Dipivefrin Hydrochloride Ophthalmic Solution
»Dipivefrin Hydrochloride Ophthalmic Solution is a sterile,aqueous solution of Dipivefrin Hydrochloride.It contains not less than 90.0percent and not more than 115.0percent 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.
Identification— It meets the requirements for Identificationtest Bunder Dipivefrin Hydrochloride.
Sterility Tests á71ñ: meets the requirements.
pHá791ñ: between 2.5and 3.5.
Assay—
Mobile phase and Chromatographic system—Prepare as directed in the Assayunder Dipivefrin Hydrochloride.
Standard preparation— Dissolve a suitable quantity of USP Dipivefrin Hydrochloride RS,accurately weighed,in 0.0015Nhydrochloric acid to obtain a solution having a known concentration of about 1mg per mL.
Assay preparation— Transfer an accurately measured volume of Ophthalmic Solution,equivalent to about 25mg of dipivefrin hydrochloride,to a 25-mLvolumetric flask,dilute with 0.0015Nhydrochloric acid to volume,if necessary,and mix.
Procedure— Proceed as directed in the Assayunder Dipivefrin Hydrochloride.Calculate the quantity,in mg,of C19H29NO5·HCl in each mLof the Ophthalmic Solution taken by the formula:
(25C/V)(rU/rS),
in which Cis the concentration,in mg per mL,of USP Dipivefrin Hydrochloride RSin the Standard preparation;Vis the volume,in mL,of Ophthalmic Solution taken;and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(PA6)Pharmaceutical Analysis 6
USP28–NF23Page 673
Pharmacopeial Forum:Volume No.26(6)Page 1541
Phone Number:1-301-816-8389
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