The Challenge

USP 467 is a General Chapter in the USP Pharmacopeia that regulates content and analysis of residual solvents in pharmaceutical preparations. Residual solvents in pharmaceuticals are used or produced in the manufacture of drug substances or excipients, or in the preparation of drug products. The residual solvents are not completely removed by practical manufacturing techniques. Appropriate selection of the solvent for the synthesis of a drug substance or an excipient may enhance the yield, or determine characteristics such as crystal form, purity, and solubility. Therefore, the solvent may sometimes be a critical element in the synthetic process.

Analysis of residual solvent is typically carried out by headspace-gas chromatography using FID detection (single or dual configuration). Other detectors like mass spectrometers can also be used. Headspace-gas chromatography is the recommended technology, however any analytical approach can be used for residual solvent analysis, providing that the method is validated and provides results comparable with the reference method by HS-GC. So, in any case, at least in the method development stage, a HS-GC analysis has to be performed.

The Solution

The DANI USP 467 systems provide the best in class, efficient, easy-to-use and compliant solution for those companies  concerned about compliance with regulations for final commercial products. Lack of compliance might have severe repercussions on cash flow and profitability of these companies as well as creating delays for new products (drugs) introductions.

DANI provides integrated systems to operate USP 467 in a fully compliant manner. The systems are based on proprietary technologies in headspace sampling and gas chromatography and can accommodate different pre-existing workflows already established at customers’ facilities. Specific configurations with proprietary mass spectrometry detection are also available.



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