14/15 June 2021
GMP News No. 225
24 August 2002
New Monograph on NearInfrared Spectroscopy in the USP
A Monograph on NIR was included into the European Pharmacopoeia alreadysome years ago (Ph.Eur. 2.2.40 NIR absorption spectroscopy). After longdiscussions about the first draft for a US NIR Monograph, the finalversion has now been adopted. It is a pity that the Monograph is not aharmonised standard. However, the NIR Monograph has been incorporated intothe general part of the USP (numbers greater than <1,000>), which ismeant for broad information.
This new USP Monograph is very detailed and contains among others dataon instrument specifications that are recommended or on instrumentqualification (i.e. Instrument Operational Qualification andPerformance Verification). Furthermore, you will find information onsuitable NIST - calibration standards for checking the correct wavelength.