Pharmaceutical Impurity Testing and Identification
GMP pharmaceutical impurity testing, analysis and identification to meet ICH Q3A and Q3B Guideline requirements and services for drug process impurities, residual solvents, genotoxic impurities, elemental impurities, contaminants or extractables/leachables
Pharmaceutical impurity testing, identification and quantification are vital to address the purity, safety and control over the 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 in 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. Current key examples are nitrosamine-related impurities such as NDMA that have been highlighted by the US FDA as a concern and are thought to be a result of the manufacturing process.
Our Pharmaceutical Impurity Analysis and Identification Testing Expertise
Our GMP compliant laboratories provide pharmaceutical impurity testing for new drug substances (ICH Q3A(R2)) and new drug products (ICH Q3B(R2)) that can support your product development from an early stage and across the lifecycle of your drug product.
Our scientists, who are adept at method development and validation of suitable analytical procedures, routinely overcome the challenges of low detection levels and difficult matrices, providing analysis expertise for resolving extractables and leachables, elemental impurities testing, residual solvents (OVI or VOC) analysis or (bio)process-related impurities.
Our experience extends across all dosage forms, product classes and drug delivery technologies, including inhaled drug product development. As part of our comprehensive stability study capability, we examine degradation products under stressed conditions to help establish degradation pathways and track/trend stability data. Additionally, we offer highly sensitive and specific method development and validation expertise to address the determination of, and control over, genotoxic impurities such as nitrosamines. The insight we bring from robust analytical studies can support your corrective and preventive action plans, accelerate your drug development program and simplify production impurity monitoring.
Impurity Toxicological Risk Assessments
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.
Total Quality Assurance
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.
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