Posting Date: 30-Apr-2021; updated 09–Aug–2021*
Expert Committee: Excipients Test Methods
Input Deadline: 30-May-2021
Proposed New Title: <1901> Theory and Practice of Asbestos Detection in Pharmaceutical Talc
Suggested audience: pharmaceutical industry and excipient manufacturers, users and distributors, academia, QA/QC specialists, formulators, regulatory affairs, and governmental agencies.
Estimated proposal PF: Pharmacopeial Forum 48(1) [Jan.–Feb. 2022]
Background and objective: To complement the proposal of a new General Chapter <901> Detection of Asbestos in Pharmaceutical Talc, which focuses only on the testing procedures, this general chapter will provide the background information and recommended practice of the methodologies described in General Chapter <901>, including X-Ray Diffraction (XRD) and Polarized Light Microscopy (PLM), etc.
Description of scope and application: As part of the USP Talc monograph Phase 1 revision (refer to Stimuli article Modernization of Asbestos Testing in USP Talc—Part 2, found in PF 46(5)), the new informational General Chapter <1901> will provide background information, principles and recommendations for performing proper analysis of XRD and PLM, in addition to the testing procedures described in General Chapter <901>. Electron microscopy tests including transmission electron microscopy (TEM) and scanning electron microscopy (SEM) will be investigated as part of the Phase 2 revision, and these methodologies will be included in this informational chapter at a future time.
Preliminary outline: The following represents the sections for the proposed General Chapter:
- INTRODUCTION
- X-RAY DIFFRACTION (XRD) – background, principles and practices for powdered samples.
- POLARIZED LIGHT MICROSCOPY (PLM) – background, principles and practice.
Anticipated implementation timing: To be determined based on stakeholder feedback.
Additional Information: USP published a Stimuli article in PF 46(5). A proposed new General Chapter <901> Detection of Asbestos in Pharmaceutical Talc will be published in the same PF because <901> will cross-refence this informational chapter for additional information related to the principles and recommended practice of the methodologies. Additionally, the USP Talc monograph revision proposal will be published in the same PF because the Test for Asbestos in the USP Talc monograph will cross-reference the new chapter <901>.
A separate prospectus regarding the new general chapter <901> Detection of Asbestos in Pharmaceutical Talc can be found here.
Furthermore, USP is planning to hold an open forum to further engage stakeholders and solicit their feedback after the proposals of the new general chapters and the revision proposal of the Talc monograph are published in PF.
Contact: Tong (Jenny) Liu, Ph.D., Principal Scientist, at (240)221-2072, jyl@usp.org
CN-21-054-01
* This Notice was updated on August 9, 2021 to update the PF in which the proposal is expected to appear.