Page 46 - Catalogue 2015

HEADSPACE
GRADE SOLVENTS

For Analysis of Organic Volatile Impurities

Organic Volatile Impurities (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 International Conference on Harmonization (ICH) Q3C, United States Pharmacopoeia
(USP) <467> and the European Pharmacopoeia (EP) 2.4.24, have set guidelines to
identify residual solvents in pharmaceuticals and ensure that these solvents are not above
the concentration limits according to the risk they pose for human health.

Revised procedures for the identification and quantification of OVI’s consist of
Headspace extraction coupled with a Gas Chromatographic (GC) separation. This
technique is a precise and well-accepted method for the analysis of residual solvents.

We offer a range of high boiling point solvents, such as Dimethylacetamide (DMA),
Dimethylformamide (DMF), Dimethylimidazolidinone (DMI), Dimethylsulfoxide (DMSO) and
N-Methyl-2-pyrrolidone (NMP), specially developed and packed for Headspace analysis of
volatile solvent impurities.
The purity of our Headspace grade solvents specifically evaluated by analysis against
standards to ensure the absence of interfering peaks in the GC chromatogram.