Posting Date: 26–Mar–2021
Input Deadline: 25–Apr–2021
Expert Committee: General Chapters–Dosage Forms
Suggested audience: Suppliers and manufactures of drug substance, biologics, drug products, excipients, parenteral products, medical devices, regulatory agencies, and QA/QC specialists.
Estimated proposal PF: Pharmacopeial Forum 47(6) [Nov.- Dec. 2021]
Background and objective: USP intends to develop a new informational chapter that contains recommendations for the selection, characterization, integrity evaluation, use and qualification of filters and membranes used in procedures such as, but not limited to, dissolution, chromatography, general sample preparation procedures, and in-vitro release testing.
Preliminary outline: The following represents the sections for the proposed General Chapter.
- Pore size and pore morphology
- Types of membranes and their characteristics
- Leachables and Extractables
- Analyte Binding
- Integrity evaluation
- Uses and Applications
Anticipated activities: USP is requesting early input from stakeholders on this proposal of a new chapter General Chapter <1002> Filters and Membranes which is planned to be published for comments in the Pharmacopeial Forum.
Contact: Margareth R. C. Marques (email@example.com)