Waters Technologies Corporation

Jennifer Simeone

Matthew A Lauber

Amit Patel

Kevin Daniel Wyndham

Moon Chul Jung

Mathew H DeLano

Thomas H Walter

Paula Hong

Mathew Delano

The present disclosure is directed to a kit for evaluating system inertness. The kit includes a positive control comprising a metal interacting moiety, and a negative control that does not contain a metal interacting moiety. In some embodiments the kit also includes a container to hold a system suitability solution (e.g., an equimolar mixture of the positive control and the negative control).

Compounds for use in system suitability testing of inert LC systems and columns

The present disclosure is directed to methods of characterizing a system containing a chromatographic column. The methods can include introducing a sample comprising a positive control and a negative control to the system containing a chromatographic column, wherein the positive control is a sensitive probe that interacts with the system and the negative control is substantially non-interacting with the system; after passing the sample through the chromatographic column, detecting the positive control and the negative control; and determining system suitability by comparing the amount of detected positive control to negative control. In some embodiments, determining system suitability (e.g., inertness of sample to the system) is accomplished by determining a ratio of detected positive control to negative control.

Techniques for system suitability testing of inert liquid chromatography systems and columns

The present disclosure is directed to methods for evaluating system inertness, such as the inertness of a LC or other fluidic system. Some methods are directed to tests wherein the column has been removed prior to injecting a sample including a positive (e.g., metal reacting moiety) control into the system. Some methods can include: (1) repeatedly injecting the sample into a system, the system comprising: fluidic paths wherein interior surfaces of the fluidic paths define wetted surfaces, and wherein at least a portion of the wetted surfaces of the fluidic flow path are coated with an inert coating, wherein the inert coating is inert to at least one analyte in the sample; (2) detecting a value associated with the positive control; and (3) analyzing values associated with the detected positive control to determine system inertness.

Methods for the evaluation of system inertness

The present disclosure generally relates to methods for separating ondansetron and related impurities using CO-based chromatography.

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Shrewsbury, MA, United States of America

Jennifer Simeone