Near Infra-Red spectroscopy for content uniformity of powder blends – Focus on calibration set development, orthogonality transfer and robustness testing

Author:

Casian Tibor,Iurian Sonia,Gavan Alexandru,Revnic Cornelia,Porav Sebastian,Porfire Alina,Vlase Laurian,Tomuță Ioan

Funder

Corporation for National and Community Service

Unitatea Executiva pentru Finantarea Invatamantului Superior, a Cercetarii, Dezvoltarii si Inovarii

Autoritatea Natională pentru Cercetare Stiintifică

Publisher

Elsevier BV

Subject

Analytical Chemistry

Reference46 articles.

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2. European Medicines Agency, ICH Guideline Q8 (R2) on Pharmaceutical Development, vol. 8, 2015, pp. 1–24. (doi:EMEA/CHMP/167068/2004 - ICH).

3. European Medicines Agency, Guideline on Real Time Release Testing (formerly Guideline on Parametric Release), vol. 44, 2012, pp. 1–10.

4. US FDA, Guidance for Industry Guidance for Industry PAT — A Framework for Innovative Pharmaceutical, 2004.

5. Characterization of pharmaceutically relevant materials at the solid state employing chemometrics methods;Calvo;J. Pharm. Biomed. Anal.,2018

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