Benzoic acid, 3,4,5-trihydroxy-, propyl ester;
Propyl gallate [121-79-9]
BRIEFING
Propyl Gallate. This proposal is based on the version of the monograph official as of May 1, 2020. On the basis of comments and data received, it is proposed to make the following revisions:
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In Identification B, replace the Spectroscopic Identification Tests based on ultraviolet-visible spectroscopy with a Chromatographic Identity test based on the retention time agreement of the main peak from the Standard solution and Sample solution, as obtained in the Assay.
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In the Assay, replace the procedure based on ultraviolet-visible spectroscopy with a HPLC procedure performed with the Agilent Zorbax Eclipse XDB-C18 brand of column with L1 packing.
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Add a test for Related Substances based on the HPLC procedure in the Assay. The typical retention times for gallic acid, methyl gallate, ethyl gallate, and propyl gallate are about 2.1, 5.8, 10.2, and 15.8 min, respectively.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
(SE: G. Holloway)
Case ID—SUB-513