Packaging and storage— Preserve in tight, light-resistant containers.

USP Reference standards 11— USP Doxylamine Succinate RS.

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.

Residual solvents 467: meets the requirements.

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: 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.

Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids

USP29–NF24 Page 768

Phone Number : 1-301-816-8143