Excellence as standard
At EPP you will enjoy superior quality, value for money services, delivered by expert and passionate people. We have a reputation for providing an excellent, comprehensive, one-stop service across the 5-Batch analysis spectrum. This one-stop shop service means we will be your one and only point of contact, there is no need to subcontract, saving time and administration costs. The close collaboration between our analytical and synthetic chemists means we are responsive, efficient and offer quick turnaround times. We provide clients with consistency across the analytical process.
Our analytical chemists, ranging from 4 to 40 years experience, collectively offer an expanse of knowledge blended with an understanding of contemporary chemistry. Our team has over 160 years combined analytical experience working on agrochemical and pharmaceutical chemical entities under GLP. This technical expertise, combined with our superb facilities and advanced equipment, sets us apart and enables us to expertly handle difficult substances. Underpinned with robust processes, we can support registration systems across the world and across different sectors.
Working with EPP, you can be assured we will deliver outcomes to complex projects. We can help achieve a smoother and faster registration for you.
The analytical and screening services we provide include:
- One stop shop for GLP 5-Batch analysis
- Impurity identification and isolation
- Analytical method development
- Re-certification and certification of analytical standards
- Structural elucidation
- Metabolite detection and identification
- Reference standards management service
- Independent counterfeit assessment service
- Literature searching
Smoother, faster registration
We understand your need for testing is regulatory driven. We provide support to the agrochemical, veterinary, pharmaceutical and industrial chemical sectors to help you achieve product registration.
We understand there are different regulatory processes across these different sectors. Our specialist knowledge and expertise enables us to handle complex projects, providing guidance and relevant advice to clients across all aspects of the registration process.
We can support registration systems across the world with our in-depth knowledge of registration processes in different countries around the globe.
How long do analytical and screening services take?
This depends on the type of analytical and screening work you need.
For example, a 5-Batch analysis study typically takes 2-3 months. If you are interested in any analytical and screening work please contact Bruce Craig to discuss your project in detail.
One stop shop for GLP 5-Batch analysis
At EPP we are proud of our experience and capability to deliver a truly “one stop” service for GLP 5-Batch analysis. We know this saves our clients time and money by eliminating the problems and delays associated with using multiple contract laboratories for different parts of the process.
We have been deemed GLP compliant by the MHRA since 2009 and can facilitate the entire screening, synthetic and reporting process required for GLP 5-Batch analysis. We follow a phased process, progressing to the next stage depending on the results obtained. We provide a full GLP report summarising our findings for submission to the appropriate regulatory body.
Impurity identification and isolation
This is one of our core strengths. Our unique blend of expert knowledge, experience and excellent instrumentation means we offer a superb prospect of identifying and isolating any impurity structure. Should the initial identification prove challenging, we can intensify the impurity and apply further techniques using in-house instruments such as GC-MS or LC-MS-MS to determine the specific nature of the chemical. We can then produce enough of the material to make a reference standard.
Analytical method development
We can develop robust, accurate and precise methods of analysis for use in a variety of analytical applications including impurity assays and active assays. These methods can be transferred for sponsors’ in-house purposes or used at EPP in GLP regulatory studies.
Re-certification and certification of analytical standards
Saving time and money at re-certification of analytical standards is important, particularly if the sample fails re-certification if it is impure. At EPP we can facilitate the rapid re-certification of analytical reference standards which have reached their expiry date. If the standards have maintained their integrity we can issue a new certificate of analysis, enabling our clients to continue their studies, GLP or otherwise, eliminating the need to reinvest in fresh, costly standards.
If the sample fails re-certification, we have the expertise to purify the material which can then be certified or resynthsise the material for certification.
The quality of your reference standard can make a dramatic difference to your project. If you are interested in high quality reference standards, you should consider our NMR certified reference standard service.
Essential for understanding the outcomes of synthetic reactions and the identification of impurities in technical materials, the structural elucidation of chemical entities plays a key part across our services. We have state-of-the-art instruments and facilities to ensure this process is as accurate and efficient as possible.
Metabolite detection and identification
Our metabolite detection and identification service supports pharmaceutical metabolic fate studies. Our facility is GLP compliant and we can screen for metabolites of non-radio-labelled and radio labelled compounds.
Using our Ion Trap Mass Spectrometers we can perform MSn experiments to maximise the structural information obtainable for a given molecule, particularly relevant for detecting unknown metabolites.
Reference standards management service
To save time and administration costs across the lifetime of a longer project, we can prepare larger quantities of reference standards at the start of the project and store these, supplying the exact quantity in the defined pack sizes as requested by the client.
The Categories of certified analytical reference standards that we provide include:
- standards for QC Testing Relating to Process Development and Routine Manufacture of Advanced Intermediates and APIs
- standards for API and Formulation Stability Testing Work
- standards for Pre-clinical Drug Development Work
Independent counterfeit assessment service
We offer an independent analytical service to support manufacturers in the identification of counterfeit products. We use LC-MS-MS / GC-MS / high field NMR analysis of suspected counterfeit “branded” generic products to determine authenticity.
We can undertake a full literature search for known synthetic routes, physical, spectroscopic, analytical and stability data associated with known fine chemical intermediates and pharmaceutical products, which include known and potential related impurities.
We compile a comprehensive technical report based on rigorous examination of abstract, primary, patent and secondary literature sources. This service can be extended to include known toxicology, pharmacology and environmental impact of specific target compounds, or classes of compounds, as part of a client’s hazard assessment or patent defence strategy.