Oxymetazoline Hydrochloride Nasal Solution
» Oxymetazoline Hydrochloride Nasal Solution is a solution of Oxymetazoline Hydrochloride in water adjusted to a suitable tonicity. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C16H24N2O·HCl.
Packaging and storage— Preserve in tight containers.
USP Reference standards 11
USP Oxymetazoline Hydrochloride RS Click to View Structure
Identification— The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
pH 791: between 4.0 and 6.5.
Assay—
Mobile phase— Prepare as directed in the Assay under Oxymetazoline Hydrochloride.
Standard preparation— Prepare a solution of USP Oxymetazoline Hydrochloride RS in Mobile phase, having a known concentration, approximately equal to the labeled concentration of the Nasal Solution.
Assay preparation— Use Nasal Solution.
Chromatographic system and Procedure—Proceed as directed in the Assay under Oxymetazoline Hydrochloride, except to calculate the quantity, in mg, of C16H24N2O·HCl in each mL of the Nasal Solution taken by the formula:
C(rU / rS)
in which the terms are as defined therein.
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Topic/Question Contact Expert Committee
Monograph Feiwen Mao, M.S.
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USP35–NF30 Page 4182
Pharmacopeial Forum: Volume No. 33(5) Page 932