A critical assessment of the ICH guideline on photostability testing of new drug substances and products (Q1B): Recommendation for revision

Journal of Pharmaceutical Sciences

Volumn 99, Issue 7, 2010, Pages 2934-2940

  Baertschi, Steven W ^a   Alsante, Karen M ^b   Tønnesen, Hanne H ^c  

^a ELI LILLY AND COMPANY   (United States)

^b PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United States)

^c UNIVERSITY OF OSLO   (Norway)

Author keywords

Analytical chemistry; Chemical stability; Physical stability; Solid state stability; Stability

Indexed keywords

CALIBRATION; DRUG DESIGN; DRUG DISTRIBUTION; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG SCREENING; DRUG STABILITY; DRUG STORAGE; DRUG USE; NOTE; ULTRAVIOLET A RADIATION; ULTRAVIOLET B RADIATION;

EID: 77953302861     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22076     Document Type: Note

References (19)

1. ICH Q1B. 1997. Photostability testing of new drug substances and products. Fed Reg 62:27115-27122.
2. Tønnesen HH, Baertschi SW. 2004. The questions most frequently asked. In: Tønnesen HH, editor. Photostability of drugs and drug formulations. 2nd edition. Boca Raton: CRC Press. pp. 161-172.
3. Tønnesen HH. 2007. The International Conference on Harmanization Photostability Guideline. A discussion of experimental conditions. In: Piechocki JT, Thoma K, editors. Pharmaceutical photostability and stabilization technology, drugs and the pharmaceutical sciences, Vol. 163. New York: Informa Healthcare. pp. 47-60.
4. Tønnesen HH, Moore DE. 1993. Photochemical degradation of components in drug formulations. Pharm Technol Eur 5:27-33.
5. Templeton AC, Bowen WE. 2007. Unexpected photochemistry in pharmaceutical products: A review on the role of diluents, excipients, and product components in promoting pharmaceutical photochemistry. In: Piechocki JT, Thoma K, editors. Pharmaceutical photostability and stabilization technology, drugs and the pharmaceutical sciences, Vol. 163. New York: Informa Healthcare. pp. 223-252.
6. Piechocki JT. 2007. Sources. In: Piechocki JT, Thoma K, editors. Pharmaceutical photostability stabilization and technology. Drugs and the pharmaceutical sciences, Vol. 163. New York: Informa Healthcare. pp. 99-119.
7. Riehl J, Maupin C, Layloff T. 1995. On the choice of photolysis source for the photostability testing of pharmaceuticals. Pharm Forum 21:1654-1663.
8. Tønnesen HH, Brunsvik A, Løseth K, Bergh K, Gederaas OA. 2007. Photostability of ofloxacin in the solid state and in a tablet formulation. Photoreactivity of biologically active compounds. XVIII. Pharmazie 62:105-111.
9. Sue-Chu M, Kristensen S, Tønnesen HH. 2009. Photoinduced color changes in two different qualities of riboflavin in the solid state and in various tablet formulations. Photoreactivity of biologically active compounds.XX. Pharmazie 64:428-435.
10. Sue-Chu M, Kristensen S, Tønnesen HH. 2008. Influence of lag-time between light exposure and color evaluation of riboflavin in the solid state. Pharmazie 63:545-546.
11. Anderson N. 1997. A European perspective on photostability testing. Presented at Pharmaceutical Photostability, AAI Seminar Series, Arlington, VA, February 24-25.
12. Thatcher SR, Mansfield RK, Miller RB, Davis CW, Baertschi SW. 2001. Pharmaceutical photostability: A technical and practical interpretation of the ICH Guideline and its application to pharmaceutical stability: Part I. Pharm Technol US 25:98-110. (Pubitemid 33592106)
13. Tønnesen HH, Karlsen J. 1997. A comment on photostability testing according to the ICH guideline: Calibration of light sources. Pharmeuropa 9:735-736.
14. Brower JF, Drew HD, Juhl WE, Thornton LK. 1998. Quinine photochemistry: A proposed chemical actinometer to monitor UV-A exposure in photostability studies of pharmaceutical drug substances and drug products. Pharm Forum 24:6334-6346.
15. Kester TC, Zhan Z, Bergstrom DH. 1996. Quinine actinometry studies under two light sources specified by the ICH guideline on photostability testing. Seattle, Washington. Presented at the AAPS National Meeting.
16. Baertschi SW. 1997. Commentary on the quinine actinometry system described in the ICH draft guideline on photostability testing of new drug substances and products. Drug Stability 1:193-195.
17. Christensen KL, Christensen JO, Frokjaer S, Langball P, Hansen LL. 2000. Influence of temperature and storage time after light exposure on the quinine monohydrochloride chemical actinometric system. Eur J Pharm Sci 9:317-321.
18. Thatcher SR, Mansfield RK, Miller RB, Davis CW, Baertschi SW. 2001. Pharmaceutical photostability: A technical and practical interpretation of the ICH guideline and its application to pharmaceutical stability: Part II. Pharm Technol US 25:50-62. (Pubitemid 33638507)
19. Gauglitz G, Hubig SM. 2007. Chemical actinometry. In: Piechocki JT, Thoma K, editors. Pharmaceutical photostability and stabilization technology, drugs and the pharmaceutical sciences, Vol. 163. New York: Informa Healthcare. pp. 151-153.