BRIEFING
Cyclophosphamide Capsules. This proposal is based on the version of the monograph official as of May 1, 2023. Based on the supporting data, it is proposed to make the following changes:
-
Add Identification B by infrared 197K as an orthogonal test.
-
Add the HPLC Run time to the Dissolution test for clarity.
-
In the test for Organic Impurities, add a table and Note in the System suitability section to the present relative retention times as an aid in peak assignment, and revise the table in the Acceptance criteria section to list only the limits for the specified degradation products, any unspecified degradation product, and total degradation products.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
(SM3: L. Lasker)
Correspondence Number—C298395