A quality concept for impurities during drug development - Use of the hyphenated LC-MS technique

Pharmaceutical Science and Technology Today

Volumn 1, Issue 2, 1998, Pages 76-82

  Ermer, Joachim ^a   Kibat, Paul Gerhard ^a  

^a Hoechst Marion Roussel D   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG; SYNTHETIC PEPTIDE;

DECISION THEORY; DRUG IMPURITY; DRUG QUALITY; DRUG SCREENING; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; PRACTICE GUIDELINE; REVIEW; VALIDATION PROCESS;

EID: 0032077051     PISSN: 14615347     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1461-5347(98)00025-X     Document Type: Review

References (8)

1. 1 Ermer, J. and Möller, H. (1997) Regulatory Affairs J. 8, 722-729
2. 2 International Conference on the Harmonization of the Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q3A: Impurities in New Drug Substances (adopted March 1995)
3. 3 ICH, Q3B: Impurities in New Drug Products (adopted July 1997)
4. 4 ICH, Q3C: Impurities: Residual Solvents (Step 4, July 1997)
5. 5 ICH, Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
6. 6 Altria, K.D., Smith, N.W. and Turnbull, C.H. (1997) Chromatographia 46, 664-673
7. 7 Colon, L.A., Guo, Y. and Fermier, A. (1997) Anal. Chem. 69, 461A-467A
8. 8 Brückner, H. and Keller-Hoehl, C. (1990) Chromatographia 30, 621-629