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General Chapter Prospectus: New General Chapter <1003> Resuspendability- Quantitative Assessment

Type of Posting: General Chapter Prospectus
Posting Date: 27-Jan-2023
Input Deadline: 26-Feb-2023
Expert Committee: Dosage Forms Committee

Suggested audience: Manufactures of pharmaceutical drug products, regulatory agencies, and contract laboratories

Estimated proposal PF: PF 50(2) [March – April 2024] 

Background and objective: USP intends to develop a new general chapter that provides procedures for the quantitative assessment of resuspendability of any type of suspensions and powder, granules, and pellets for suspensions administered by any route of administration. The chapter will present possible quantitative techniques and/or procedures that may be used for the quantitative evidence of resuspendability. 

Anticipated activities: USP is requesting early input from stakeholders on this proposal of the new chapter General Chapter <1003> Resuspendability – Quantitative Assessment which is planned to be published for comments in Pharmacopeial Forum

Contact: Margareth R. C. Marques (