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.
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.
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.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Feiwen Mao, M.S.
(MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 3175
Pharmacopeial Forum: Volume No. 33(5) Page 932
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.