ABSTRACT

Evaluation of polymorphic forms of sample specimens has secured an inevitable importance across the pharmaceutical industry as it is scientifically proven that, the alteration of small change in polymorphic form of drug substance and/or drug product may end up with significant changes in physico-chemical properties of solids. The aforesaid polymorphic evaluation can be achieved by powder XRD technique which is primary analytical tool globally used by crystallographers for the determination of polymorphic forms. However sample preparation is key attribute while using powder XRD tool for said evaluation. The illegitimate sample preparation may lead to ambiguous data and falsification of conclusion. As sample specimens meant for polymorphic assessment may have different physical nature, a practical and enriched skill-set is required to reach to the desired goal. In this paper, we focused on various sample types, their physical nature, polymorphic targets and road map for sample preparations. Also we covered expectations of regulatory agencies from pharmaceutical industries as far polymorphic data is concerned. Keywords: Powder XRD, Regulatory agency, Ointments, DPIs, Suspensions
Publication date: 01/10/2021

https://ijbpas.com/pdf/2021/October/MS_IJBPAS_2021_OCT_SPCL_1043.pdf

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https://doi.org/10.31032/IJBPAS/2021/10.10.1043