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Stability Indicating Methods – 6 relevant points necessary to consider.

1. API Stability

API stability should be determined in the early stages of formulation development. Proper utilization will be helpful in gathering information on product stability and leading to an optimized formulation.

2. Regulatory framework

Testing procedures must include a stability indicating test which will distinguish the active ingredient from any degradation products and be able to make a reliable estimate of the quantity of any degradate.

3. Degradation and Impurities study

Impurities are chemicals or solvents incorporated into a raw material during production. The level of impurities does not typically change over time. Controlling the product process can minimize impurities.

Degradates are formed by component breakdown. They can cause a drop in efficacy or create side effects from the finished product. Typically, the level of ingredient decreases as degradates increase; this is the difference between degradates and impurities.

Identification tests, which are usually compendial method, are performed to ensure the identity of an analyte in a sample and reflect the purity characteristics.

Forced degradation is done to determine breakdown products of a material. 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 conditions are adequate for the API. You should check the placebo blank for interference from excipients.

Sample preparation is a critical; you should take the time to ensure the extraction step is sufficient. If you are optimizing or modifying the method, ensure that impurities and degradates will be detected.

5. Analytical Method Validation and Transfer In validation, the specificity step verifies that the peak of interest is separated from other peaks in the chromatogram, including degradates. You should use forced degradation to identify degradates. If you are transferring the method from the analytical laboratory to the quality control laboratory, you must make the method as efficient as possible, if possible, without compromising separations.

6. Compendial Methods

Knowing your compound’s impurity profile and checking for degradates will ensure that your method will remain compliant. If stability indicating compendial method is unavailable, you can develop and modify a method to detect breakdown products before validation.





