Our Services – Pharmaceuticals & Veterinary Medicine
Contamination and impurities
GMP and CMC Laboratory Services: Contamination and Impurities
Ensuring Purity, Safety, and Compliance in Every Dose
CEMAS offers comprehensive impurity and contamination testing services designed to detect, identify, quantify and evaluate the impurities in your Active Pharmaceutical Ingredients (APIs), raw materials and finished products in both the pharmaceutical and veterinary medicine industries.
Our team can support you with your impurity concerns, whether these are product contamination challenges, the presence of foreign materials in your product, manufacturing or process failures, raw material adulteration, or difficulties in product development. We have extensive experience in collaborating with clients identify impurities in new drug substances and new drug products, and we are adept at supporting your product development from an early stage and across the lifecycle of your drug product. We offer expert assistance in identifying and resolving these issues, suggesting solutions that address the root causes and help prevent future occurrences. Our services are designed to offer tailored strategies to get your production back on track and ensure the integrity, safety, and quality of your products, enabling you to meet regulatory standards and maintain consumer trust.
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Impurity Identification:
Contamination and Impurity Testing Services. We can identify and quantify impurities present in your products. Our profiling services include:
- Organic Impurities: Detection of process-related and degradation-related organic compounds Find out more here
- Inorganic and Elemental Impurities: Comprehensive testing for inorganic salts and trace elements using advanced techniques including IC and ICP-MS. Find out more here
- Foreign contaminant/particulate material identification: Complete testing service package to identify and help source the origin of visible particles in your product Find out more here
Method Development and Validation:
We develop and validate analytical methods to ensure accuracy and reliability in impurity quantification – Find out more
Stability Testing:
Our stability testing services monitor impurity levels over time, ensuring your product remains safe and effective throughout its shelf life – Find out more
Our Advanced Analytical Techniques
Our laboratories are equipped with the latest state-of-the art technology to provide accurate contamination and impurity assessments. Techniques we employ include:
- High-Performance Liquid Chromatography (HPLC)
- Ion Chromatography (IC)
- Gas Chromatography (GC)
- Mass Spectrometry (MS)
- Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
- Fourier Transform Infrared Spectroscopy (FTIR)
- Scanning Electron Microscopy (SEM)
- Energy Dispersive X-ray Spectroscopy (EDS)
Classification and example of Impurities
Information source: ICH Q3A(R2) and VICH GL10
Organic Impurities
Including:
- Starting materials
- By-products
- Intermediates
- Degradation products
- Reagents, ligands and catalysts
- Residual solvents
Inorganic Impurities
Including:
- Reagents, ligands and catalysts
- Heavy metals or other residual metals
- Inorganic salts
- Other materials (e.g. filter aids)
Why choose CEMAS?
Science
Our scientists and study directors bring decades of experience and expertise
Compliance
GLP, GCP and GMP compliance to ensure that your regulatory needs are met
Delivery
Flexibility and responsiveness to your requirements, to provide quality data on time
Reliability
Quality and delivery are at the heart of all we do
Further information
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Identification of Elemental Impurities
Our team can also assist in identifying the source of your elemental impurities. Understanding whether these impurities originate from raw materials, manufacturing processes, or packaging materials will enable you to take the appropriate corrective action to address the issue at its source and prevent recurrence.
Find out more about our:
Techniques: Inductively Coupled Plasma-Mass Spectroscopy (ICP-MS)
Identification of Organic Impurities
Our GxP compliant laboratories provide specialised organic impurity identification services designed to help you detect, identify, quantify and understand the organic impurities products. These include:
- Comprehensive Impurity Profiling:
- Advanced Analytical Techniques: Using state-of-the-art technologies such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), we provide accurate and thorough impurity profiling.
- Known and Unknown Impurities: We identify unknown impurities and contaminants or confirm the presence of known impurities, ensuring a complete understanding of your product’s impurity profile.
- Degradation Product Analysis: Our experts analyse degradation products that may form during manufacturing, storage, or use, helping you ensure product stability and safety.
- Regulatory Compliance Support:
- ICH and VICH Guidelines Compliance: We can validate the quantified impurity and ensure this complies with the latest guidelines, including ICH Q3A/B for pharmaceuticals and VICH GL10 for veterinary products, helping you meet global regulatory requirements.
- Detailed Reporting: We provide comprehensive reports that include all necessary data, analysis, and expert interpretation to support regulatory submissions and inspections.
- Root Cause Analysis:
- Source Identification: We can help identify the sources of impurities, whether they arise from raw materials, manufacturing processes, or packaging materials, allowing you to address issues at their origin.
- Process Optimisation: Our team will collaborate with you to investigate how impurities enter your products.
- Method Development and Validation:
- Custom Analytical Methods: We can develop and validate the required analytical methods tailored to quantify the relevant impurities.
- Robust Validation: Our validation processes ensure that your impurity analytical methods are robust, reproducible, and fully compliant with regulatory requirements.
Identification of insoluble matter and foreign particles
Particulate matter refers extraneous material, that arise from various sources and cannot always be easily quantified. It is typically classified as follows:
- Inherent: Particles that originate from the product itself, such as protein agglomerates.
- Intrinsic: Particles generated during the production process or from primary packaging materials.
- Extrinsic: Particles introduced from external sources, such as cellulosic fibres from cleaning tissue.
Foreign matter can present itself in any industry, on any product; whether this is a tablet, a pre-filled syringe, a medical device or even a food stuff. Foreign particulate matter testing in solution dosage forms is, furthermore, an essential component of the USP guidelines, aimed at ensuring that unintended and non-therapeutic particles do not exceed established limits. Particulate matter is generally categorised as visible (>100 μm) or subvisible (1–100 μm), with both classifications imperative in maintaining product quality, safety and efficacy.
CEMAS offers comprehensive, non-regulatory, visible foreign particle identification services in raw materials, intermediates and finished products; in all matrices. These are listed below, with the appropriate method tailored to the requirements of the study:
- Microscopic Examination
- Light Microscopy: Initial assessment and documentation of any foreign particles present.
- Electron Microscopy (SEM): High-resolution imaging to determine the size, shape, and morphology of the particulate matter.
- Chemical Analysis
- Energy Dispersive X-Ray Spectroscopy (EDS): Qualitative elemental analysis to identify the chemical composition of particles.
- Fourier Transform Infrared Spectroscopy (FTIR): Molecular spectroscopy to identify organic compounds present.
- Physical Characterisation
- Particle Size Analysis (Mastersizer): Determination of particle size distribution.
- Contaminant Source and Root Cause Analysis: Investigation of manufacturing processes to identify potential sources for contamination.
