Headspace Grade Solvents for the Analysis of ‘Organic Volatile Impurities’ (OVI’s)

OVI’s in pharmaceuticals, commonly referred as residual solvents, are trace organic volatile chemicals used or produced in the manufacturing of active substances, excipients, or in the preparation of medicinal products.

The solvent of choice is usually a critical parameter in the synthetic process, but since most of these solvents are not completely removed by practical manufacturing techniques, their content should be evaluated and justified.

In general identification and quantification of OVI's is conducted via Headspace- GC/FID. Guidelines for this procedure are set by the International Conference on Harmonization (ICH) method Q3C1, US Pharmacopoeia (USP) method 467 2, and the European Pharmacopoeia (EP) method 2.4.24 3.

Biosolve Headspace grade solvents are purified for the detection of OVI’s with the Headspace-GC technique. Products as DMA, DMF, DMI & DMSO are suitable as dissolution solvents for the analysis of OVI’s and show no major interference peaks in the elution range of common residual solvents.

Biosolve Headspace solvents: the preferred choice for the Analysis of ‘Organic Volatile Impurities’.