Simplified and Reproducible Separation of Ethyl Sulfate Impurity in Indinavir Sulfate

SUNNYVALE, Calif. (Nov 2011) — Thermo Fisher Scientific Inc. is pleased to announce a new method that uses ion chromatography (IC) to separate ethyl sulfate in an indinavir sulfate drug sample. Indinavir sulfate is a specific and potent inhibitor of HIV-1 protease and is widely used in the treatment of AIDS. Application Note 284: Determination of Ethyl Sulfate Impurity in Indinavir Sulfate Drug Using Ion Chromatography demonstrates that only the addition of deionized water to the IC system is required to deliver reproducible chromatography while avoiding the time, labor, and potential error of manual eluent preparation. This method uses an electrolytic suppressor in recycle mode, and therefore, does not require the analyst to prepare sulfuric acid solutions for eluent suppression.

Pharmaceutical companies can use the method described in AN 284 to monitor process-related and degradation impurities before commercial release to prove the consistency of their manufacturing process.

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