Setting specifications

LCGC North America

Volumn 22, Issue 6, 2004, Pages 536-542

  Swartz, Michael ^a   Krull, Ira ^b  

^a WATERS CORPORATION   (United States)

^b NORTHEASTERN UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 33749582527     PISSN: 15275949     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (13)

1. "ICH Q6A: Specifications for New Drug Substances and Products: Chemical Substances," International Conference on Harmonization of Technical Requirements for the Registration of Drugs For Human Use, Geneva, Switzerland, March 1995 (see also www.ICH.org under topic of Quality guidelines).
2. Federal Register 65(251), 83,041-83,063 (December 29, 2000) (see also www.fda.gov/cder/guidance/index.htm under the topic of ICH Quality Guidelines).
3. "ICH Q2A: Text on Validation of Analytical Procedures." International Conference on Harmonization of Technical Requirements for the Registration of Drugs For Human Use, Geneva, Switzerland, March 1995.
4. "ICH Q2B: Validation of Analytical Procedures: Methodology," International Conference on Harmonization of Technical Requirements for the Registration of Drugs For Human Use, Geneva, Switzerland, May 1997.
5. The United States Pharmacopeia 25/National Formulary 20, 2256-2259 (2002).
6. Federal Register 68(68), 6924-0925 (February 11, 2003).
7. Federal Register 68(220), 64,628-64,629 (November 14, 2003).
8. Federal Register 68(219), 64,352-64,353 (November 13, 2003).
9. J.D. Orr, I.S. Krull, and M.E. Swartz, LCGC 21(7), 626 (2003).
10. J.D. Orr, I.S. Krull, and M.E. Swartz, LCGC 21(12), 1146 (2003).
11. Chirality 4, 338-340 (1992).
12. The United States Pharmacopeia 25/National Formulary 20, 2082-2084 (2002).
13. Federal Register 68(225), 65,717-65,718 (November 21, 2003).