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With the increasing global trade in pharmaceuticals there are major industry concerns regarding distribution of counterfeit drugs and patient safety. There is a requirement for rapid and cost-effective counterfeit drug screening methods. Intertek supports pharmaceutical clients by applying NMR technology to identify and quantify active pharmaceutical ingredients (APIs) in drug products.
NMR Screening Methodology:
Methodology typically involves solvent extraction and quantification using appropriate internal standards. These methods which are applied without detailed product specific validation, have highlighted cases where APIs were completely absent from the product and instances where the API levels were at major variance from the stated dose. When issues such as these are identified through screening, it is then important to validate methods before investigating further.
NMR Analysis Services:
The Intertek ASG research laboratory provides advanced capabilities in NMR. State-of-the-art instrumentation combined with experienced scientists that can interpret and design advanced experiments allows Intertek to offer a first rate solution to troubleshooting and complex scientific investigations. The NMR team provides a highly efficient service, including an overnight service with access to automatic web-enabled analytical results via a secure server (similar MS services are also available). The instruments are qualified to both GLP and cGMP standards, enabling NMR data to be used in regulatory projects and pharmaceutical QC.
Request more information to see how Intertek can help your organization with NMR Analysis for Counterfeit Drugs.
