ICH Photostability testing

ICH photostability testing is used in the pharmaceutical, cosmetic, and food industries to evaluate the stability and effectiveness of products when exposed to light. It is important to ensure that products can withstand light exposure and maintain their potency and efficacy over time. Testing is done on a single batch of material and may need to be repeated if modifications are made to the product. The testing methodology includes tests on the drug substance, product, and packaging. Specific exposure criteria must be met for pharmaceuticals, and the testing is also used in the cosmetic and food industries for evaluating additives and colourants.

ICH PHOTOSTABILITY TESTING

ICH photostability testing is a process used to evaluate the ability of pharmaceutical and cosmetic products to maintain their stability and effectiveness when exposed to light. This testing is important in the pharmaceutical and cosmetic industries to ensure that products can withstand exposure to light and maintain their potency and efficacy over time. 

Testing is done on a single batch of material that has been chosen. If specific modifications and alterations are made to the product, these tests may need to be repeated (e.g. formulation, packaging). Depending on the photostability parameters established at the time of first filing and the type of variation and/or change made, investigations may need to be redone.

It is advised to use a methodical testing methodology that takes into account, wherever necessary, research like:

• Tests on the drug’s substances
• Tests on the drug product that was exposed that aren’t part of the immediate pack, and if necessary
• If necessary, tests the drug product in the immediate box.
• Testing on the product in the marketing package

According to Q1B criteria, pharmaceuticals must be exposed to 200 W h/m2 of UVA radiation and 1.2 million lux hours of visible light. These examinations are also known as Confirmatory Studies.

Here are some specific industrial use cases for ICH photostability testing: 

• In the pharmaceutical industry, ICH photostability testing is used to assess the photostability of drug substances and products.
• In the cosmetic industry, ICH photostability testing is used to assess the photostability of cosmetic ingredients and finished products.
• In the food industry, ICH photostability testing is used to evaluate the photostability of food additives and colourants.

Video 01: Quality Assurance-ICH Photostability testing