Validation of the method for determination of prekallikrein activator in Human Albumin

• Main Authors: M. V. Tomilin, E. V. Filatova, M. M. Kuznetsova, V. V. Sudakova, N. V. Zubkova
• Format: Article
• Language: Russian
• Published: Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2018-02-01
• Series: Биопрепараты: Профилактика, диагностика, лечение
• Subjects: альбумин; активатор прекалликреина; валидация; метрологические характеристики; препараты крови; albumin; prekallikrein activator (pka); validation; the metrological characteristics; blood products
• Online Access: https://www.biopreparations.ru/jour/article/view/83

Prekallikrein activator (PKA) is regarded as one of the most important factors determining the safety of blood products such as albumin and intravenous immunoglobulin. PKA impurity at a high concentration may cause undesired side effects when administered to patients of blood products. According to requirements of the State Pharmacopoeia of the Russian Federation (13th edition) human albumin preparations have to pass test for the quantitative determination of prekallikrein activator (PKA), but there is no description of the method. The purpose of this study consisted in validation of a method of the quantitative definition of PKA in the preparations Albumin (human albumin) solution for infusions 10 % and 20 % with use of the commercial kit PreKallikrein Activator Assay Kit PW301EP («Pathway Diagnostics Ltd», UK). It is established that the method is accurate, linear, high-precision and specific. The method is characterized by the simplicity of the experiment, high accuracy and reproducibility that can be used in terms of control and analytical laboratories. It is shown that in all investigated batches of the drug Albumin (human albumin) solution for infusion 10 % and 20 % PKA content was less than 1 IU/ml, which corresponds to the requirements of the State Pharmacopoeia of the Russian Federation to these drugs.