Comparison of the State Pharmacopoeia, XIII edition and the European Pharmacopoeia requirements for human plasma products
Abstract
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.
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
About the Authors
A. V. Karyakin
Hematology Research Center
Russian Federation
Russian Federation
E. D. Skotselyas
Hematology Research Center
Russian Federation
Russian Federation
References
1. Plasma for fractionation. FS 3.3.2.0001.15 (in Russian).
2. Human albumin. FS 3.3.2.0006.15 (in Russian).
3. Human immunoglobulin normal. FS 3.3.2.0007.15 (in Russian).
4. Human immunoglobulin normal intravenous. FS 3.3.2.0008.15 (in Russian).
5. The State Pharmacopoeia of the USSR. 11th ed. V. 1, 2. Moscow: Meditsina; 1987, 1990 (in Russian).
6. The State Pharmacopoeia of the Russian Federation. 12th ed. V. 1. Moscow: NCESMP; 2007 (in Russian).
7. European Pharmacopoeia. 8th edition. Strasbourg: EDQM; 2013.
8. Human Plasma for fractionation. Monograph Ph. Eur.8 0853 (in Russian).
9. Human Albumin solution. Monograph Ph. Eur.8 0255 (in Russian).
10. Human normal Immunoglobulin. Monograph Ph. Eur.8 0338 (in Russian).
11. Human normal Immunoglobulin for intravenous administration. Monograph Ph. Eur.8 0918 (in Russian).
12. Human von Willebrand factor. Monograph Ph. Eur.8 2298 (in Russian).
13. Human coagulation factor VII. Monograph Ph. Eur.8 1224 (in Russian).
14. Human coagulation factor VIII. Monograph Ph. Eur.8 0275 (in Russian).
15. Human coagulation factor IX. Monograph Ph. Eur.8 1223 (in Russian).
Review
For citations:
Karyakin A.V., Skotselyas E.D. Comparison of the State Pharmacopoeia, XIII edition and the European Pharmacopoeia requirements for human plasma products. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2016;(2):50-52. (In Russ.)
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