Stability testing regulatory considerations

Regulatory considerations also play a part in a decision whether or not to use the direct compression process. Several years may elapse between the finalizing of a tablet formulation and its marketing. During this period, stability testing of the product will have occurred. The formulator must be confident that a chosen direct compression diluent will still be available for a considerable time after product marketing otherwise reformulation with all its attendant delay and expense will be required. A number of direct compression diluents have been marketed that were withdrawn after only a few years because of lack of market penetration. 

Smela M J (2005) Regulatory considerations for stability indicating analytical methods in drug substance and drug product testing. Am Pharm Rev 8 51-54. 

All antioxidants have points of strengths and weaknesses. Therefore, certain points, such as thermal stability, effective concentration, and synergism, should be taken into consideration when selecting antioxidants for use in particular foods. Regulatory status is another factor that cannot be ignored, especially for some antioxidants that have been reported to show potential adverse health effects. Synthetic antioxidants have been tested for safety and approval for use in food at low concentrations on the basis of complex toxicity studies (10). Allowable limits for use of antioxidants vary greatly from country to country, and depend on the food product under consideration (11). 

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