Ophthalmic Drug Dosage Forms: Characterisation and Research Methods

Table 1

General conditions for stability examination [6].

Study	Storage conditions	Minimum time period covered by data at submission
Long term*	25°C ± 2°C/60% RH^1 ± 5% RH; or; 30°C ± 2°C/65% RH ± 5% RH	12 months
Intermediate**	30°C ± 2°C/65% RH ± 5% RH	6 months
Accelerated	40°C ± 2°C/75% RH ± 5% RH	6 months

1Relative humidity.
∗It is up to the applicant to decide whether long-term stability studies are performed at 25 ± 2°C/60% RH ± 5% RH or 30°C ± 2°C/65% RH ± 5% RH.
∗∗If 30°C ± 2°C/65% RH ± 5% RH is the long-term condition, there is no intermediate condition.