Top content published this week include a panel discussion with five SpecAcademy instructors and a feature article on Fourier transform infrared (FT-IR) spectroscopy.
|Articles|August 9, 2021
U.S. Food and Drug Administration Issues NIR Guidance
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On August 6, 2021, the U.S. Food and Drug Administration (FDA) released
The new guidance provides the agency’s recommendations for the development, validation, and use of NIR-based analytical procedures in evaluating a drug product’s identity, strength, quality, purity, and potency. The recommendations address the application of concepts described in FDA and International Council for Harmonization guidelines to NIR analytical procedures that use chemometric models. It also discusses submitting NIR documentation in applications.
The guidance does not discuss the development and validation of NIR analytical procedures or the setup, qualification, maintenance, or calibration of NIR instruments. The concepts of the guidance can be applied to other analytical technologies.
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In this Q&A, we provide an overview of what the latest “What’s Nu” covered, which includes new research in environmental analysis and clinical analysis.
How has spectroscopy training changed? A recent panel discussion explored this topic, discussing how SpecAcademy can widen access without losing the value of hands-on instruction.
How has spectroscopy education evolved over the years?
FT-IR spectroscopy, long treated as a mature bench technique for confirming a carbonyl stretch or fingerprinting a polymer, has quietly become one of chemistry’s most versatile discovery engines: it now infers molecular structure straight from a spectrum without a reference library, resolves chemistry tens of nanometers wide, and screens a fingerstick of blood for disease in minutes. The last five years of published research show FT-IR moving from a confirmatory tool into a predictive, autonomous, and field-ready analytical platform.
In this panel discussion, five SpecAcademy instructors examined why spectroscopy expertise has declined and how SpecAcademy aims to rebuild it through curated, fundamentals-based education suited to increasingly complex analytical work.
A recent roundtable discussion with the SpecAcademy instructors explored why spectroscopy expertise has eroded and how SpecAcademy aims to rebuild it.
The agreement gives North American customers a stocked, domestic source for InGaAs PIN photodiodes and avalanche photodiodes from the Scottish manufacturer.
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