The majority of active pharmaceutical ingredients exhibit two or more crystalline forms, which - showing significant variation in properties such as solubility, dissolution rate and stability – directly impact drug product quality and performance. Form selection and control is therefore highly important through all stages of drug development and manufacturing.
The minispec Form Check approaches the quantification of solid forms from a completely different angle than other techniques (e.g. PXRD, Raman, IR), using longitudinal (T1) NMR relaxation to distinguish phases and taking advantage of the inherently linear relationship between sample mass and signal intensity of nuclear magnetic resonance. This notably allows quantification of low levels of amorphous content with the same certainty as crystalline forms, where other methods (like XRD or thermal analysis) are challenged with significant quantitation errors.
The new minispec Form Check 2.0 combines the reliable minispec mq20 benchtop spectrometer with the well-established IconNMR interface for simple experiment submission, and Mestre’s Mnova software for automatic data analysis.
Karl Ratzsch will start with the introduction of the new minispec FormCheck 2.0, a solution for polymorph and amorphous form quantification using benchtop TD-NMR.
Luca Venturi will then discuss how the relaxation parameters of a given pair of solid forms influences the accuracy of the Form Check experiment, using a combination of experimental and in-silico data to give the user a thorough understanding of the range of applicability of this method.
The webinar is aimed at those working in the pharmaceutical industry, especially in drug development and production of pharmaceuticals: laboratory managers, heads of R&D, analytical development, quality control and manufacturing.
The webinar is also of interest to academics collaborating with pharmaceutical industry and to other industries who face challenges in formulating solid mixtures.
Karl Ratzsch, PhD
Scientist, Bruker Biospin GmbH, Germany
Luca Venturi, PhD
NMR Specialist, Chiesi Farmaceutici SPA, Italy
Dr. Matteo Pennestri
Product Manager, Pharmaceutical Business Unit, Bruker