In parallel with the process development, analytical development provides tools that are able to:
Monitor the process for side reactions
Monitor the process to reach required purity
Monitor the process to limit the residual impurities
Control the final API and ensure the required quality attributes
Minimize process and degradation impurities to afford formulators the maximum labeled drug shelf life under storage conditions
AmbioPharm will develop an analytical HPLC method specifically for separation of related substances and degradants from the main product, and deliver a method development report.
-Screen the analytical HPLC columns at various pH’s, ion-pairs, temperatures, buffer systems, and column packing materials to achieve separation of all the impurities from the main product
-Develop and optimize the analytical method to achieve the optimal separation of the related substances and degradants.-Perform forced degradation studies in acid, base, oxidant, heat and UV to further optimize the HPLC method by separating all of the degradants.
AmbioPharm will validate the developed HPLC method, and deliver a method validation report.
-AmbioPharm will write the analytical method validation protocol and will perform the analytical method validation.
-Intermediate Precision (=6)