New Monograph on Near Infrared Spectroscopy in the USP

GMP News No. 225

GMP-News
24 August 2002
 

New Monograph on Near Infrared Spectroscopy in the USP

 
A new Monograph on near infrared spectroscopy has now been incorporated into the "Second Supplement to USP 25 and to NF 20", which came into force on 1 August 2003. You can find this Monograph titled NEAR-INFRARED SPECTROPHOTOMETRY in the General Chapters in section <1119>.

A Monograph on NIR was included into the European Pharmacopoeia already some years ago (Ph.Eur. 2.2.40 NIR absorption spectroscopy). After long discussions about the first draft for a US NIR Monograph, the final version has now been adopted. It is a pity that the Monograph is not a harmonised standard. However, the NIR Monograph has been incorporated into the general part of the USP (numbers greater than <1,000>), which is meant for broad information.

This new USP Monograph is very detailed and contains among others data on instrument specifications that are recommended or on instrument qualification (i.e. Instrument Operational Qualification and Performance Verification). Furthermore, you will find information on suitable NIST - calibration standards for checking the correct wave length.

If you are interested in compliance topics for pharmaceutical QC labs, we recommend you

Author:
Dr Günter Brendelberger
CONCEPT HEIDELBERG
  

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