Review Article
Ophthalmic Drug Dosage Forms: Characterisation and Research Methods
Table 1
General conditions for stability examination [6].
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Relative 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. |