Certification of the branch standard sample of anti-alpha-staphylolysin content, and some aspects of its use
Abstract
Keywords
About the Authors
E. A. KhusnatdinovaRussian Federation
1st professional category expert of the Laboratory of Immunoglobulins and Blood Products of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Biological Sciences
E. S. Konovalova
Russian Federation
2nd professional category expert of the Laboratory of Immunoglobulins and Blood Products of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality
O. V. Fadeykina
Russian Federation
V. Chief technologist of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Biological Sciences
R. A. Volkova
Russian Federation
Head of the Laboratory of Molecular Biology and Genetic Test Methods of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Doctor of Biological Sciences
N. I. Kishkurno
Russian Federation
Senior intellectual property specialist of the Department for Editorial and Publishing Activities and Intellectual Property Protection of the Centre for Planning and Coordination of Scientific Activities
E. Yu. Kudasheva
Russian Federation
Head of the Laboratory of Immunoglobulins and Blood Products of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Medical Sciences
D. V. Shvedov
Russian Federation
Deputy head of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Medical Sciences
References
1. Immunoglobulin for human use. Report of the WHO Expert Committee. WHO, Series of Technical Reports ¹ 327. Geneva, 1968.
2. Volkova RA, Fadeikina OV, Klimov VI, Sakanyan EI, Olefir YuV, Merkulov VA et al. Topical issues related to reference standards in the sphere of circulation of biological products. BIOpreparations. Prevention, Diagnosis, Treatment 2016; 16(4): 229–36 (in Russian).
3. Mironov AN, Sakaeva IV, Sakanyan EI, Bunyatyan ND, Kovaleva EL, Mitkina LI et al. Reference standards in international and domestic pharmaceutical analysis. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products 2012; (3): 56–60 (in Russian).
4. FS. 3.3.1.0005.15. Anatoxin staphylococcal purified adsorbed, suspension for subcutaneous administration. State Pharmacopoeia of the Russian Federation. 13th ed. V. 3. P. 809–16. Available from: http://www.femb.ru/feml (in Russian).
5. FS. 3.3.1.0006.15. Staphylococcal anaphylaxis purified, solution for subcutaneous administration. State Pharmacopoeia of the Russian Federation. 13th ed. V. 3. P. 817–25. Available from: http://www.femb.ru/feml (in Russian).
6. Staphylococcus-alpha antitoxin, equine. Lyophilized, 220 IU. 3rd International Standard. WHO International Biological Reference Preparations. 2017. P. 21. Available from: http://www.who.int/ bloodproducts/ref materials/.
7. OFS. 1.8.2.0008.15. Determination of the content of anti-alpha-staphylolysin (specific antibodies) in medicinal preparations from human and animal blood serum. State Pharmacopoeia of the Russian Federation. 13th ed. V. 2. P. 949–58. Available from: http://www.femb.ru/feml (in Russian).
8. Glantz SA. Primer of Biostatistics. Moscow: Praktika; 1999 (in Russian).
9. Scientific and technical products. Realization of strains and industry standard samples of FSBI «SCEEMP» of the Ministry of Health of Russia. Available from: http://www.regmed.ru/content/page/ EXPERTISE_Strains_Purchase (in Russian).
10. Decree of the Chief State Doctor of the Russian Federation of February 17, 2016 ¹ 19 «On the approval of sanitary and epidemiological rules SP 3.3.2.3332-16 Conditions for the transport and storage of immunobiological medicinal products» (in Russian).
Review
For citations:
Khusnatdinova E.A., Konovalova E.S., Fadeykina O.V., Volkova R.A., Kishkurno N.I., Kudasheva E.Yu., Shvedov D.V. Certification of the branch standard sample of anti-alpha-staphylolysin content, and some aspects of its use. BIOpreparations. Prevention, Diagnosis, Treatment. 2017;17(4):248-252. (In Russ.)