What is a degradation compound in drugs and how does it affect us?
Degradation compounds are substances produced by the breakdown of the active ingredient. Various impurities may result due to degradation of the active ingredient or some other interaction in storage, so stability studies need to be performed to ensure the safety of the product.
The presence of impurities in drugs makes it difficult, in many cases, to approve the registration of new pharmaceutical products, in addition to jeopardizing existing registrations, which has a negative economic impact on the activity of the affected companies.
At present, there are different methods to determine that these compounds do not present a risk to the safety and/or efficacy of pharmaceutical products. Therefore, these compounds would be qualified and can be marketed.
QSAR studies are a reliable alternative for the pharmaceutical industry to qualify degradation compounds and impurities according to the ICHQ3 A and B Guidelines.
At QSAR Analytics, our team of experts performs the study of these compounds to determine the safety of administration or exposure to the impurities.
QSAR studies are of great benefit to companies that have performed their impurity qualification through the following investigations:
- Evaluate the toxicological risk derived from the impurity.
- The cost of the resources and techniques employed is less than the cost, batch withdrawal or reformulation process.
- The report represents evidence before Health Authorities.
- Each of our reports includes full support before the corresponding authorities.