Quality assurance of synthetic peptides

Drugs Made in Germany

Volumn 43, Issue 1, 2000, Pages 13-20

[No Author Info available]

Author keywords

[No Author keywords available]

Indexed keywords

EID: 27144527852     PISSN: 00126683     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (30)

1. ICH Topic Q3A Note for Guidance on Impurities Testina: Impurities in New Drug Substances (CPMP/SCI1/142/95)
2. ICH topic Q3B Noie for Guidance on Impurities in New Medicinal Products (CPMP/ICH/282/95)
3. Kemp, D. S., Racemisation in Peptide Synthesis. Vol. 1, Chapter 7.
4. in: E. Gross. 1 Meienhofer (eels.). The Peptides: Analysis. Synthesis. Biology. Vol. i-9. Academic Press. New York 1975-1987
5. Frank. H. etal., J Chromatogr. 15, 174 (1977)
6. ICH Topic Q6A Note for Guidance on Specifications: Test Procedures and Acceptance Criteria for New Drue Products: Chemicai Substances. Step 3. Draft. 16 July 1997 (CPMP/1CH/367/96)
7. Lehmann. W. D.. Massenspektrometric in der Biochemie, p. 27Sf.. Spektrum Akademischer Veriag. Heidelberg (1996)
8. Kessler. H.. Griesineer. C.. Zarbock. I el al., I Magnet. Resonance 57, 331 (1984)
9. Kemp. D. S., Racernisalion in Peptide Synthesis. Vol. 1. Chapter 7;
10. Benoiton. N. L.. Quantitation and Sequence Dependence of Raccmisation in Peptide Synthesis. Voi. 5. S. 217;
11. in: E. Gross. J. Mcicnhofer (eds.). The Peptides: Analysis, Synthesis, Biology. Academic Press. New York 1975 1987
12. Gerhard. I. Maücher, 1, Peptides 1992. Proceedings of the 22nd European Peptide Symposium. Escom Leiden 1993. pp. 457-458;
13. Errncr. J.. Gerhardt, .L, Siewert, VI., Arch. Pharm. 328, 635 (1995)
14. Bischoff, R., Kolbe. M. V. J., J. Chromatosr. B 662, 261 (1994)
15. Olsen, B. A.. Baertschi, S.W., Riggin, R.M., 1 Chromatogr. 648. 165 (1993);
16. Ermer, J., J. Pharm. Biomed. Anal. 18, 707 (1998)
17. Korhammer, S. A.. Bernreuter, A., Fres. J. Anal. Chem. 354, 131 (1996)
18. Frank. H., Nicholson, G. J.. Bayer, E., J. Chromatogr. 167, 187 (1978)
19. Bichscl, V. E. et. al.. Requirements for the Quality Control of Chemically Synthesised Peptides and Biotechnically Produced Proteins. Pharm. Acta Helv. 71, 439 (1996)
20. Guidance for Industry for Submission of Chemistry, Manufacturing, and Controls Information for Synthetic Peptide Substances - Centre for Drag Evaluation and Research (CDER), November 1994
21. CPMP/QWP/130/96, Draft 3.4.1 1997. Note For Guidance on Chemistry of the New Active Substance
22. Braun, A. et al., Special Considerations Concerning Regulatory Requirements and Drug Development for Peptides and Biotech Products in the EU. Pfiarmaceutica Acta Helvetica 71, 447 (1996)
23. ICH Topic Q2A Note for Guidance on Validation of Analytical Procedures: Definitions and Terminology (111/5626/94)
24. ICH Topic Q2B Note for Guidance on Validation of Analytical Procedures: Methodology (CPMP/ICH/281/95)
25. ICH Topic Q3C Note for Guidance on Impurities: Residual Solvents (CPMP/1CH/283/95)
26. Starke. K., Grundlagen der Pharmakologie des Nervensystems in Allgemeine und spezielle Pharmakologie und Toxikologie.
27. W. Forth et al. (cds.). Spektrum Akademischer Verlag, Heidelberg (1996)
28. Römpp Chemie Lexikon, 9ih ed., Vol. 2 Cm-G. p. 1169, Georg Thieme Verlag, Stuttgart (1990)
29. Neumann, F. et ah. Endokrinpharmakologic Pharmakotherapie mit Hormonen in Allgemeine und spezielle Pharmakologie und Toxikologie. W. Forth et al. (eds.), Spektrum Akademischer Verlag, Heidelberg (1996)
30. Karek. U., GnRH und seine Analoga, Wissenschaftliche Verlagsgesellschaft mbH, Stuttgart (1996)