USP <467> Headspace Residual Solvent Assay with a HT3™ Headspace Instrument

The US Pharmacopeia recently released USP<467> as the current monograph for determining residual solvents in pharmaceutical products by static headspace. The USP classified these residual solvents into 3 categories; Class 1, Class 2 and Class 3. This headspace method does not require further validation if the USP parameters are followed.

Following USP<467> monograph parameters, this study utilizes a Teledyne Tekmar HT3 Headspace Instrument (Figure 1) in the static mode, eliminating the need for extensive USP mandated method validation. The Class 1 compounds were evaluated from 50% to 500% of the USP limits. The Class 2 compounds were evaluated from 25% to 400% of the USP limits.

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