The stability of drug products or substance is a significant parameter which may be affecting the safety, purity, and potency. The Forced degradation studies or stability indicating methods of chromatography are used for the analysis of stability of samples in different pharmaceutical manufacturing. These studies use to show the molecule chemical behavior which helps to develop formulation and packaging. Forced Degradation or stress study usually involves exposure of drug substances or product to humidity, heat, and light for solid-state studies, and also exposed to a different range of pH for solution-state studies the drug. This method is able to detect the loss of the analytes and consequently raise in degradation products. Preferably, loss in active component or product and raise in degradation products analyzed by an analytical method. The degradation study should achieve 10 to 30 % degradation of your analyte and all degradations should be properly separated by the column and from the analyte.
Various conditions for degradation are as follows.
- Hydrolytic Degradation
- Oxidative Degradation
- Thermal Degradation
- Photolytic Degradation
These are the studies of forced degradation that is used in the chromatographic analysis.
| You may also like this Hydrolytic Degradation Oxidative Degradation Thermal Degradation Photolytic Degradation Method Validation |
No comments:
Post a Comment