PREFORMULATION Ning（预制剂宁）.ppt

Study Storage condition Minimum time period covered by data at submission Long term 25°C ± 2°C / 60% ± 5% r.h or 30°C ± 2°C / 65% ± 5% r.h. 12 months Intermediate 30°C ± 2°C / 65% ± 5% r.h. 6 months Accelerated 40°C ± 2°C / 75% ± 5% r.h. 6 months Drug substances - General case Drug substances - intended for storage in a Refrigerator Study Storage condition Minimum time period covered by data at submission Long term 5°C ± 3°C 12 months Accelerated 25°C ± 2°C / 60% ± 5% r.h. 6 months 04/05/2012 KLE College of Pharmacy, Nipani. * Drug substances/Product- intended for storage in Freezer Study Storage condition Minimum time period covered by data at submission Long term -20°C ± 5°C 12 months Drug products - General case Study Storage condition Minimum time period covered by data at submission Long term 25°C ± 2°C / 60% ± 5% r.h. or 30°C ± 2°C / 65% ± 5% r.h. 12 months Intermediate 30°C ± 2°C / 65% ± 5% r.h. 6 months Accelerated 40°C ± 2°C / 75% ± 5% r.h. 6 months 04/05/2012 KLE College of Pharmacy, Nipani. * Drug products - packaged in Semi-permeable containers Study Storage condition Minimum time period covered by data at submission Long term 25°C ± 2°C / 40% ± 5% r.h. or 30°C ± 2°C / 35% ± 5% r.h. 12 months Intermediate 30°C ± 2°C / 65% ± 5% r.h. 6 months Accelerated 30°C ± 2°C / 65% ± 5% r.h. 6 months Drug products - intended for storage in a Refrigerator Study Storage condition Minimum time period covered by data at submission Long term 5°C ± 3°C 12 months Accelerated 25°C ± 2°C / 60% ± 5% r.h. 6 months 04/05/2012 KLE College of Pharmacy, Nipani. * . From the graph no : time period to have 90% potency for each temperature namely 37°c, 45°c and 60°c were ascertained for Formulation F3 which are depicted in the following table Temperature under study Time required to have a 90% potency (days) i.e.‘t’ 90% 37°C 262 45°C 192 60°C 95 CALCULATIONS FOR SHELF LIFE PREDICTION ‘t’ 90% values from the above table then convert into log ‘t’ 90% and th