Solvents are used in the manufacture of drug substances and excipients, as well as in the preparation of drug products. Solvents are also critical in various synthetic processes and may determine characteristics such as crystal form, purity, and solubility. Solvents do not provide any therapeutic benefit; hence they should be removed as completely as possible to provide a high quality product and to fulfill international requirements.
Within USP <467> there are three classes of solvents, Class I – solvents to be avoided, Class II – solvents to be limited, and Class III – solvents of lower risk. The method for determination of Class I and II solvents is headspace gas chromatography; the determination of Class III solvents is performed with method <731> loss on drying.
This study will apply a single pressure balanced headspace method to the analysis of Class I, II, and III solvents in pharmaceutical products by USP method <467>. The analysis of solvents will be completed with a variety of diluents across a range of polarities, including: water, DMSO, DMI, DMF, NMP, and BA. The data presented will include signal to noise, resolution, and precision.
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