New JP Ultraviolet-Visible and Infrared Reference Spectra Published
Recommendation
Monday, 29 September 2025 14.00 - 17.00 h
Register now for ECA's GMP Newsletter
In March 2023, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has published the "JP Drafts (March 2023) No.2". In this context, five new Ultraviolet-visible and Infrared reference spectra were published.
The following spectra were made available as PDF files:
- Aripiprazole
- Febuxostat
- Lornoxicam
- Oxaliplatin
- Tolvaptan
New monographs of these and for a few other APIs and tablets have also been published.
The comment period runs from 01 March to 31 May 2023. To submit remarks, a form for comments has to be downloaded and sent by e-mail to the authority after it has been filled in.
Related GMP News
15.09.2025USP-NF Stimuli Article on Apex Vessels used in Dissolution Testing: Corrected Version Published
27.08.2025FDA Warning Letter: Missing Identity Tests, Unverified CoAs, and Inadequate DEG/EG Controls
20.08.2025USP Responds to Comments on Chapter <202> HPTLC Identification of Fixed Oils
13.08.2025USP publishes Comments rereived on Chapter <317>
13.08.2025FDA Issues Warning Letter to Contract Testing Laboratory for Inadequate OOS Investigations
06.08.2025EMA publishes Overview of Comments received on ICH M13B Guideline on Bioequivalence