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VALIDATION OF KRISHZYME FACTOR IIa CHROMOGENIC ASSAY FOR TESTING OF TINZAPARIN AND TINZAPARIN INJECTION
EP26519
VALIDATION OF KRISHZYME FACTOR IIa CHROMOGENIC ASSAY FOR TESTING OF TINZAPARIN AND TINZAPARIN INJECTION
Submitted on 05 Oct 2017

DR AMITABHA DE
KRISHGEN BIOSYSTEMS
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Poster Abstract
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
accountsfor 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.Report abuse »
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