Dipivefrin Hydrochloride Ophthalmic Solution
» Dipivefrin Hydrochloride Ophthalmic Solution is a sterile, aqueous solution of Dipivefrin Hydrochloride. It contains not less than 90.0 percent and not more than 115.0 percent of the labeled amount of C19H29NO5·HCl. It contains a suitable antimicrobial agent and may contain stabilizers, suitable buffers, and chelating agents.
Packaging and storage— Preserve in tight, light-resistant containers.
USP Reference standards 11
USP Dipivefrin Hydrochloride RS Click to View Structure
Identification— It meets the requirements for Identification test B under Dipivefrin Hydrochloride.
Sterility tests 71: meets the requirements.
pH 791: between 2.5 and 3.5.
Assay—
Mobile phase and Chromatographic system—Prepare as directed in the Assay under Dipivefrin Hydrochloride.
Standard preparation— Dissolve a suitable quantity of USP Dipivefrin Hydrochloride RS, accurately weighed, in 0.0015 N hydrochloric acid to obtain a solution having a known concentration of about 1 mg per mL.
Assay preparation— Transfer an accurately measured volume of Ophthalmic Solution, equivalent to about 25 mg of dipivefrin hydrochloride, to a 25-mL volumetric flask, dilute with 0.0015 N hydrochloric acid to volume, if necessary, and mix.
Procedure— Proceed as directed in the Assay under Dipivefrin Hydrochloride. Calculate the quantity, in mg, of C19H29NO5·HCl in each mL of the Ophthalmic Solution taken by the formula:
(25C / V)(rU / rS)
in which C is the concentration, in mg per mL, of USP Dipivefrin Hydrochloride RS in the Standard preparation; V is the volume, in mL, of Ophthalmic Solution taken; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Feiwen Mao, M.S.
Senior Scientific Liaison
1-301-816-8320
(SM32010) Monographs - Small Molecules 3
Reference Standards RS Technical Services
1-301-816-8129
rstech@usp.org
71 Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison
1-301-816-8339
(GCM2010) General Chapters - Microbiology
USP35–NF30 Page 2937
Pharmacopeial Forum: Volume No. 26(6) Page 1541