Benzeneethanamine, N,α-dimethyl-, hydrochloride, (S)-;
(+)-(S)-N,α-Dimethylphenethylamine hydrochloride [51-57-0]
BRIEFING
Methamphetamine Hydrochloride. This proposal is based on the version of the monograph official as of May 1, 2020. It is proposed to revise the monograph with the following changes:
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The Acceptance criteria in the Definition and Assay are revised from 98.5%–100.5% to 98.0%–102.0% to be consistent with drug substance monographs.
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Revise Identification A to allow the flexibility of using either 197A or 197K.
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Add Identification B with the chromatographic retention time agreement from the Assay.
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Rename Identification B to Identification C.
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In the Assay:
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Rename "diluted glacial acetic acid (7 in 50)" in the Mobile phase as Solution A.
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In the Chromatographic system section, add the particle size of the analytical Column and a Run time for clarity.
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In the System suitability section, tighten the %RSD from NMT 2.0% to NMT 0.73% to be consistent with the expectations for modern chromatographic systems, based on the supporting data and delete the Column efficiency requirement.
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Organic Impurities test is not included in this revision. Stakeholders are encouraged to submit their FDA-approved specifications for the Expert Committee's consideration.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
(SM2: M. Fadadu)
Case ID—SUB-1288