Analytical Development & Validation

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.

Method Development

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.

Screen the analytical HPLC or UPLC 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
Identify related substances in the API by LC-MS. Synthesize these peptides for spiking studies to identify and validate their relative retention times (RRT) by HPLC or UPLC.
Perform forced degradation studies in acid, base, oxidant, heat, and UV to further optimize the HPLC or UPLC method by separating all of the degradants.

Method Validation

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.

System Suitability
Accuracy/Recovery (n=3)
Precision (n=6)
Intermediate Precision (=6)
LOD (Limit of Detection)
LOQ (Limit of Quantification)
Linearity
Solution Stability
Specificity
Robustness