Development of Pharmacopoeial Methods for Determining the Anticomplementary Activity of Human Immunoglobulin Preparations
The development of a pharmacopoeial method for determining the anticomplementary activity of human immunoglobulin preparations was reviewed. It was shown that the methods for determining anticomplementary activity that are used by domestic manufacturers of human immunoglobulin preparations did not c...
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| Published in | Pharmaceutical chemistry journal Vol. 50; no. 5; pp. 328 - 330 |
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| Main Authors | , , , |
| Format | Journal Article |
| Language | English |
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Springer US
01.08.2016
Springer |
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| Abstract | The development of a pharmacopoeial method for determining the anticomplementary activity of human immunoglobulin preparations was reviewed. It was shown that the methods for determining anticomplementary activity that are used by domestic manufacturers of human immunoglobulin preparations did not comply with current international requirements, primarily because a standard sample was not used. The general pharmacopoeial monograph “Determination of anticomplementary activity of human immunoglobulin preparations for intravenous administration” that was published in the Russian Federation State Pharmacopoeia, XIIIth Edition, was formulated for the first time as a result of optimizing the conditions for determining anticomplementary activity and harmonization of the method with major foreign pharmacopoeias. |
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| AbstractList | The development of a pharmacopoeial method for determining the anticomplementary activity of human immunoglobulin preparations was reviewed. It was shown that the methods for determining anticomplementary activity that are used by domestic manufacturers of human immunoglobulin preparations did not comply with current international requirements, primarily because a standard sample was not used. The general pharmacopoeial monograph “Determination of anticomplementary activity of human immunoglobulin preparations for intravenous administration” that was published in the Russian Federation State Pharmacopoeia, XIIIth Edition, was formulated for the first time as a result of optimizing the conditions for determining anticomplementary activity and harmonization of the method with major foreign pharmacopoeias. |
| Audience | Academic |
| Author | Bunyatyan, N. D. Krivykh, M. A. Kornilova, O. G. Kudasheva, E. Yu |
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| Copyright | Springer Science+Business Media New York 2016 COPYRIGHT 2016 Springer |
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| Keywords | human immunoglobulin pharmacopoeia anticomplementary activity harmonization standard sample |
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| References | State Pharmacopoeia of the Republic of Kazakhstan, Vol. 2, Izd. Dom Zhibek Zholy, Almaty (2009), p. 804. The Japanese Pharmacopeia, 6thEd., Pharmaceuticals and Medical Devices Agency (2011). State Pharmacopoeia of the Republic of Belarus, 1stEd., UP Center of Expertise and Testing in Healthcare, Minsk (2006), p. 1345. European Pharmacopoeia, 8.5 Ed.; URL: http://online6.edqm.eu/ep801/(accession date Aug. 21, 2015). USSR State Pharmacopoeia [in Russian], 9thEd., Meditsina, Moscow (1961). General Pharmacopoeial Monograph “Determination of anticomplementary activity of human immunoglobulin preparations for intravenous administration” (OFS. 1.8.2.0007.15); URL: http://193.232.7.120/fem1/clinicalref/pharmacopoeia2/HTML/#937/z (accession date Nov. 7, 2015). Determination of anticomplementary activity of immunoglobulin preparations for intravenous administration: Methodical instructions [in Russian], MUK 3.3.2.1063 – 01, Federal State Sanitary and Epidemiology Center of the RF Ministry of Health, Moscow (2001), pp. 1 – 16. USP 38-NF33, The United States Pharmacopeial Convention; URL: http://www.uspnf.com/uspnf/pub/index?usp-38&nf=33&s=1&officialOn=August2015 (accession date Aug. 21, 2015). USSR State Pharmacopoeia [in Russian], 10thEd., Meditsina, Moscow (1968). BuchacherASchlugaPMullnerJVox Sang.20109820921810.1111/j.1423-0410.2009.01271.x RamasamyITranEFarrugiaABiologicals199725187921:CAS:528:DyaK2sXjvVyjtb8%3D10.1006/biol.1996.00639167012 M. A. Krivykh, O. G. Kornilova, N. D. Bunyatyan, et al., Khim.-farm. Zh., 49(7), 39 – 42 (2015); Pharm. Chem. J., 49(7), 473 – 476 (2015). British Pharmacopoeia, C 2, Test for anticomplementary activity of immunoglobulin (Appendix XIV, J. Blood and Related Products), British Pharmacopoeia Commission, Vol. IV (2013). Determination of anticomplementary activity of immunoglobulin preparations, Methodical recommendations [in Russian], MH RSFSR, Gorkii (1988), pp. 1 – 12. Indian Pharmacopoeia, Human Normal Immunoglobulin for Intravenous Use, Vol. 111 (2010), pp. 2579 – 2586. I Ramasamy (1446_CR4) 1997; 25 cr-split#-1446_CR14.2 1446_CR9 cr-split#-1446_CR14.1 A Buchacher (1446_CR3) 2010; 98 1446_CR7 1446_CR12 1446_CR8 1446_CR13 1446_CR5 1446_CR10 1446_CR6 1446_CR11 1446_CR1 1446_CR2 1446_CR15 |
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| SubjectTerms | Immunoglobulins Medicine Organic Chemistry Pharmacology/Toxicology Pharmacy |
| Title | Development of Pharmacopoeial Methods for Determining the Anticomplementary Activity of Human Immunoglobulin Preparations |
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