Oxymetazoline Hydrochloride Ophthalmic Solution
» Oxymetazoline Hydrochloride Ophthalmic Solution is a sterile, buffered 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. It contains a suitable preservative.
Packaging and storage— Preserve in tight containers.
Identification— A volume of Ophthalmic Solution, equivalent to about 2.5 mg of oxymetazoline hydrochloride, responds to the Identification test under Oxymetazoline Hydrochloride Nasal Solution.
Sterility 71: meets the requirements.
pH 791: between 5.8 and 6.8.
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 Ophthalmic Solution.
Assay preparation— Use Ophthalmic 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 Ophthalmic 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.
Scientist
1-301-816-8320		 (MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339		 (MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 3175
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.