Revision of USP Chapter on IR Spectroscopy
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
In the Pharmacopeial Forum No 39(2), the USP has published the draft for the revised General Chapter <854> on Mid-Infrared Spectroscopy. This draft is the second one and takes into consideration the comments sent to the USP.
Some acceptance criteria for some of the single validation parameters have been adapted in the validation of IR methods. Regarding accuracy, the recovery rate has been added to 95.0% - 105.0% for drug product assay.
Regarding precision, the relative standard deviation for repeatability is set as follows:
- Not more than 1.0% for APIs
- Not more than 2.0% for medicinal products
- Not more than 20.0% for impurities
And for intermediate precision:
- Not more than 1.0% for APIs
- Not more than 3.0% for medicinal products
- Not more than 25.0% for impurities
In addition to revised Chapter <854>, there will also be the new General USP Chapter <1854> which describes theory and practice of Mid Infrared Spectroscopy.
Both documents can be found on the Pharmacopeial Forum of the USP website.
Related GMP News
18.12.2025FDA Form 483: Excel-Based Data Falsification and Duplicate Log Books
18.12.2025Questions and Answers on System Suitability Tests (SST) - Part 1
18.12.2025PharmaLab 2025: Brief Summary of AQCG Track - Save the Date for 2026!
18.12.2025FDA Warning Letter: 1,500 OOS Results with Numerous Inadequate Investigations
17.12.2025FDA Warning Letter Criticises Handling of OOS Results at a Contract Laboratory
17.12.2025FDA Warning: No Recall Conducted Despite Confirmed Benzene Impurity