Stability Indicating Method Development
USP <621> <797> <1225>
To validate the analytical method utilized to assess the pharmaceutical article. CIAL has the ability to develop and validate a stability indicating method (also referred to as a stability indicating assay) for single and multiple component formulations. This process includes deliberately degrading the formulation with acid, base, peroxide, light and heat to generate all possible break-down substances that could potentially occur during the stability study. A method will then be developed and tested with these degraded samples to be certain the breakdown products would not interfere. Once the method(s) have been developed, it will be validated according to USP <1225>, which includes accuracy, specificity, linearity, precision, system suitability, and ruggedness.
Stability Indicating Method DevelopmentStability Indicating Methods
Price depends on complexity of formulation
To assess the pharmaceutical component using a stability indicating method, that has been proven to be accurate and reliable, as per USP <1225>. A stability indicating method must first be developed and validated on the specific pharmaceutical article in order for the stability study to be considered stability indicating.
Requires Stability Indicating Method Development