Product-related Impurity Analysis

Product-related impurities are molecular variations that differ from the target drug ingredient in terms of activity, efficacy, and safety. These impurities are essential for evaluating the product’s safety and efficacy. To isolate sufficient quantities, typically on the milligram scale, for characterization and method validation of quality control procedures, skilled researchers use various technologies such as MALDI-MS, LC-MSMS, HPLC, IR, NMR, and fluorescence.

Peptide truncations are created through chemical or enzymatic cleavage, and their fragments are characterized via chromatography (e.g., HPLC) or SDS-PAGE. Peptide mapping is an additional mass spectrometry service offered to learn more about the variation. Other modified forms, such as deamidated, isomerized, mismatched S-S-linked, oxidized, or altered conjugated forms, are determined using various chromatographic, electrophoretic, and/or other analytical methods.

In a laboratory setting, the AktaTM Fast Protein Liquid Chromatography (FPLC) technology is used for semi-preparative scale ion-exchange chromatography purification of acidic and basic species. In-house quality control checks are conducted using SDS-PAGE, A280, IEF, and ion exchange chromatography. The Agilent 1200TM system can be used for purifying aggregates and structural variants of the product via scaled-up size exclusion chromatography.

Infinita’s GLP/GMP compliant protein analysis laboratories offer an extensive array of isolation techniques and characterization technologies, ensuring that drug substances and products conform to all regulatory expectations and specifications. Through Total Quality Assurance services, they can help achieve quality, safety, and regulatory goals.

Video 01: Effective Workflow for Pharmaceutical Impurity Analysis using HR- LCMS