Thioctic acid;
1,2-Dithiolane-3-pentanoic acid;
1,2-Dithiolane-3-valeric acid [1077-28-7]
BRIEFING
Alpha Lipoic Acid. This proposal is based on the version of the monograph official as of May 1, 2020. On the basis of comments received, it is being proposed to make the following changes:
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Revise the preparation instructions for the Standard solution and Sample solution in the Assay to address a potential solubility issue. It is being proposed to dissolve initially in methanol, NMT 5% of the total solution volume, followed by dilution with Mobile phase to final volume.
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Delete the Column efficiency requirement from System suitability for the HPLC procedure in the Assay. The remaining requirements are sufficient to establish system suitability.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
(NBDS: N. Batchu)
Case ID—SUB-2998