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Scope Develop protocols to understand the thermal stability of individual polymorphs Provide mechanistic understanding on desolvation/ dehydration structural arrangement or cooperative mechanism of individual polymorphs In Situ Variable Temperature- FTIR ATR Measurements Chennuru R, Muthudoss P, Voguri RS, Ramakrishnan S, Vishweshwar P, Babu RR, Mahapatra S. Iso-structurality induced solid phase transformations: a case study with

1. Chemical Structure (See Left), SCXRD, XRD, pKa Rule indicated that the Febuxostat and Telmisartan can form a Salt (No Salts reported for both forms even with highly acidic/basic salt formers) 2. Orthogonal Investigation Carried Out FTIR: Presence of Carbonyl Group (Except Shift) and Absence of “M” Shaped Canine Teeth Carboxylate Peak between 1650 cm-1

Solid State techniques were applied to investigate API raw material attributes and their impact on the final dosage formulations between two API vendors. XRD, DSC, TGA No polymorphic changes but crystal morphological variations could be observed between APIs SEM Sun API is morphologically uniform, however, Symed API has particles of different shapes and sizes Raman

Problem Statement Micronized API demonstrated slower dissolution than the Unmicronized API No changes in polymorphism or particle size is envisaged Business Need To study the effect of agglomeration on micronized model active pharmaceutical ingredient (API) and to unravel the influence of API agglomerate strength on dissolution and permeation Comparison of Intrinsic Dissolution from Solution vs.

Business Need Topologically directed confocal Raman imaging (TD-CRI) can be successfully employed to reverse engineer RLD on following API/excipient particle size API/excipient polymorphism Compositional distribution of API and/or excipients Approach CRI is time-consuming and laborious procedure Statistical methods to aid in obtaining sample representativeness and sample randomization is employed using Non-parametric population analysis Bootstrapping d-statistics

NIR Based Sample Prescreening NIR-PCA Based Trend Analysis (If no trend derivable based on repeatability or reproducibility, Sample Lot is Homogeneous) Sampling Strategy: Based on NIR-PCA If homogeneous: 1 batch, 1 reproducible, 5 repeatable and 100 particles (1x1x5x100=~500 particles) would be sufficient If heterogeneous: 3 batch, 3 reproducible, 5 repeatable and 100 particles (3x3x5x100=~4500 particles)