Polymorphism: Quality rationalization, mitigation and authentication strategies with respect to regulatory compliances in pharmaceutical industry

Phase purity of active pharmaceutical ingredients (API) affects a range of physical, chemical and biological properties such as dissolution rate, stability and bioavailability. The pharmaceutical industry has frequently recourse the milling, shifting and drying which causes the impacts on phase of products. The different phases of products known as polymorphism and has become the challenge in pharmaceutical industry, in order to meet the specific polymorph of an individual product with respect to its quality specification. Pharmaceutical solids often exhibit polymorphism, which leads to different physiological properties; therefore, the understanding of manufacturing and control of polymorphic forms are essential aspects for product development and regulatory compliances in the pharmaceutical industry. X-ray powder diffraction (XRPD) is generally used for the characterization of polymorphism. XRPD method provides an advantage over other means of analysis in that it is usually non-destructive nature. XRPD investigations can also be carried out under in situ conditions and specimens exposed to non-ambient conditions such as low or high temperature and humidity.