Table 1.

Conditions for accelerated stability testing and controls

Temperature (°C)	Relative humidity (%)	ICH/WHO* stability testing conditions
		For refrigerated products	For non-refrigerated products
5 ± 3	n. def.	Long term	–
25 ± 2	60 ± 5	Accelerated	Long term, zone II
30 ± 2	65 ± 5	Accelerated, more severe*	Long term*, zone IVa, intermediate
40 ± 2	75 ± 5	–	Accelerated

n. def. = not defined. According to the ICH/WHO,^22,28 long-term testing should cover the proposed shelf life or a minimum of 12 months at the time of submission. Stability testing under accelerated or intermediate conditions should cover a minimum of 6 months.

^*In addition to the conditions listed in the ICH guidelines, the WHO guidelines list also more severe conditions for products that are intended to be marketed in climatic zones III–IV. Malawi is assigned to climatic zone II and Rwanda to climatic zone IVa.²⁹