USP Modernization Initiative: Ionic Impurities in Drug Substances by Ion Chromatography
28 Nov 2018Chloride and sulfate are common impurities present in drug substances and drug products. Limit tests are based on turbidity and/or visual comparison methods as per USP general chapter. These methods lack specificity and data integrity. One of the main goals of the USP monograph modernization initiative is to replace non-specific methods with highly selective and sensitive instrumental analysis methods. We propose a selective and sensitive ion chromatography (IC) method for chloride and sulfate detection in drug substances, potassium carbonate and potassium bicarbonate. The proposed method can be used for other anionic impurities, such as fluoride, bromide, nitrate and nitrate, if needed.
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940 Professional IC Vario
Metrohm AGWith the 940 Professional IC Vario system, Metrohm sets a new standard in ion chromatography. 940 Professional IC Vario stands for maximum flexibility combined with most easy operation and perfect reliability. Entirely modular by design, the new 940 Professional IC Vario meets your particular requirements while keeping you perfectly flexible. Based on one and the same system, you can configure any IC system you want or need.All solutions – including standards – are produced fully automatically, if desired. Starting with sample injection, the system works completely autonomously. Moreover, it is self- monitoring: All system and method parameters are permanently checked; if any system component should require maintenance, the system tells you so – with a message in plain text.The 940 Professional IC Vario system provides superior reliability of both the system itself and the analytical results produced on it: Because the system is self-monitoring, operator errors are virtually ruled out. You can absolutely rely on your measuring results. Moreover, all results can be traced back to every single step of the analysis and even sample preparation. Thus, even the strictest audits are no reason to worry any more.940 Professional IC Vario Features: Modular high-performance ion chromatography system. Unlimited possibilities for system configuration. Compact dimensions, small footprint. For routine analyses and research applications in the ng/L- to %-range. Highest sensitivity for lowest detection limits. Intelligent system components for reliable results. Wide range of detection options: conductivity, UV/VIS, amperometry, ... Free choice of suppressor and column. All gradient options. Inline eluent preparation integrated in the system. Multi-language MagIC Net software for intuitive and simple operation. Complies with GLP and the FDA regulations. Compatible with the unique and partly patented Metrohm Inline Sample Preparation techniques (MISP). Complete automation for high sample throughput. Low maintenance costs and long lifetime. Rugged Swiss quality.