Development and validation of analytical methodology for near-infrared conformance testing of pharmaceutical intermediates

Journal of Pharmaceutical and Biomedical Analysis
R A ForbesD R Smith

Abstract

An approach was developed to create and validate analytical methods to perform near-infrared (NIR) conformance testing on two isolated intermediates used in the manufacture of loracarbef monohydrate bulk drug substance. Method calibration sets were developed from second-derivative NIR reflectance spectra for 30 representative batches of each intermediate. In conformance testing, second-derivative NIR spectra for samples from newly manufactured batches are compared with the calibration set. If the new spectrum is not statistically different to the average of the calibration set, the sample passes the conformance test. Using authentic batch samples of typical and low-potency lots, the methods were validated for accuracy, selectivity, ruggedness and repeatability of the methods.

References

Oct 1, 1992·Journal of Pharmaceutical and Biomedical Analysis·W Plugge, C van der Vlies
Nov 1, 1993·Journal of Pharmaceutical and Biomedical Analysis·B F MacDonald, K A Prebble
Jun 1, 1993·Journal of Pharmaceutical and Biomedical Analysis·W Plugge, C Van der Vlies

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Citations

Mar 29, 2001·Journal of Pharmaceutical and Biomedical Analysis·R A ForbesD R Smith
Jan 16, 2007·Journal of Biopharmaceutical Statistics·Michiel B Nijhuis, Edwin R van den Heuvel
Dec 4, 2009·The Science of the Total Environment·Ling ZhaoHui Wang
Apr 6, 2006·Critical Reviews in Biotechnology·Matthew ScarffBrian McNeil
Jul 7, 2007·The AAPS Journal·Marian Kelley, Binodh DeSilva
Sep 28, 2010·Biomedical Chromatography : BMC·Christel GrondinEvelyne Jacqz-Aigrain
Apr 1, 2011·Pharmaceutical Methods·Muralidharan Selvadurai, Subramaniya Nainar Meyyanathan
Jun 5, 2013·Indian Journal of Hematology & Blood Transfusion : an Official Journal of Indian Society of Hematology and Blood Transfusion·Niyati Singh
Mar 21, 2018·Pharmaceutical Development and Technology·Shih-Liang HsiRaida Al-Kassas
Dec 7, 2007·Biomedical Chromatography : BMC·R EspadaJ J Torrado
May 19, 2012·Toxins·Eline P Meulenberg
Jun 20, 2013·Luminescence : the Journal of Biological and Chemical Luminescence·Ayça Karasakal, Sevgi Tatar Ulu
Dec 1, 2014·Journal of Food and Drug Analysis·Rafidah IsmailFatimah Abu Bakar
Dec 3, 2016·Analytical and Bioanalytical Chemistry·Jens ClaßenThomas Scheper
Jun 29, 1999·Analytical Chemistry·R K Gilpin, L A Pachla

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