Stability Studies

Shelf life can be assessed with a real time study where the product is tested at the initial stage and annually over the set shelf life of the product.

As this approach is time consuming and delays product market placement, customers can opt for accelerated study while undergoing real time testing.

Accelerated aging test involves isolating disinfectants as they are packaged into a humidity chamber with elevated test temperature. The temperature increased varies accordingly to the desired shelf life prediction.

According to the TGA guidelines, a minimum of four time points is required when undergoing accelerated aging test. Time recommended time points would be 0, 3, 6, and 9 months. The table below demonstrates the shelf life prediction within these time intervals.

The shelf life prediction with accelerated aging ranges from 1 to 3 years. Here are additional tips and points to note when an accelerated aging test has been considered:

• Products are to be monitored in a real time aging testing despite having done accelerated aging test. This is to ensure the shelf life predicted via accelerated aging test tallies and/or justifies the shelf life predicted via real time aging.
• Storage conditions of products generally ranges from 25oC to 30oC, elevated temperatures are added according to the shelf life intended to be predicted.
• The active concentration at the end of the accelerated aging test should not be below 90% of the initial active concentration claimed on the product label.