Analytical instrument vendors have made significant improvements in the sensitivity, resolution, and accuracy of their products. Many have also developed smaller versions of even the most complex instruments, reducing cost and increasing their applicability for day-to-day use. Methods such as nuclear magnetic resonance (NMR) spectroscopy and mass spectrometry (MS) are finding wider use for routine analyses as a result. These methods provide much greater levels of information than what has been possible using more traditional techniques.
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The growing use of techniques, such as MS and NMR, that produce large quantities of data, combined with the increasing sensitivity and accuracy of modern instruments and methods, presents challenges with respect to the manipulation and processing of analytical data. As a result, software platforms have become nearly as important as the analytical technologies themselves.[110] They are also essential for ensuring the traceability, security, and incorruptibility of scientific data.
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Process analytical technologies (PATs) provide real- or near-real-time data that can facilitate process development and enable monitoring of commercial API production processes. Ongoing access to such data allows for better process control and affords the ability to rapidly respond to changes in the process environment to prevent out-of-specification events.
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Nitrosamine impurities were first detected in APIs used in cardiovascular treatments in 2018. Since then, they have been found in APIs used to formulate diabetes medications and over-the- counter antacids, among other drug products. In 2020, both FDA and EMA issued guidelines on testing of both approved/marketed products and drug candidates. Both agencies recommended drug makers conduct risk analyses to determine which APIs might be likely to contain nitrosamine candidates (based on chemical structure, process conditions, excipients and so on). Those with a high risk had to be tested, and mitigation plans developed and implemented for any found to contain nitrosamine contaminants above newly set acceptable levels. FDA’s deadline for testing of drugs products for nitrosamine contaminants was initially October 1, 2023.[112]
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