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US 2017/0370887 A1Published application
System and method for rapid analysis of polymer additives
AssigneeWaters Technologies Corporation
InventorsStephane Dubant, Baiba Cabovska, Andrew Aubin, Michael Jones, Peter Hancock
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Abstract
The subject technology is directed to a CO2-based chromatography system and method for rapid determination of the levels and/or the presence or absence of polymer additives (PAs) leachable or extractable from packing materials or implantable medical devices.
Claims23
A method for detecting one or more polymer additives (PAs) in a sample by means of a CO2-based chromatography analysis comprising:
- providing a sample comprising one or more PAs for analysis;
- wherein the sample is prepared with, extracted or dissolved in a diluent comprising at least 60% organic solvent, with the proviso that the sample is analyzed without a solvent exchange step;
- applying the sample to a chromatography column with a solid stationary phase comprising silica particles having a mean particle size of about 0.5 to about 3.5 microns;
- eluting the one or more PAs from the chromatography column by a mobile phase comprising a mixture of liquid CO2 and a modifier to form one or more eluted PAs, wherein the mobile phase has dwell volume of about 75 μL to about 500 μL;
- and
- detecting said one or more eluted PAs.
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3-5. (canceled)
9-13. (canceled)
A method for detecting one or more PAs comprising:
- (1) providing a sample comprising one or more PAs for analysis;
- wherein the sample is prepared with, extracted or dissolved in a diluent comprising at least 60% organic solvent, with the proviso that the sample is not subject to a solvent exchange step;
- (2) applying the sample to a chromatography system comprising:
- (a) a column with a solid stationary phase comprising silica particles having a mean particle size of about 0.5 to about 3.5 microns, wherein said column has a length of about 50 to 150 mm and an internal diameter about 2 to 4 mm, and wherein the solid stationary phase retains said one or more PAs;
- (b) a pre-column mobile phase dwell volume of about 75 μL to about 500 μL;
- wherein said pre-column dwell volume comprises a volume within a fluidic connection between a junction at which two or more mobile phase solvents including CO2 and a modifier are mixed to the head of the column;
- and
- (c) a post-column mobile phase dwell volume of about 10 μL to about 450 μL;
- wherein said pose-column dwell volume comprises a volume within a tubular connection between the end of the column and a detector;
- (3) eluting the one or more PAs from the chromatography column by a mobile phase comprising a mixture of CO2 and a modifier to form one or more eluted PAs, wherein the mobile phase has a flow rate of about 1 to 4 mL/min;
- and
- (4) detecting said one or more eluted PAs.
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A kit for performing analysis or detecting one or more PAs in a sample comprising:
- a sample preparation device for preparing the sample comprising one or more PAs for analysis;
- wherein the sample is prepared with, extracted or dissolved in a diluent comprising at least about 60% organic solvent, with the proviso that the sample is analyzed without a solvent exchange step;
- a chromatography column with a solid stationary phase comprising silica particles having a mean particle size of 0.5 to 3.5 microns;
- and
- one or more standards for calibrating and facilitating the analysis and detection of the one or more PAs.
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Dependencies are inferred from the claim text.