Mallinckrodt, Inc.

Other

Narciso Ocampo Doran, Iii

David H White

Mills T Kneller

Thomas J Dunn

Michelle M Jones

Youlin Lin

David M Wong

Allan R Bailey

Process for producing ioversol

The present invention discloses a new process for producing ioversol (marketed as OPTIRAY.RTM.) comprising:

An improved process for the reversed phase chromatographic decolorization, separation, and purification of water-soluble, nonionic contrast media compounds from solutions containing nonionic compound impurities involves the steps of (a) packing a chromatographic column with a chromatographic packing material; (b) passing through the column a solution containing a water-soluble, nonionic contrast media compound and nonionic compounds as impurities at a loading ratio between approximately 10 to 1 and 1.5 to 1 wt. packing material/total wt. nonionic compounds; and (c) eluting the column to produce an eluate containing substantially pure, water-soluble, nonionic contrast media compound or MRI agent. The process can be economically practiced on a factory scale and efficiently removes non-polar impurities difficult to remove by conventional methods.

Reversed phase chromatographic process

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Bridgeton, MO, United States of America

Narciso Ocampo Doran, Iii