Successful Method Migration of USP Insulin Assay to the Alliance™ iS Bio HPLC System

Within the pharmaceutical industry, compendial LC methods are used to assess whether the regulatory specifications for finished products are met. Insulin, a polypeptide hormone consisting of two peptide chains, requires numerous liquid chromatography (LC) methods to accurately measure insulin, insulin degradation, and potency of insulin. This includes the USP Monograph for Insulin Assay, which measures the potency of the drug product.1 or method transfer or migration, the methods may be moved across systems with the goal of demonstrating equivalent performance.

In this work, the USP Monograph for Insulin Assay will be tested across multiple systems, evaluating both system suitability requirements and % API potency of the substance, USP Human Insulin RS. This work will demonstrate the key factors for successful method transfer of a regulated method across multiple systems.

Benefits
- The USP monograph for Insulin Assay method can be successfully migrated between multiple HPLC systems
- All suitability requirements for the USP monograph were successfully met across multiple systems which included USP resolution, USP tailing, and standard peak area %RSD
- Ability to successfully migrate the USP monograph for Insulin Assay to the Alliance iS Bio HPLC System and obtain better precision %RDSs in comparison to the other systems