1-Octadecanol;
Octadecan-1-ol [112-92-5]
BRIEFING
Stearyl Alcohol. This proposal is based on the version of the monograph official as of December 1, 2023. On the basis of comments and data received, it is proposed to make the following changes:
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Remove the note included in the Assay to guarantee its adaptability to all sources of stearyl alcohol manufacturers.
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Because the System suitability solution for both Organic Impurities, Procedure 1 and Organic Impurities, Procedure 2 exclusively utilizes 1-pentadecanol, revise the label for 1-pentadecanol in Table 3 and Table 4 to reflect its role as the internal standard for the Assay. Additionally, in order to maintain consistency and enhance clarity, the categories within the Acceptance criteria for Organic Impurities, Procedure 2 have been updated.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
(CE: S. Saladi)
Correspondence Number—C295136