Photo Stability Chamber
Photostability Studies are prescribed by ICH (International Society for Harmonization) and these guidelines specify that the drug & the drug product must be photo tested to ensure that exposure to light does not cause photochemical degradation of the product & the packaging.
Photostability studies of drugs and drug products are an integral part of the product development process in the pharmaceutical industry. These studies are carried out to ensure quality, efficacy, and safety of the formulated products during manufacture, storage, and use.
In view of the photosensitivity and photo instability of drugs and adjuvants, knowledge of the photostability of these substances and their formulated products is necessary to evaluate the following:
- The intrinsic photostability characteristics.
- The physical and chemical changes upon the exposure to light.
Photostability chambers are specifically designed to perform near UV and visual light testing with fluorescent lamps per ICH Q1B Guidelines,
Allyone offers two choices for your photostability chambers:
- Photostability Chamber (with Lux & UV Light testing) &
- Photostability Chamber (with Temperature & RH Control)
The study as per the guideline is performed to should identify precautionary measures needed in manufacturing or in formulation of the product, and if light resistant packaging is needed.
The samples are tested both pre & post photostability studies, i.e. exposure for any changes in appearance, clarity, or colour (physical properties) & for degradation (chemical).