BRIEFING
Chlorophyllin Copper Complex Sodium. This proposal is based on the version of the monograph official as of June 1, 2023. It is proposed to revise the monograph with the following changes:
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For Identification A, replace the "Ultraviolet-Visible Spectroscopy 〈857〉 (in the visible region)" with "Spectroscopic Identification Tests 〈197〉" for clarity.
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In the test for Content of Total Copper:
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Revise the preparation procedures of Standard stock solution 1, Standard stock solution 2, Standard solutions, and Sample solution to give users flexibility.
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List the preparation of the Sample stock solution separately from the Sample solution with the target concentration for improved clarity.
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In the Analysis section, update the calculation formula to the current format.
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In the test for Content of Sodium:
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List the nonionic wetting agent solution as Solution A with the concentration expressed in mg/mL for clarity.
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Revise the preparation procedure of the Standard stock solution, Sample solution, and Blank to improve the flexibility.
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Add the section Instrumental conditions for clarity.
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In the Analysis section:
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Add Blank to the list of Samples.
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Update the calculation formula to the current format.
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In the Limit of Ionic Copper test:
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Include Standard stock solution 1, Standard stock solution 2, and Instrumental conditions in reference to the test for Content of Total Copper.
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In the Analysis section, update the calculation formula to the current format.
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Delete the reference to Microbial Enumeration Tests 〈61〉, as no related acceptance criteria in this general chapter is applicable to the article.
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Delete the Test for Fluorescence, as the red optical filter specified in the test is not available on the market anymore.
Stakeholders are encouraged to submit supporting information to further modernize the monograph.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
(SM3: J. Li)
Case ID- SUB-2064