At the same time as the peptide development process is underway, AmbioPharm develops analytical HPLC (High Performance Liquid Chromatography) and UPLC (Ultra Performance Liquid Chromatography) methods and validation tools.
These tools monitor the process for side reactions, required purity standards, and limit any residual related substances in the product. By controlling the final API to ensure the required quality attributes, we will minimize process and degradation products. This affords formulators the maximum labeled drug shelf life under proper storage conditions.
AmbioPharm will develop an analytical HPLC or UPLC method specifically for separation of related substances and degradants from the main product and deliver a method development report.
AmbioPharm will validate the developed HPLC or UPLC method, write the analytical method validation protocol, and perform the analytical method validation. We will deliver a method validation report.