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.
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PHARMACEUTICAL ANALYSIS
RESOURCES:
Webinar: Characterization and Quantification by NMR
Webinar: Design of Extractables Leachables Studies
Article: Nitrosamine Impurity Screening in Drug Products
Article: Pharmaceutical Stability Contingency and Disaster Recovery
Webinar: E/L Studies for Process Materials and Container Closure Systems
Webinar: Identification and Quantification of Pharma Impurities
WHITE PAPER: Best Practice for Pharma Remote Audits
ARTICLE: Biomarker Development & Validation
WHITE PAPER: Strategic Partnerships with Contract Laboratory Organisations
WHITE PAPER: Mitigating Risks in Pharmaceutical Batch Release
WEBINAR: A Hi-Res Accurate Mass Spectrometry Validated Method for Nitrosamine Analysis
WEBINAR: Optimising Protein Impurity Analysis for AAV Capsids
REPORT:Peptide Therapeutics, Designing a Strategic QC Program
ARTICLE:Biophysical Characterisation of Biosimilars
WEBINAR: Glycosylation Site Specific Approaches for Antibody Therapies
WEBINAR: QC Strategy for Vaccine Development
eBOOK: Contingency Outsourcing Solutions
Access our comprehensive Digital Resource Library
Requirements for Elemental Impurities Testing
- White Paper download: Requirements for USP <232> and USP <233> elemental impurities testing. Download now
- Brochure download: Elemental Analysis, Elemental Impurity Analysis
- USP 233 and USP 232 Services
- ICH Q3D Risk Assessment and Testing
- Trace Metals Testing for Pharmaceuticals
- Pharmaceutical Impurity Testing
Pharmaceutical Impurity Analysis Service Update:
Detection and quantification of nitrosamine impurities (NDMA, NDEA, NMBA and NDIPA) using GC-MS and LC-MS methods. Learn more about this service.RECORDED WEBINARS
ACCESS NOW:
Design of Robust and Sensitive Extractables and Leachables Studies
Extractables and Leachables Applications: Studies on Process Materials and Container Closure Systems
Biocompatibility - The Importance of Extractables & Leachables Testing
Whitepapers:
White Paper Download Extractables and Leachables Strategies for Pharmaceutical Production Tubing
White Paper Download Extractables and Leachables Strategies for Transdermal Patch Products
White Paper Download Glass Delamination Studies for Pharmaceutical Vials
White Paper Download Trace Analytical Methods and Techniques for Testing Extractables and Leachables