What should be the temperature and humidity settings of the stability chamber, while assessing the photostability of an orally used dosage form?

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Ruth Castillo

i recommend you the ICH HARMONISED TRIPARTITE GUIDELINE

STABILITY TESTING:PHOTOSTABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS Q1B. In my opinion, you should leave a stable temperature and humidity of the sample (normal) and just change the light. Thus keep some variables to modify the other. For climatic Zone IV (Colombia, my country) the normal condition is 30 ºC/65 % Hr.

Angkana Wichit

It depends on the product will be launch in a market and transportation. I recommend to read ICH HARMONISED GUIDELINE that is available on website.

Gaetano Ragno

The temperature must be maintained by a cool device