publication . Article . 2018

Comparison of the State Pharmacopoeia, XIII edition and the European Pharmacopoeia requirements for human plasma products

A. V. Karyakin; E. D. Skotselyas;
Open Access Russian
  • Published: 01 Feb 2018 Journal: Ведомости Научного центра экспертизы средств медицинского применения (issn: 1991-2919, eissn: 2619-1172, Copyright policy)
  • Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”
Russian requirements for main products derived from human plasma used to be laid out in several nonintegrated monographs that have been recently included into the State Pharmacopoeia of the Russian Federation, XIII edition. The present article compares requirements for the quality of human plasma products that are contained in the State Pharmacopoeia, XIII edition and in the European Pharmacopoeia.
free text keywords: государственная фармакопея, европейская фармакопея, фармакопейные статьи, препараты из плазмы крови человека, плазма для фракционирования, альбумин, иммуноглобулины, факторы свертывания крови, методы контроля качества препаратов крови, state pharmacopoeia, european pharmacopoeia, pharmacopoeial monographs, human plasma products, plasma for fractionation, albumin, immunoglobulins, blood-coagulation factors, methods of blood products quality control, Medicine (General), R5-920
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