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Simple, Rugged, and Accurate New Method for the Assay of Risedronate in Drugs

Thermo Fisher ScientificThermo Fisher Scientific Inc. is pleased to announce a new method that exceeds the U.S. Pharmacopeia (USP) monograph specifications for risedronate sodium analysis. This method is based on an anion-exchange separation with a 4 × 250 mm Thermo Scientific Dionex IonPac AS7 (USP L48) column using edetate disodium (EDTA) eluent to resolve risedronate from related compounds. Application Note 289: Evaluation of the USP Risedronate Sodium Assay demonstrates the linearity, detection limits, precision, and accuracy of the assayed amount of risedronate in the drug substance and drug product (Actonel, 35 mg tablets). The results of this study show the method to be simple, rugged, and accurate, thus making it suitable for use by quality control labs to ensure that the drug meets approved specifications.

The test results of this new method meet or exceed the USP monograph specifications for each tested variable in the range. The method separates risedronate in <15 min, leaving it well resolved from related compounds A and C. This study also proves method ruggedness by varying the column temperature, eluent pH, and using different Dionex IonPacTM AS7 columns from the same lot.

This application note and many others can be found at www.thermoscientific.com/dionex under the Documents tab.

About Thermo Fisher Scientific


Thermo Fisher Scientific Inc. is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of nearly $11 billion, we have approximately 37,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through two premier brands, Thermo Scientific and Fisher Scientific, which offer a unique combination of continuous technology development and the most convenient purchasing options. Our products and services help accelerate the pace of scientific discovery, and solve analytical challenges ranging from complex research to routine testing to field applications. Visit www.thermofisher.com.

All trademarks are the property of Thermo Fisher Scientific Inc. and its subsidiaries.


 

 

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