Setting meaningful and realistic specifications for pharmaceutical product Critical Material Attributes (CMAs) is an important in ensuring a product meets its target performance profile. Within this, the polymorphism and crystallinity of the Active Pharmaceutical Ingredients (APIs) and excipients present within a product formulation are crucial. Presence of an undesired polymorph could lead to a reduction in therapeutic benefit, due to changes in API solubility, and may even cause an adverse effect to the patient. Polymorph selection, and conformation of polymorphic stability over time, is therefore vital. This becomes even more important when an amorphous for of the API is selected to improve solubility, as unexpected crystallization of an insoluble form can be fatal.

This webinar series will consider the guidance available regarding polymorph and crystallinity analysis for pharmaceutical products and how appropriate methods can be developed using the technique of X-Ray Powder Diffraction (XRPD).

In this first presentation we will discuss why a polymorph specification may be required. We’ll review the guidance provided in ICH Q6A, which recommends that formulation developers consider how product bioavailability, uniformity, stability and processability may be impacted by structural changes. We will then consider how XRPD can aid formulation developers in material selection and in understanding the impact of formulation processing operations on product performance.


June 09 2020 - June 09 2020
10:30 - 11:30
(GMT+05:30) India
Event type:
Webinar - Live


What you would learn
- Understand why polymorphism is important for pharmaceutical products
- Gain a better understanding of the regulatory guidance relating to XRPD
- Understand how XRPD can be applied within pharmaceutical development


Dr Natalia Dadivanyan, XRD Application Specialist, Malvern Panalytical's Supply Center in the Netherlands
Dr Natalia studied chemistry at Moscow State University (Russia). After completing her master thesis on synthesis and characterization of polymer liquid crystalline films Natalia moved to University of Freiburg (Germany) to obtain her PhD degree working on liquid crystalline elastomers. This was followed by a post-doc position at the Eindhoven University of Technology (The Netherlands), where Natalia focused on organic semi-conductors. In 2012 Natalia joined Malvern Panalytical as an Application Specialist XRD, in Almelo (The Netherlands).

Dr Mangesh Mahajan, XRD Application Specialist at Malvern Panalytical
Dr Mahajan has a Ph.D. and postdoctoral experience in material science from National Chemical Laboratory, Pune, India. For more than 12 years, Dr Mahajan has used multiple characterization techniques for various materials. In 2016, he joined Malvern Panalytical as an application specialist for X-ray diffraction. In his line of work, he has been instrumental in supporting various customers in pharmaceuticals, cements, mining and metal industries, universities, national institutions and more. This spans from advising on applications, experimental set up, samples analysis, proof of concept through to helping clients optimise the use of their XRD instrumentation.

Dr Sandeep Nagar, XRD Application Specialist at Malvern Panalytical
Dr Nagar has 16 years of R and D experience. He completed his PhD in Materials Science from KTH Sweden in 2012. He thereafter taught at various Indian universities as an Assistant Professor for 6 years. In 2018, he joined Malvern Panalytical as an application specialist for X-ray diffraction. In his work, he has provided application and technical support to customers from various industries including academic research, to mining, steel, cement, pharmaceuticals and more. His area of specialty is in mineralogical and structural research using X-ray diffraction.

Amol Pandit, Manager for Pharmaceutical Solutions involving X-ray diffraction at Malvern Panalytical

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