Pharmaceutical Impurity Testing
GMP pharmaceutical impurity testing to meet ICH Q3A and Q3B Guideline requirements for process impurities, elemental impurities or extractables/leachables
Pharmaceutical impurity testing and quantification is vital to address the purity, safety and quality of drug substances or finished drug products. Pharmaceutical impurities can arise from many sources and include starting materials and their contaminants, reagents, catalysts, solvents, intermediates, excipients and their contaminants, leachables and degradation products. They can be organic impurities, both process and drug-related, inorganic or elemental impurities. These impurities are often present at very low levels highly complex sample matrices, and consequently, sensitive and specific assay methods are required to determine the levels of the impurity to collect the data required to complete relevant risk assessments or to support submission requirements. A recent example is NDMA-related impurities potentially found in ranitidine or some angiotensin II receptor blocker (ARB) medicines that have been highlighted by the US FDA as a concern and are thought to be a result of the manufacturing process.
Our GMP compliant laboratories provide pharmaceutical impurity testing for new drug substances (ICH Q3A(R2)) and new drug products (ICH Q3B(R2)) which can support your product development from an early stage and across the lifecycle of your drug product.
With scientists who are adept at method development and validation of suitable analytical procedures, we can overcome the challenges of low detection levels and difficult matrices. As part of our comprehensive stability study capability, we examine degradation products under stressed conditions to help establish degradation pathways. Additionally, we offer highly sensitive and specific method development and validation expertise which is required to address the issues of genotoxic impurities.
With many years of experience in toxicological risk assessments, our consultants conduct risk assessments to address the issues associated with exposure to residual solvents, process impurities, extractables & leachables, elemental impurities (ICH Q3D) and other substances that may find their way into a pharmaceutical product.
Pharmaceutical impurity testing is one aspect of our global GMP and CMC laboratory services solutions which include pharmaceutical analysis, stability testing, quality control (QC) and batch release testing. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards.
Need help or have a question?