• Raman spectroscopy
• Optical emission spectroscopy
• Ultra-performance liquid chromatography
• Inductively coupled plasma mass spectrometry
• Nuclear magnetic resonance
In addition , whilst it is a routine analysis , advances have also been made in the area of stability testing . For example , this has been adjusted through the use of simulating chambers for freeze-thaw , photostability testing and chambers for all temperature zones .
Where testing helps
Advanced analytical testing can also help to alleviate the regulatory burden , providing the necessary
Table 1 – Comparison of old & new methods
data to demonstrate compliance . For example , the introduction of extractables and leachables testing has enhanced the process of selecting compliant packaging materials and the compatibility testing of materials . The identification and quantification of unknown impurities above the threshold is a regulatory requirement . HPLCs and GCs coupled with MS-MS detectors provide greater sensitivity in identifying and quantifying unknown impurities . Among many other benefits , new technologies help to remove regulatory burden by meeting the requirements of ne guidelines , such as Quality by Design ( QbD ), elemental impurities and data integrity requirements . Innovations in analytical chemistry can be particularly valuable in R & D when selecting stable and effective forms of drug substances . For example , solubility is a key challenge during drug development and analytical techniques can be used to determine the most compatible excipients to assist with this challenge . Drug-excipient compatibility studies using differential scanning calorimetry and thermogravimetric analysis provide valuable information in selection of excipients . For the development of oral solid dosage forms , various automatic dissolution ‣
29