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Validation of KRISHZYME Factor IIa Chromogenic Assay for Testing of Tinzaparin and Tinzaparin Injection

The inhibitory effect of anti-thrombin III (AT-III) on thrombin, factor IIa and other coagulation serine proteases in plasma is increased several thousand-fold by Tinzaparin. This inhibition accounts for the anticoagulant effect of Tinzaparin.

The quantitative determination of Tinzaparin levels by the measurement of their anti-IIa activity is a necessary tool for monitoring treatment efficacy.

Presence of Tinzaparin catalyzes the reaction between factor IIa and AT-III. The factor IIa inhibition test is the most useful assay covering the widest variety of Tinzaparin preparations.

In the assay, the rate of factor IIa inhibition is directly proportional to the Tinzaparin concentration since both factor IIa and AT-III are in excess. The residual factor IIa activity is inversely proportional to the Tinzaparin concentration.

The assay was validated using Tinzaparin Sodium EPRS.

The assay kits manufactured by KRISHGEN BIOSYSTEMS are validated Chromogenic Assays for the determination of Tinzaparin using anti-lla activity in human plasma successfully met all standard assay-validation parameters and were suitable for use in bioequivalence studies.