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Dionex Demonstrates New Method that Meets U.S. Pharmacopeia Criteria for Determination of N-Methylpyrrolidine in Cefepime

Dionex is proud to announce a new method that successfully determines N-methylpyrrolidine (NMP), a cefepime decomposition product, using an ICS-2100 system and IonPac® SCS1 column set coupled with nonsuppressed conductivity detection. Application Note 259: Determination of N-Methylpyrrolidine in Cefepime with Nonsuppressed Conductivity documents results for limit of detection, limit of quantification, linear calibration range, spike recovery, retention time Detection precision, and peak area precision determinations, thereby demonstrating that this instrumental configuration fulfills U.S. Pharmacopeia (USP) acceptance criteria for determining NMP in cefepime hydrochloride and Cefepime for Injection samples.

The cefepime antibiotic can degrade under certain thermal conditions, producing NMP, which can reduce cefepime potency and present potential toxicity to patients. The USP has proposed improved compendial methods for determining the limit of NMP in cefepime hydrochloride and Cefepime for Injection by eliminating column rinse and re-equilibration steps, thus increasing sample throughput. This new approach meets the USP proposed methods and criteria for Organic Impurities, Procedure 1 (Limit of N-Methylpyrrolidine).

Dionex (NASDAQ:DNEX) is a global leader in the manufacturing and marketing of liquid chromatography and sample preparation systems, consumables, and software for chemical analysis. The company's systems are used worldwide in environmental analysis and by the life sciences, chemical, petrochemical, food and beverage, power generation, and electronics industries. Our expertise in applications and instrumentation helps analytical scientists to evaluate and develop pharmaceuticals, establish environmental regulations, and produce better industrial products.

IonPac is a registered trademark of Dionex Corporation.



 

 

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