Type of Posting: Notice of Intent to Revise
Posting Date: 30-Dec-2021
Targeted Official Date: 1-Dec-2023; In Process Revision
Expert Committee: Botanical Dietary Supplements and Herbal Medicines
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Botanical Dietary Supplements and Herbal Medicines Expert Committee intends to revise the Cranberry Fruit Juice Dry Extract monograph, originally published in PF 45(6).
Comments with supporting data were received that indicate the need for changes to be made to several sections of the monograph. The Expert Committee proposes to revise the Cranberry Fruit Juice Dry Extract monograph as follows:
- Identification A. HPTLC for Articles of Botanical Origin <203>, change from L1 to L2 in the solid-phase extraction (SPE) column packing used for the preparation Sample Solution and Standard Solution C;
- Content of Total Proanthocyanidins, change in the acceptance criteria from NLT10% and NMT 24% calculated as procyanidin A2 as is, to NLT15% and NMT33% calculated as procyanidin A2 on a dried basis;
- Specific tests, Water Determination <921>, Method I, Method Ia (acceptance criteria: NMT 5%), change to Loss on Drying <731> (acceptance criteria: NMT 8%); and
- Adulterants, HPLC Profile of Phenolic Compounds, change in the acceptance criteria for the description of unknown peaks (Peaks 1-9). Editorial changes will also be made to update the monograph to the current USP style, as appropriate.
It is anticipated that the proposed revision will be published as In-Process Revision in Pharmacopeial Forum 48(3) [May–June 2022] pursuant to the Rules and Procedures of the Council of Experts. If the revisions are published as anticipated, the comment period for the revision would end on July 31, 2022.
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