Materials Analysis - Cleanliness Testing Lab

Innovatech Labs, Inc.
13805 First Ave. North
Suite 100
Plymouth, MN 55441

Phone (763) 231-0150
Fax (763) 231-0151
Toll free: (888) 740-5227

home > applications > residual solvents in drugs

Residual Solvents in Drugs

Technique Used: Static Headspace coupled with GC/MS

A pharmaceutical manufacturer wanted to know whether a solvent (ethanol) used in their process was present in a powdered drug. Static headspace and gas chromatography/mass spectrometry (GC/MS) were used to identify and quantify the amount of any ethanol present. The resultant gas chromatogram of the drug (top figure) shows a possible solvent peak at a retention time of approximately 1.67 min. The peak is positively identified as ethanol from its mass spectrum (bottom figure). The amount of ethanol was quantified using a one-point standard.

Gas Chromatogram Test Results of Drug

GC/MS Test Results Identify Ethanol in Drug

Innovatech Labs offers a broad range of cleanliness testing, surface analytical techniques, organic spectroscopies, bulk testing methods, and consulting services. Contact us for more information.