5H-Dibenzo[a,d]cycloheptene-5-propanamine, N-methyl-, hydrochloride;
N-Methyl-5H-dibenzo[a,d]cycloheptene-5-propylamine hydrochloride [1225-55-4]
BRIEFING
Protriptyline Hydrochloride. This proposal is based on the version of the monograph official as of May 1, 2022. On the basis of comments received, it is proposed to revise Identification C to update the reference to tests A and B in Identification Tests—General 〈191〉, Chemical Identification Tests, Chloride. Tests A and B no longer exist separately in 〈191〉, as these were merged in a recent update to the chapter. The following changes to the monograph are also proposed:
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Revise Identification A to allow the flexibility of using either 197K or 197M.
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Update the reference in Identification D to Spectroscopic Identification Tests 〈197〉, X-Ray Powder Diffraction, 197XR, since it is a part of spectroscopic identification tests.
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Add the calculation in the Analysis of the Assay.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
The comment period for this revision ends on September 30, 2024. In the absence of any significant adverse comment, it is proposed to implement this revision via an Interim Revision Announcement with an official date of January 1, 2025.
(SM4: D. Singh)
Correspondence Number—C328885