Impurity Profiling & Screening Analysis
Oxford Analytical Services provides expert impurity profiling and screening analysis, ensuring your products meet regulatory standards, safety requirements and market expectations. Our GLP compliant testing supports biocides, agrochemicals, industrial chemicals, pharmaceuticals and technical materials, identifying and quantifying impurities to prevent compliance risks and ensure product integrity.
Using state-of-the-art analytical techniques, we detect even trace-level impurities, providing detailed impurity profiles that help you manage product quality, safety and regulatory submissions effectively.
Impurity Profiling Challenges We Solve
Understanding and controlling impurities is critical for product quality, regulatory compliance, and market approval. We help solve:
- Regulatory Compliance Risks: Ensuring compliance with BPR, REACH, PPP, ICH and other industry regulations
- Trace-Level Impurity Detection: Identifying unknown or unexpected contaminants at ultra low levels
- Stability & Degradation Monitoring: Analysing how impurities evolve over time to assess product stability
- Complex Formulation Challenges: Profiling multi-component products, detecting impurities, residual solvents and heavy metals
- Risk of Market Rejection: Providing scientifically robust data to support product approvals and prevent costly recalls
Our comprehensive impurity profiling and screening analysis ensures your product meets regulatory and safety standards with confidence.
Benefits and Unique Value of Oxford Analytical Services
Advanced Trace-Level Detection
Cutting-edge LC-MS/MS, GC-MS, ICP-MS and HPLC technologies for precise identification of even the smallest impurities.
GLP-Compliant Testing & Data Integrity
All analyses are conducted under Good Laboratory Practice (GLP) conditions, ensuring traceability, reproducibility and regulatory acceptance.
Customised Testing Strategies
Bespoke impurity profiling to meet the specific needs of your formulation and regulatory submission.
Fast & Reliable Turnaround Times
Rapid and accurate impurity screening, minimising delays in product development and registration.
Proven Track Record
Trusted by leading manufacturers, delivering high quality impurity analysis backed by case studies.
Regulations We Cover
Our impurity profiling and screening services ensure compliance with:
- Biocidal Products Regulation (BPR) – Regulation (EU) 528/2012
- Plant Protection Products Regulation (PPP) – Regulation (EC) No 1107/2009
- REACH – Registration, Evaluation, Authorisation and Restriction of Chemicals
- ICH Guidelines for Pharmaceutical Impurity Testing
- OECD Guidelines for Chemical Testing
Partner with Oxford Analytical Services
- Industry-Specific Expertise: Supporting biocide, agrochemical, industrial chemical and pharmaceutical manufacturers
- Advanced Analytical Techniques: Delivering highly sensitive impurity detection and profiling
- Customer Focused Approach: Offering customised testing solutions for your unique product challenges
Need impurity profiling and screening analysis?
Our services include:
Assesses product consistency across batches, ensuring compliance with regulatory standards. Determines technical equivalence by comparing composition, impurities and physical properties to reference materials. Learn more.
Provides expert guidance on analytical strategies, regulatory compliance, method selection and problem solving. Supports research, product development and troubleshooting for various industries. Learn more.
Determines the elemental composition of materials, detecting trace metals and other elements using techniques like ICP-MS and ICP-OES. Essential for regulatory testing and material characterisation. Learn more.
Identifies and quantifies impurities in raw materials, intermediates and final products. Ensures compliance with safety standards and supports formulation optimisation. Learn more.
Confirms the accuracy, reliability and reproducibility of analytical methods through independent verification, ensuring compliance with regulatory requirements. Learn more.
Diagnoses unknown contaminants, product failures, or unexpected variations using a range of analytical techniques. Supports root cause analysis and corrective actions. Learn more.
Designs and optimises robust analytical methods tailored to specific applications. Validates methods to ensure accuracy, precision, specificity and regulatory compliance. Learn more.
Evaluates key physical and chemical properties, such as solubility, stability, pH, viscosity and refractive index, supporting material characterisation and regulatory submissions. Learn more.
Characterises polymer composition, molecular weight, degradation and thermal properties. Supports material selection, quality control and failure investigations. Learn more.
Determines the chemical makeup of products, ensuring formulations meet regulatory and quality requirements. Useful for verifying ingredient levels and detecting contaminants. Learn more.
Provides regular testing to verify product consistency, purity and compliance with specifications. Supports manufacturing and regulatory compliance. Learn more.
Uses innovative and targeted approaches to detect unexpected compounds, emerging contaminants, or novel substances, supporting research and development. Learn more.
Evaluates product stability under various conditions to determine shelf life, degradation pathways and compliance with regulatory guidelines. Learn more.
Identifies unknown compounds using advanced spectroscopic and chromatographic techniques, ensuring proper classification, safety assessment and regulatory compliance. Learn more.