Forced degradation of pharmaceuticals

American Pharmaceutical Review

Volumn 7, Issue 3, 2004, Pages 56-61

  Reynolds, Dan W ^a  

^a GLAXOSMITHKLINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

ARTICLE; AUTOMATION; COMPUTER PROGRAM; DRUG FORMULATION; DRUG INDUSTRY; DRUG ISOLATION; DRUG OXIDATION; DRUG SOLUBILITY; DRUG SOLUTION; DRUG STABILITY; DRUG STORAGE; DRUG SYNTHESIS; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; PROCESS OPTIMIZATION; REACTION ANALYSIS; SOLID STATE; STEREOCHEMISTRY; STORAGE TEMPERATURE;

EID: 3042826837     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (15)

1. Reynolds, Dan W.; Facchine, Kevin L.; Mullaney, June F.; Alsante, Karen M.; Hatajik, Todd D.; Motto, Michael G. Available Guidance and Best Practices for Conducting Forced Degradation Studies Pharmaceutical Technology, February 2002, 48-56.
2. ICH Q1A(R) Stability Testing of New Drug Substances and Products, Revision 1 (August 2001).
3. ICH Q1B Photostability Testing of New Drug Substances and Products (November 1996).
4. Guidance for Industry: INDs for Phase 2 and 3 Studies; Chemistry, Manufacturing, and Controls Information (Issued May 2003).
5. Submitting Documentation for the Stability of Human Drugs and Biologics (CDER, Issued 2/1987)].
6. Q3A(R) Impurities in New Drug Substances (FDA: February 2003) and Q3B(R) Impurities in New Drug Products (FDA: July 2000).
7. Q3A(R) Impurities in New Drug Substances (CDER: February 2003).
8. FDA, Q6A International Conference on Harmonization; Guidance on Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (December 2000).
9. Byrn, Stephen J.; Pfeiffer, Ralph R.; Stowell, Joseph G. Solid State Chemistry of Drugs (Second Edition, SSCI, Inc., 1999), 307.
10. Baertschi, Steven W.; Alsante, Karen M.; Martin, Linda A Stress Testing Benchmarking Study Pharmaceutical Technology, FEBRUARY 2003, 60-72.
11. Stability Testing of Drug Substances and Drug Products (DRAFT Guidance, Issued 6/1998, Combination of Q1A-Q1C and Q5C)(2); Conners, Kenneth A.; Amidon, Gordon L.; Stella, Valentino J. Chemical Stability of Pharmaceuticals (2nd Ed, Wiley, 1986), p. 19.
12. Dean, John A. Handbook of Organic Chemistry (McGraw-Hill, Inc., 1987), section 9-3.
13. For example, esters hydrolyze rapidly in base. For this reason, most compounds containing esters should be stressed at a pH no greater than 8 for basic hydrolytic studies.
14. Reactions with singlet oxygen generated photochemically or thermally are examples of oxidation which may not be facilitated by peroxides.
15. Sims, Jonathan L.; Roberts, John K.; Bateman, Adrian G.; Carreira, Judith A.; Hardy, Martin J. An Automated Workstation for Forced Degradation of Active Pharmaceutical Ingredients Journal of Pharmaceutical Sciences, 2002, 91(3), 884-892.