Regardless if the extraction study is on a pharmaceutical container closure system, single use manufacturing equipment or a medical device, the sample extracts need to be analyzed by analytical techniques that can scout for the presence of extractables, identify the observed extractables, and determine semi-quantitative levels of the detected extractables. While many different analytical techniques could be used, the most common and best suited for the task are the following four techniques:

• Headspace GC-MS for the analysis of volatile organic extractables

• Direct inject GC-MS for the analysis of semi-volatile organic extractables

• LC-QToF for the analysis of non-volatile organic extractables

• ICP-MS for inorganic extractables

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