Method development is the process of proving that an analytical method is acceptable for use in our laboratory to measure the concentration of an API in a specific compounded dosage form. Full method development procedures are complex, extended, and expensive endeavors. These studies usually are required when data from the analysis is going to be submitted to regulatory authorities for certification of a new or amended drug application. The analytical method is tested extensively for specificity, linearity, accuracy, precision, range, detection limit, quantitation limit, and robustness. For...
Method development is the process of proving that an analytical method is acceptable for use in our laboratory to measure the concentration of an API ...