Highly Sensitive single LC-MS/MS Method for Cleaning Validation of Synthetic Peptides Using Shimadzu LCMS-8060

User Benefits

- Six synthetic peptides quantified using a single LC-MS/MS method with LLOQ of 0.5 ng/mL - Customized analytical method for peptides of different therapeutic categories - Non-specific binding and low sensitivity issues addressed to make the method compatible for biological sample analysis

Introduction

As per supplementary guidelines on good manufacturing practices by WHO - “Cleaning validation is required as documented evidence to establish that cleaning procedures are removing residues to predetermined levels of acceptability, taking into consideration factors such as batch size, dosing, toxicology and equipment size”. The objectives of good manufacturing practices (GMP) include the prevention of possible contamination and cross-contamination of pharmaceutical starting materials and products. Pharmaceutical products can be contaminated by a variety of substances such as contaminants associated with microbes, previous products (both active pharmaceutical ingredients (API) and excipient residues), residues of cleaning agents, airborne materials, such as dust and particulate matter, lubricants and ancillary material, such as disinfectants, and decomposition residues from: A rapid, simple, sensitive, single method for, • Product residue breakdown occasioned by, e.g. the use of strong acids and alkalis during the cleaning process; and • Break down products of the detergents, acids and alkalis that may be used as part of the cleaning process. Adequate cleaning procedures play an important role in preventing contamination and cross-contamination. Validation of cleaning methods provides documented evidence that an approved cleaning procedure will provide clean equipment, suitable for its intended use. The analytical methods required for cleaning validation of active pharmaceutical ingredients require a different approach for development of different drug substances. In case of critical pharmaceutical products like peptides, these methods has to address the challenges posed by peptides viz poor ionisation, non-specific adsorption and carry-over. Shimadzu Application Development Centre (ADC) has developed a highly sensitive LC-MS/MS method for quantitation of six synthetic peptides i.e., abaloparatide, glucagon, cosyntropin, semaglutide, ganirelix acetate and liraglutide. The developed method is applicable to detect an LLOQ of 0.50 ng/mL for all 6 analytes and can be utilized for conducting the cleaning validation studies.

January 22, 2024 GMT