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
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:
We offer precise and GLP-compliant Substance Identification (Substance ID) Analysis tailored to the unique needs of industries such as biocides, agrochemicals and industrial chemicals. Find out more here.
We have been developing tailored methods at affordable prices for many years. Our chemists have developed thousands of methods over the years from simple single actives to complex products covering a wide range of levels and product types.
We can also validate already developed methods or support you through your own method development journey via consultation.
Our validation expertise covers global requirements including SANCO/3030/99, SANTE/2020/12830 and ICH Q2, OPPTS 830.1800 and APVMA among others. Find out more here
Need data for registration or a safety data sheet?
From explosive properties through to partition co-efficient, we cover a wider range of physical tests and can also develop our own in-house methods for novel experiments.
We use a range of methods from CIPAC, ASTM, ISO, OPPTS, OECD and more to meet global regulatory requirements. Find out more here
We can carry out impurity profiling, product screening, method validation and 5 batch analysis or Technical Equivalence studies to meet your registration needs. Our team develop tailored methods for your products and can also support with structural identification requirements.
We have many years of experience with successful studies over many compounds from Citric Acid to Pyrethrins covering elemental impurities, isomers, and additives of all types.
Whether your product is a TC, or TK we can help. Find out more here
We can design storage stability studies with or without GLP accreditation under the Biocides, Plant Protection, or ICH guidelines to support registration around the world. Find out more here
New regulations around Biocides came into place in 2012 . We have since therefore worked with industry to support registration needs conducting 5 batch analysis, routine testing, storage stability, physical testing and more on a wide range of Biocides.
Biostimulants are a wonderful new way to protect our plants and wildlife by using nature to protect itself. They are natural substances harnessed for their characteristics. After that they are developed into products that can be applied to seeds, plants and soils in order to stimulate natural growth.
We have worked with consultants and direct customers for many years supporting their Agrochemical registration testing requirements under global regulations. Find out more here
The fertiliser market is well established but under scrutiny with the introduction of new regulations demanding more rigorous testing and reducing acceptable levels of elements.
We are one of few labs that can offer the full suite of Fertiliser testing including Inorganic Arsenic, and Chromium VI. Find out more here
Need a reasoned case for a regulator? Trying to develop a product or a method? See what our chemists and consultants can do to help. Find out more here
We can cover elemental to extremely low levels. For instance if you just need to identify, quantify, or fully validate a method. Our ICP systems cover a wide range of elements often working on 10+ elements at the same time.
We regularly work on Silver, Lead, Arsenic, Chromium, Cadmium, Mercury, Copper, Boron and Sodium to name a few. Our list of capabilities stretches much longer! Find out more here
Need routine quality checks, one offs or concerned about contamination?
New regulations to meet? We often take on complex novel projects and it is what we are known for! Our chemists enjoy doing something different! Find out more here
Whether you are carrying out the development of a new formulation, changing suppliers or adjusting existing products, we can support you with formulation development and experimentation through product composition and formulation GLP compliant testing. Find out more here.