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International collaborative study for the calibration of the Ph. Eur. somatropin chemical reference substance batches 3 and 4 (BSP108).
- Source :
-
Pharmeuropa bio & scientific notes [Pharmeur Bio Sci Notes] 2013; Vol. 2013, pp. 1-39. - Publication Year :
- 2013
-
Abstract
- An international collaborative study was carried out for the establishment of replacement batches for the European Pharmacopoeia (Ph. Eur.) Somatropin Chemical Reference Substance (CRS) batch 2. The study was organised within the framework of the Biological Standardisation Programme (BSP) of the Council of Europe and the European Commission. Seventeen laboratories from Europe, North America, South America and Australia took part in the collaborative study. The study aimed at calibrating the somatropin content of 2 candidate preparations and demonstrating their suitability to serve as a reference substance in the tests for identification, for related proteins, for dimers and related substances of higher molecular mass (HMM), for charged variants distribution and for the assay of somatropin, as prescribed by the current Ph. Eur. monographs 0950 Somatropin bulk solution, 0951 Somatropin and 0952 Somatropin for injection. Based on the results summarised herein the Ph. Eur. Commission adopted in January 2012 candidate preparation b (cCRS-b, Sample D) as somatropin CRS batch 3 with an assigned content of 3.86 mg of somatropin monomer per vial, and candidate preparation a (cCRS-a, Sample C) as somatropin CRS batch 4 with an assigned content of 2.59 mg of somatropin monomer per vial.
- Subjects :
- Australia
Calibration
Chromatography, Gel
Chromatography, Reverse-Phase
Drug Stability
Electrophoresis, Capillary
Europe
North America
Protein Multimerization
Reference Standards
South America
Drugs, Investigational chemistry
Drugs, Investigational standards
Growth Hormone chemistry
Growth Hormone standards
International Cooperation
Pharmacopoeias as Topic
Technology, Pharmaceutical standards
Subjects
Details
- Language :
- English
- ISSN :
- 2075-2504
- Volume :
- 2013
- Database :
- MEDLINE
- Journal :
- Pharmeuropa bio & scientific notes
- Publication Type :
- Academic Journal
- Accession number :
- 23380508