Study Set Content:
It is also not expected for every listed test to be performed
every time
Real time Products
NCE, Generics, and Variations (MaV and MiV)
Accelerated
NCE, Generics, and Variations (MaV and MiV)
alternatives to accelerated study
Generics, and Variations (MaV and MiV)
Real-Time testing frequency
0,3,6,9,12,18,24 months and annually through the proposed shelf-life
Accelerated
0,3 and 6 months
alternatives to accelerated study
0,1, and 3 months
30oC ± 2 oC/75% RH ± 5% RH
Long term (for products in primary containers semi-permeable to water vapour)
30oC ± 2 oC /RH not specified
Long term (for products in primary containers impermeable to water vapour)
40oC ± 2 oC/75% RH ± 5% RH
Accelerated
40oC ± 2 oC/75% RH ± 5% RH or at more stressful conditions
Stress testing
is necessary for analytical method validation, pharmaceutical formulation, identifying and monitoring potential degradants during stability testing.
Stress testing
Dynamic viscosity units
Pa*s, Poise, P
Kinematic viscosity units
m2/s Stokes, St.
Tablets
Hardness test
Hard gelatin capsules
Brittleness
Soft gelatin capsules
Pellicle formation
Emulsion
Phase separation
non-metered topical aerosols
Spray pattern
