5-Batch Analysis and Technical Equivalence
Oxford Analytical Services specialises in 5-Batch Analysis and Technical Equivalence Studies, providing fast, reliable and GLP compliant testing solutions to meet the needs of industries like biocides, agrochemicals and industrial chemicals. Leveraging advanced analytical techniques, we deliver precise data to support regulatory submissions, product quality assurance and market readiness. With a tailored approach, we are a trusted partner for manufacturers navigating complex regulatory requirements.
5-Batch Analysis and Technical Equivalence Challenges We Solve
Clients in regulated industries often face significant challenges, including:
- Regulatory Compliance: Meeting the strict standards of BPR, REACH, and PPP regulations for product registration and ongoing approvals
- Complexity of Analysis: Ensuring active ingredients and impurities are identified and quantified with high accuracy
- Manufacturing Changes: Addressing the impact of manufacturing process modifications or new sourcing on product specifications
Time Constraints: Reducing delays in submission timelines for product registration or technical equivalence - Customised Requirements: Adapting testing protocols to align with unique product and regulatory demands
Oxford Analytical’s expertise and efficient processes ensure these challenges are resolved quickly and effectively, providing clients with peace of mind and actionable insights
Benefits and Unique Value of Oxford Analytical Services
Customised Testing Protocols
Tailored approaches for profiling active ingredients and significant impurities, adapting to the unique properties of each product.
Fast Turnaround Times
Comprehensive 5-Batch studies and Technical Equivalence analyses are completed within months, helping you meet tight regulatory deadlines.
GLP Compliance
Our laboratory adheres to GLP standards, ensuring data integrity and reliability for regulatory submissions.
Regulatory Expertise
Guidance on meeting BPR, REACH and PPP requirements, reducing the risk of non-compliance.
Advanced Analytical Techniques
State-of-the-art methods for impurity profiling, active ingredient quantification and method validation.
Extensive Experience
Proven track record with a wide range of actives, supported by detailed case studies and examples of successful testing outcomes.
Regulations We Cover
Our 5-Batch Analysis and Technical Equivalence services are designed to 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
What is 5-Batch Analysis?
5-Batch Analysis involves:
- Reviewing the Manufacturing Process: Assess information provided by the client
- Screening Representative Batches: Develop a material profile, including impurity profiling
- Method Development: Establish methods to identify at least 98% of the material
- Non-GLP Inspection: Confirm active ingredient percentages and significant impurities
- GLP Validation: Validate analytical methods for active ingredients and relevant impurities
- GLP 5-Batch Analysis: Conduct final analysis under GLP standards
This process ensures accuracy, reliability and compliance, all delivered within a competitive timeline.
What is Technical Equivalence?
Technical Equivalence Studies confirm that products with changes in manufacturing processes, sources, or manufacturers still meet their original specifications.
Steps include:
- Representative Batch Analysis: Follow similar steps as 5-Batch Analysis
- Comparison to Registered Specification: Ensure new specifications align with those already approved
- Additional Testing (if required): Conduct further analysis if specifications deviate from the registered standard
Partner with Oxford Analytical Services
With decades of experience, advanced equipment, and a commitment to fast, reliable results, Oxford Analytical Services is your trusted partner for 5-Batch Analysis and Technical Equivalence Studies.
Get a quote to discuss your specific requirements and timelines.
Let’s Get Started
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.