2.5.3. Photostability Study

The formulated injection was kept in Suntest Photostability Chamber (Model no. XLS+) providing an overall illumination of not less than 1.2 million lux hours and integrated near ultraviolet energy of not less than 200-watt hours/square meter in 3 packings for the duration of 10 days. This study was performed in three pack types with vials placed in inverted orientation. The primary pack of injection formulation was directly exposed to light by keeping the vials in USP type I clear glass vials (10 mL). For the secondary pack (market pack), the injection vials were enclosed in a carton and then placed in the photostability chamber. The control sample consisted of the primary pack covered with aluminium foil.