Stability Indicating Methods – 6 relevant points necessary to consider.
1. API Stability-gathering data and information
API stability ought to be resolved in the beginning phases of formulation development. Appropriate usage will be helpful in gathering information and data on product stability which can lead to an optimized formulation.
2. Regulatory framework
Testing methodology must incorporate a stability indicating test which will distinguish the active ingredient from any degradation products and further able to make a believable estimate of the quantity of any degradation. All the information and data collected during these studies should be filed to regulatory agencies in timely manner and organization should be able to answer any queries raised by the concerned agencies repectively.
3. Degradation and Impurities study
Impurities are chemicals or solvents incorporated into a raw material during production. The level of impurities does not regularly change during study phase. Controlling the product process can minimize impurities and contaminations.
Degradates are obtained by principal compound breakdown. This in turn can lead to a drop in efficacy and may create unnecessary side effects from the finished product. Generally, as the level of ingredient decreases as degradates increase.
Identification tests, which are normally compendia techniques, are performed to gurantee the identity of an analyte in test sample.
Forced degradation is done to determine breakdown components of a finished product.
Main methods of forced degradation include: Accelerated-temperatures/ pH-extremes
Oxidation/Photolytic conditions.
Acidic/Basic Conditions.
4. Analytical Method Development
- When developing a stability testing method, be sure that the selected parameters are sufficient for the selected drug substance.
- Similarly the analyst should correspondingly cross verify the placebo-blank for interference from excipients.
- Sample preparation is a critical; analyst would take sufficient time to make sure the extraction step is efficient.
- During method development andoptimization the analyst should make sure the impurities and degradates will be detected.
5. Analytical Method Validation and Transfer (Chromatography)
- In validation, the specificity step confirms that the peak of interest is resolute from other peaks in the chromatogram, including degradates (Chromatography technique).
- The data or information obtained from forced degradation to identify degradates.
- During analytical method transfer from the analytical laboratory to the quality control laboratory, transfer itself must make the method as efficient as possible, if possible, without compromising separations.
6. Compendial Methods
- If stability indicating compendial method is not available, the analytical department should develop and optimize a method to detect degradent products before validation. (updated on 10.10.2020)