Photostability Analysis

Photodegradation can cause changes in the appearance of the drug and the chemical composition of the dosage form, resulting in the drug losing its therapeutic effect and possibly even forming toxic substances. Therefore, light stability research is a key part of the pharmaceutical process. ICH¹ presented in the 1996 industry guidance “the intrinsic photostability characteristics of new drug substances and products should be evaluated to demonstrate that, as appropriate, light exposure does not result in unacceptable change.” Photostability studies require forced degradation studies and confirmatory studies to ensure adequate detection and confirmation of pharmaceutical photodegradability.

Figure 1 Protocol for photostability studies of pharmaceutical products²

Alfa Chemistry's laboratories are equipped with a variety of light sources to meet the requirements of various testing scenarios. Alfa Chemistry's photostability testing helps you ensure pharmaceutical quality and meet FDA and ICH requirements. As a trusted partner, our experienced team of scientists dedicated to the pharmaceutical industry will always communicate with you for photostability testings while providing in-depth analysis of results to advise you on product quality, storage and transportation. For any photostability testing needs, please feel free to contact us.

The light sources Alfa Chemistry uses include but not limited to:

Alfa Chemistry has a wide range of equipments, such as:

Alfa Chemistry's Advantages:

References

• ICH Q1B. (1996) Guidance for Industry: Photostability testing of new drug substances and products.

• Welankiwar, Abhijjeet & Saudagar, Shrikant & kumar, Jitendra & barabde, Ashwini. (2013). “Photostability testing of pharmaceutical products.” International Research Journal of Pharmacy. 4. 10.7897/2230-8407.04904.