Benzoic acid, 3-amino-4-propoxy-, 2-(diethylamino)ethyl ester, monohydrochloride;
2-(Diethylamino)ethyl 3-amino-4-propoxybenzoate monohydrochloride [5875-06-9]
BRIEFING
Proparacaine Hydrochloride. This proposal is based on the version of the monograph official as of May 1, 2021. It is proposed to revise the monograph with the following changes:
-
Add the Unique Ingredient Identifier (UNII) Code for Proparacaine Hydrochloride to the Chemical Information section.
-
Replace the use of Identification–Organic Nitrogenous Bases 〈181〉 in Identification A with infrared spectroscopy.
-
Replace the use of ultraviolet absorption in Identification B with the chromatographic retention time agreement using the proposed Assay.
-
Replace the titration-based Assay with a liquid chromatographic procedure which was validated using the XBridge BEH Shield RP18 brand of column with L1 packing. The typical retention time for proparacaine is about 22 min.
-
Revise the Acceptance criteria in the Assay from 97.0%–103.0% to 98.0%–102.0%, which is typical for a liquid chromatographic procedure. The Definition is revised accordingly.
-
Replace the TLC-based test for Ordinary Impurities with the test for Organic Impurities using liquid chromatography. The liquid chromatographic procedure was validated using the XBridge BEH Shield RP18 brand of column with L1 packing. The typical retention time for proparacaine is about 22 min.
-
Remove the nonspecific test for Melting Range or Temperature, as the monograph proposal contains sufficient tests to ensure the quality of the drug substance.
-
Add Bacterial Endotoxins Test to meet the requirements in relevant sterile dosage forms.
-
Update the Packaging and Storage section to add storage conditions.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
(SM5: V. Durga Prasad)
Case ID—SUB-2252