NF30 Page 2990
Pharmacopeial Forum: Volume No. 28(2) Page 292