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In 2011, the U.S. Pharmacopeia (USP) conducted a survey of the international pharmaceutical industry to evaluate existing procedures for the identification of ions and counterions in drug salts. After finding that spectrophotometric tests were the method most commonly being used, the USP undertook an initiative to modernize existing monographs across all compendia. Survey respondents preferred instrumental tests rather than traditional wet-chemistry tests, and expressed an interest in clarification of procedures and acceptance criteria. In addition to meeting these needs, modernizing the monographs will facilitate harmonizing tests with other pharmacopeias, and will enable more rigorous identification tests to decrease adulteration and counterfeiting of drugs.
Existing assays are time consuming, labor-intensive, involve hazardous chemicals, require extensive analyst training, and may yield significant measurement errors. Ion chromatography (IC) offers a significant improvement to these assays, offering the following advantages:
When it comes to IC instrumentation there are a range of technologies available for pharmaceutical applications, including:
On either system you'll also save time and improve reproducibility with precise, automatic mobile phase generation and sample preparation.
Speak to a Sales Specialist about Pharmacopeial Modernization
Learn the basics of ion chromatography, including an introduction to the Dionex Integrion HPIC system.
This whiteboard video discusses the role of eluents and eluent generation in separating compounds via ion chromatography.
In this webcast, we will discuss the role of IC in USP monograph modernization, including the presentation of selected case studies where IC has been successfully adopted for monograph modernization.
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