New JP Ultraviolet-Visible and Infrared Reference Spectra Published
Recommendation

Thursday, 3 September 2026 9 .00 - 17.00 h
Establishment, Use and Maintenance of Analytical Reference Substances
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
01.07.2026Several FDA Warning Letters and Untitled Letters on Asbestos Testing of Talc in OTC Drug Products
24.06.2026Analytical Quality Group Developments January through April 2026
17.06.2026BioPhorum Publishes a Roadmap for QC Sample Test Execution
03.06.2026EMA Provides an Outlook on the Product-Specific Bioequivalence Guidelines Expected in 2026
03.06.2026FDA Warning Letter: Missing Method Validation - From a QC Topic to a Market-Access Problem
28.05.2026WHO Working Document on Bioequivalence open for Public Consultation


