Shedding Light On Photostability Forced Degradation

Forced degradation testing is essential for understanding the degradation pathways of drug substances and products, going beyond accelerated testing to simulate more extreme conditions. This process helps in product and packaging development, ensuring stability under various stressful conditions. A subset of forced degradation is photo-stability testing, which evaluates a drug's response to light exposure, as outlined by the ICH and FDA guidelines. These guidelines recommend a systematic approach, including tests on the drug substance, drug product in its packaging, and the marketing pack. Different light sources, including fluorescent and near UV lamps, are specified for these studies, with careful temperature control to minimize variation. The guidelines distinguish between testing procedures for drug substances and drug products, providing valuable insight into photo-stability testing practices.

SK pharmteco Analytical Services offers comprehensive photo-stability studies, supported by advanced equipment such as high-resolution and triple-quadrupole mass spectrometers, to identify potential degradants and ensure product stability. Learn more about how we can support your photo-stability testing needs by reading the full article below.