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Aminocaproic Acid Oral Solution

BRIEFING

 Aminocaproic Acid Oral Solution. This proposal is based on the version of the monograph official as of August 1, 2022. The following changes are proposed:

  1. Identification A is revised to provide the flexibility of using either 197A or 197K.

  2. Add a liquid chromatography procedure-based Organic Impurities test which is based on validation performed using the XSelect CSH Phenyl-Hexyl brand of column with L11 packing. The typical retention time for aminocaproic acid is about 6 min.

  3. The references to Microbial Enumeration Tests 〈61〉 and Tests for Specified Microorganisms 〈62〉 are separated to more clearly communicate the requirements associated with each of the general chapters.

 Additionally, minor editorial changes have been made to update the monograph to current USP style.

 (SM2: H. Ramanathan)

 Case ID—SUB-1051

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USP Aminocaproic Acid RS
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