Purified TSH formulation, process for its preparation and its use in the production of TSH tracers for TSH receptor assay and in TSH receptor assay

摘要

TSH preparation which is obtained by purification of crude bovine TSH (thyrotropin), can be converted by direct radioiodination into a radioiodinated TSH tracer for a TSH receptor assay, has a biological activity of more than 40 IU TSH/mg protein and is obtainable by purification of commercial crude bovine TSH by affinity chromatography over an anti-TSH antibody column and subsequent ion exchange chromatography over a weakly acidic cation exchanger having terminal carboxyl groups and based on a polyamide-coated silica gel, a corresponding process for its production and its use for the production of a TSH tracer, in particular for a TSH receptor autoantibody assay.