Doxylamine Succinate Oral Solution
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
>> 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 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.
