BRIEFING
Hydroxyethyl Cellulose. This proposal is based on the version of the monograph official as of June 1, 2023. The European Pharmacopeia is the coordinating pharmacopeia for the international harmonization of the compendial standards for the Hydroxyethyl Cellulose monograph, as part of the process of international harmonization of monographs and general analytical methods of the European, Indian, Japanese, and United States pharmacopeias. The following monograph, which is the OFFICIAL INQUIRY STAGE 2, Revision 1 document, is based on the comments from the PDG Pharmacopoeias. Changes from the current existing NF monograph in the Assay section include the following:
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Remove details of vial and heater block dimensions so that any suitable apparatus can be used.
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Change the amount of hydroiodic acid from “1.0 mL” to “2.0 mL”.
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Change the requirement for the difference of the total mass before and after heating from “10 mg” to “26 mg”.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
(EXC: J. Liu)
Correspondence Number—C339397