Skip to main content

Non-destructive measurement of pseudo-polymorph impurities in tablets

AppNote B-XRD1023: measurement of pseudo-polymorph impurities in tablets

Background

In the tableting process for pharmaceuticals, it sometimes happens that the active pharmaceutical ingredient reacts with materials used as excipients, such as sugar or starch, and dehydration reactions, polymorph transitions and other processes may occur due to the pressure during tableting. In recent years, a need has arisen to check, in the shortest possible time, whether or not the active pharmaceutical ingredient maintains its original crystal system, and whether or not there are polymorph impurities. Furthermore, this must be done in the tableting process, while maintaining the tablet form. Therefore, we used a powder X-ray diffractometer to non-destructively measure the state of tablets in their original form, and evaluate the presence of the contained active pharmaceutical ingredient and polymorph impurities. By using a transmission-type parallel beam optical system, it is possible to obtain an accurate diffraction profile which does not depend on the sample form, and acquire information not only from the outside, but also from the inside of tablets. As a result of measurement, it was found that if polymorph impurities of the active pharmaceutical ingredient are about 1%, then their presence in the tablets could be confirmed in a measurement time of less than 10 minutes.

XRD products from Rigaku

Advanced state-of-the-art high-resolution XRD system powered by Guidance expert system software

Highly versatile multipurpose X-ray diffractometer with built-in intelligent guidance

New 6th-generation general purpose benchtop XRD system for phase i.d and phase quantification

High-performance, multi-purpose XRD system for applications ranging from R&D to quality control

Laboratory micro-spot XRD residual stress analysis with both iso- and side-inclination methods

2D X-ray detector with latest semiconductor technology designed for home lab diffractometers