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, quantification and analytical control strategies are key to optimizing purity, safety and control over the quality for either 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 or trace levels in highly complex sample matrices, and consequently, highly sensitive and specific analytical 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 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. For biologic therapeutics, we provide comprehensive services for the determination of bioprocess residuals or biopharmaceutical product-related impurities

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 & leachableselemental 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.

Inorganic impurities can result from the manufacturing process and typically include reagents, ligands and catalysts, heavy metals or other residual metals and inorganic salts. Our elemental impurity testing scientists and toxicologists help you to develop a testing and compliance strategy to achieve successful implementation of ICH Q3D requirements through tailored analytical programs and toxicological risk assessments.  Our laboratories utilise inductively coupled–optical emission spectroscopy (ICP-OES) and ICP–mass spectrometry (ICP-MS) to perform testing in accordance with USP General Chapter <232> and Chapter <233>, or suitable alternative procedures.

Our experts conduct laboratory studies to detect a wide range of organic impurities such as identified or unidentified, volatile or non-volatile, starting materials, by-products, intermediates, degradation products, reagents, ligands and catalysts. For new drug substances, we can help you to understand the actual and potential impurities which are most likely to arise during synthesis, purification, and storage. For new drug products, we can help you to assess the degradation products observed during manufacture and/or stability studies and impurities arising from the interaction with excipients and/or the immediate container closure system.

We provide expert determination and identification of residual solvents in pharmaceutical products, helping customers ensure that residual solvents have been reduced to acceptable levels  to ensure that the finished product will meet the limits specified in ICH Q3C(R5) or USP <467>/ Ph. Eur. 5.4, or the limit established by the drug product manufacturer for unique solvent(s).

Our experts have over 25 years’ experience in specialised analytical and toxicology assessment for extractables and leachables, and this is reinforced by our knowledge of polymer, plastic and packaging materials, allowing us to identify components from the most complex polymer formulations.

Our biopharmaceutical product characterisation team provide the determination of both product-related and process-related impurities in accordance with the ICH Q6B Guideline. Our scientists perform detailed studies using a wide range of analytical methods (e.g., HPLC, capillary electrophoresis, mass spectroscopy, NMR, FTIR, circular dichroism spectroscopies and size exclusion chromatography) to determine modified forms, altered conjugated forms, aggregates, cell substrate-derived process impurities, cell culture-derived impurities and downstream-derived impurities.

Related Links

Spotlight - Elemental

Requirements for Elemental Impurities 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.

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