Global Comparison of Stability Testing Parameters and Testing Methods for Finished Herbal Products

Table 4

Storage conditions used for accelerated stability testing.

Global community	Testing period (container type)	Storage condition (temperature/relative humidity, RH)
		In ambient storage	In refrigerator	In freezer
ASEAN [1]	0, 3, and 6 months (including the initial and final time points)	40°C ± 2°C/75% RH ± 5% RH	25°C ± 2°C/60% RH ± 5% RH	—
EEC [7]	6 months (general container)	40°C ± 2°C/75% RH ± 5% RH	25°C ± 2°C/60% RH ± 5% RH or 30°C ± 2°C/65% RH ± 5% RH or 30°C ± 2°C/75% RH ± 5% RH	—
	6 months (semipermeable container)	40°C ± 2°C/not more than 25% RH	—	—
EMA [35]	6 months (general container)	40°C ± 2°C/75% RH ± 5% RH	25°C ± 2°C/60% RH ± 5% RH	—
	6 months (semipermeable container)	40°C ± 2°C/not more than 25% RH	—	—
ICH [36]	6 months (general container)	40°C ± 2°C/75% RH ± 5% RH	25°C ± 2°C/60% RH ± 5% RH	—
	6 months (semipermeable container)	40°C ± 2°C/not more than 25% RH	—
WHO [3]	6 months (general case)	40°C ± 2°C/75% RH ± 5% RH	25°C ± 2°C/60% RH ± 5% RH or 30°C ± 2°C/65% RH ± 5% RH or 30°C ± 2°C/75% RH ± 5% RH	—
	6 months (semipermeable case)	40°C ± 2°C/not more than 25% RH	—	—
Australia [12]	6 months (general container)	40°C ± 2°C/75% RH ± 5% RH	25°C ± 2°C/60% RH ± 5% RH	—
	6 months (semipermeable container)	40°C ± 2°C/not more than 25% RH	—
Brazil [37]	6 months (impermeable container)	40°C ± 2°C	25°C ± 2°C	−20°C ± 5°C
	6 months (semipermeable container)	40°C ± 2°C/75% RH ± 5% RH	25°C ± 2°C/60% RH ± 5% RH	−20°C ± 5°C
China [17, 18]	0, 1, 2, 3, and 6 months (general container)	40°C ± 2°C/75% RH ± 5% RH	25°C ± 2°C/60% RH ± 5% RH	—
	0, 1, 2, 3, and 6 months (semipermeable container^a)	40°C ± 2°C/20% RH ± 5% RH	—	—
	0, 1, 2, 3, and 6 months^b	30°C ± 2°C/65% RH ± 5% RH	—	—
Hong Kong [21]	Every month for 3 consecutive months	37°C–40°C/75% RH ± 5% RH	—	—
Japan [24]	6 months (general container)	40°C ± 2°C/75% RH ± 5% RH	25°C ± 2°C/60% RH ± 5% RH	—
	6 months (semipermeable container)	40°C ± 2°C/not more than 25% RH	—	—
Korea [27]	More than 6 months (general container)	40°C ± 2°C/75% RH ± 5% RH	25°C ± 2°C/60% RH ± 5% RH	—
	More than 6 months (semipermeable container)	40°C ± 2°C/not more than 25% RH	—	—
Philippines [28, 29]	—	40°C ± 2°C/75% RH ± 5% RH	—	—
Zambia [34]	0, 1, 2, 3, and 6 months	40°C ± 2°C/75% RH	—	—

^aIncludes multilayer coextrusion polyvinyl chloride soft bag injection and plastic bottle containing ophthalmic solution or nasal solution. ^bIncludes plasters, colloids, ointments, gels, ophthalmic ointments, suppositories, and aerosols.