Bioresorbable polymers are increasingly utilized for implantable medical devices to avoid complications related to explant and/or long term responses to foreign materials. As with all polymeric materials, residual levels of unreacted monomer, and other volatiles, drastically affect the mechanical and chemical properties as well as the parameters required to process the material into a device. The 1,4-dioxane-2-one (PDO) monomer is a six membered ring that forms an ether-ester polymer via ring-opening polymerization (ROP) with intermediate absorption rate properties that are ideal for numerous implant situations. Developing devices using poly(1,4-dioxane-2-one) (PPDO, PDO, PDX, PPDX, or PDS) is complicated by residual levels of the unreacted, ring-form of the monomer causing the material to be toxic to biologic tissue in addition to the typical negative effects of excessive residual monomer in polymers, especially bioresorbable polymers. It is required to quantify the residual monomer content of PDO polymer throughout the manufacturing and storage of polymer or devices to ensure proper and repeatable processing in addition to the safety aspects related to the end use of the material. This work describes the application and comparison of known gas chromatography techniques, multiple headspace extraction and classical vaporization injection, to separate the residual monomer from the polymer matrix and allow for quantification. Accuracy and repeatability evaluations were used to determine the ideal testing methods to be used in industry as regulated by governing agencies such as the Food and Drug Administration (FDA)
