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Displaying 1-5 of 7 results for Tag: Active pharmaceutical ingredient

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AN262: Determination of 2-Ethylhexanoic Acid Impurity in Clavulanate

Instrument Type: IC

Clavulanic acid is a potent beta-lactamase inhibitor. 2-ethylhexanoic acid is a potential impurity. This work presents a simpler IC method using a Reagent-Free Ion Chromatography (RFIC) system with suppressed conductivity detection and IonPac AS11 column for the detection and quantification of 2-ethylhexanoic acid. Results for LOD/LOQ, linear calibration range, spike recovery, retention time precision, and peak area precision determinations show that IC is an accurate and reproducible technique to determine 2-ethylhexanoic acid in clavulanate below the 0.8% acceptance criteria.

Ternary Gradient for Tenofovir Disoproxil Fumarate Impurity Profiling

Instrument Type: UHPLC

The antiretroviral drug tenofovir is in formulation given as the prodrug tenofovir disoproxil fumarate (TDF) in combination with the nucleoside reverse-transcriptase inhibitor emtricitabine. Here we show the impurity profiling of an active pharmaceutical ingredient with the Thermo Scientfic Vanquish Flex UHPLC system. The simultaneous separation of early-eluting polar compounds and later-eluting nonpolar compounds is achieved by applying a ternary gradient with the quaternary Vanquish F pump using a Thermo Scientific Accucore aQ column.

AN148: Determination of Bethanechol by Ion Chromatography.

Instrument Type: IC

Bethanechol chloride is a quaternary ammonium compound that is structurally and pharmacologically related to acetylcholine. A method in the USP 24 NF 19 recently proposed that the gravimetric assay for bethanechol chloride be replaced with a more specific and rugged ion chromatography assay. The proposed method specifies the use of a Dionex IonPac CS14 separator column using methanesulfonic acid (MSA) eluent and suppressed conductivity detection. Here, we applied electrolytic on-line generation of MSA to optimize reproducibility, convenience, and method transfer between laboratories.

UHPLC Method for Analyzing a Once-Daily Tablet Formulation for HIV-1 Infection Treatment

Instrument Type: UHPLC

This application demonstrates the fast seaparation of four main compounds of the Stribild pill using the latest generation of UHPLC equipment. The highly efficient Thermo Scientific Accucore Vanquish C18+ column with 1.5 μm particles provides a fast separation of the main compounds and several impurities.

Improved analysis of active pharmaceutical ingredients in a pain-relief medicine using a Thermo Scientific Acclaim Mixed-Mode WAX-1 HPLC column

Instrument Type: HPLC

The Thermo Scientific HPLC system was applied for the analysis of active pharmaceutical ingredients (APIs) in a pain-relief medicine. The separation was performed on a Thermo Scientific Acclaim Mixed-Mode WAX-1 column with UV detection at 220 nm.