Revision of USP Chapter on IR Spectroscopy

Recommendation

1/2 July 2025
Berlin, Germany

Dissolution Testing
Development / Quality Control and in vivo Relevance

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.