STRESS STABILITY TESTING

1. BEST GUIDANCE AND PRACTICES FOR STRESS STABILITY TESTING RAHUL KUMAR YADAV PA/2010/08

2. AGENDA……….. 1) INTODUCTION 2) IMPORTANCE 3) EXPERIMENTAL DEGISNING 4) ISSUES 5) DIVERSITY IN INDUSTRYIAL APPROACH 6) CONCLUSION

4. what is our aim .

5. And what we needs.

6. And that is why industry adopt different testing procedures and thus difference in quality happen.HOW

8. Degradation pathways and degradation product.

9. Facilitate pharmaceutical development, packaging

10. Determination of intrinsic stability.

13. Have defined stress-testing groups, but less are in no that are centralized

16. Frequency of testing is different for drug product or substance

19. Limit : 5-20% degradation

22. RESOURCES PRIMARLY RESPONCIBLE FOR CONDUCTING STRESS TESTING STUDIES BY PHASE

24. Lc-uv or lc-diode is most accepted

25. Use of lc-nmr is only for special function

26. Lc-mass is for secondary use

28. APPROPIATE STAGE OF DEVELOPMENT

29. REPITATION OF TESTING

32. 1) more than 25 days

34. USE OF OXIDITAVIVE AGENT FOR OXIDATION

36. 2)temp.--------------------30°C

41. 2)temp.----------- >50°C

43. 2)duration---------7 days

48. Class II: Very labile

49. Class III: Labile

50. Class IV: Stable

51. Class V: Very stable

53. “ monographs”

54. 5-20% degradation of the active ingredients .

55. slightly excess of accelerated storage is recommended,.

56. major degraded product for ICH impurity threshold limit .