Table 1.

Storage conditions according to International Conference on Harmonization (ICH) pharma guidelines Q1A for the development of new drug products.

Study	Storage condition	Minimum time needed for data submission	Control points (months)
Refrigerated condition	5°C ± 3°C	12 months	0, 3, 6, 12
Long Term	Zone II 25°C ± 2°C 60% ± 5% RH Zone IVb 30°C ± 2°C/ 75% ± 5% RH	12 months	0, 3, 6, 12
Accelerated	40°C ± 2°C 75% ± 5% RH	12 months	0, 1, 2, 3, 6

RH: Relative Humidity.