Quantification of a trace amount of polymorphic impurities is critical especially in the quality control of Active Pharmaceutical Ingredients (APIs). Conventional quantitative analysis by X-ray diffraction (XRD) requires calibration curve preparation, reference intensity ratio (RIR) or crystal structure (Crystallographic Information File, CIF). However, the materials of APIs are often missing from the database. Therefore, their quantification is not straightforward. Rigaku have developed a novel quantitative analysis method called “Direct Derivation (DD)” that requires only XRD data and chemical formula. Here, quantitative analysis of trace amounts of the hydrate phase of API is performed using the DD method and the limit of quantification (LOQ) is calculated.
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
Compact X-ray diffractometer for quality control of materials that is easy to use and is ideal for routine work
Windows®-based software suite for Rigaku's X-ray diffractometers
Laboratory micro-spot XRD residual stress analysis with both iso- and side-inclination methods