Influence factors test is conducted under drastic conditions, its purpose is to understand the factors affecting drug stability and possible degradation pathways and degradation products, to provide a basis for the prescription, process, packaging, storage conditions, transportation, use and expiration date / retest period determination of the preparation.
Some drug structures contain groups prone to degradation, which may be subject to hydrolysis, light, oxidation and other degradation, resulting in impurities.
The influence of the package material on the stability of the drug is also very important. A good package material can not only facilitate the use of patients and improve compliance, but also prolong the storage time of the drug and reduce the miscellaneous quality.
The chemical structure, impurities, physical state, water content, particle size, surface area, particle morphology, and the ratio of main drug to excipients of excipients can all have an impact on stability.
The structure of light-sensitive drugs generally contains phenolic hydroxyl groups, double bonds, etc. Light can cause changes in the color of the drug and an increase in impurities.
Oxidation reactions generally include the autoxidation of free radicals. Oxidative degradation is strongly influenced by light, metal ions, solutions or solids. Phenolic drugs are susceptible to oxidation, mostly because the phenolic hydroxyl group becomes quinone-like structure and appears yellowish brown, etc.
An increase in temperature generally increases the rate of degradation and accelerates the change in physical properties of the drug, which needs to be controlled at different temperatures.
The main moisture sensitive groups are amide bond, ester bond, etc.
Polymerization can make two or more molecules dehydrated and polymerized to produce large molecules, polymerization will make the drug discolored and impurities increase.
The drug may appear new isomers in the process of stability, and the type of isomerization can be divided into optical isomerization and geometric isomerization.
Chemical changes may occur during the various stages of formulation production.
CD Formulation provides you with analysis of drug stability influencing factors to help you efficiently evaluate factors that may lead to loss of stability during drug development, thus avoiding instability of the drug due to extraneous factors. We develop a comprehensive stability impact factor design program for you and can conduct multiple stability study experiments, and then evaluate the potential factors.
Evaluation of the stability of the drug by testing its properties (color, melting point, etc.), composition content, water of crystallization, etc.
We can provide our clients with sample testing solutions (including test methods, test conditions, and testing instruments) to help them improve the stability of their drugs during drug development.
If you have a requirement about our services, please contact us by phone or email, our colleagues will reply to you within three working days.