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EPP Ltd

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Penicuik, Midlothian, GB

About EPP Ltd

Your GLP Contract Research Organisation of Choice. EPP specialises in analytical, environmental sciences and research & development to help companies achieve product registration around the world.

EPP can provide support for REACH testing - we offer ecotoxicology, environmental fate and physico-chemical... Show more »

Your GLP Contract Research Organisation of Choice. EPP specialises in analytical, environmental sciences and research & development to help companies achieve product registration around the world.

EPP can provide support for REACH testing - we offer ecotoxicology, environmental fate and physico-chemical testing. We have the capacity and know-how to handle your studies with ease and efficiency.

We work within the agrochemical, human & animal pharmaceutical and industrial chemical sectors.

Why choose EPP

We are your GLP contract research organisation of choice combining value for money with superior quality of services, delivered by our experienced and technically expert scientists. We enlighten and empower our clients leading to smoother product registration.

We deliver this aim by providing integrated and specialist analytical and development services, of consistently superior quality, founded upon our expert competencies in screening and synthesis, analytical services including phys-chem and environmental sciences.

Our innovative approach and unequaled performance confirms our position as a trusted, reliable partner and the CRO of choice.

We are time and cost conscious and our practical tailored approach ensures we are well priced. Outcomes are important to everyone and developing long term partnerships with customers enables us to repeatedly deliver and bring cost effectiveness.

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Our Services (15)


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5-Batch Analysis

Price on request

At EPP, we are proud of our experience and capability to deliver a truly “one stop” service for GLP 5-batch analysis for pesticide registration. We follow a phased process, progressing to the next stage depending on the previous results obtained and provide a full GLP report summarising our findings for submission to the... Show more »

At EPP, we are proud of our experience and capability to deliver a truly “one stop” service for GLP 5-batch analysis for pesticide registration. We follow a phased process, progressing to the next stage depending on the previous results obtained and provide a full GLP report summarising our findings for submission to the appropriate regulatory body.

We have vast experience of hundreds of agrochemical active ingredients.

EPP has a great deal of experience tailoring your 5-batch analysis and report to the submission requirements dependent on regulations. You can be assured that client confidentiality is of the utmost importance to us and we have produced 5-batch reports for new products onto the market which have had the first submission in Europe and Brazil. International registration of pesticides also require physico-chemical testing which EPP are able to support.

For pesticide registration, 5-batch analysis is necessary for the following Regulatory Directives:

  • Brasil – ABNT NBR 14029: 2005, NBR 14029-2016
  • Europe – Regulation (EC) 1107/2009, referencing SANCO 3030/99 rev.4.
  • US – EPA Pesticide Assessment Guidelines OCSPP 830.1700 and 830.1800 in accordance with 40 CFR Part 158OPPTS
  • Argentina – SENASA requirements
  • Mexico – COFEPRIS requirements
  • Worldwide – FAO or IUPAC specifications on toxicological relevant impurities

5-Batch analysis – a step-wise process

Screening

This is one of our core strengths. Our unique blend of expert knowledge, experience and excellent instrumentation means we offer can easily screen your batches in a semi-quantitative process by GC (FID), HPLC (UV) and ion chromatography to determine those components above 0.06% w/w. At this early stage, our scientists can help you with your next steps.

Impurity identification and isolation

Our scientists then isolate and characterise the impurities found in technical materials. EPP has in house capabilities to isolate impurities from the technical material. We have GC-MS or LC-MS-MS to determine the specific nature of the impurities and if the compound is non-ionisable we have our own in-house NMR to aid with structural elucidation.

Custom synthesis of analytical reference standards

Most CROs will obtain reference standards from other labs, however EPP can help you save time and money by providing analytical reference standards from our own synthetic lab. All analytical reference standards are certified in house by using chromatographic purity. In addition, the standards can also be certified to GLP if required. There are certain compounds, particularly those containing phosphorous, such as glyphosate, fosetyl and ethephon which are difficult to certify by UV and therefore we can use qNMR to certify. Overall, our integrated labs help to prevent delays and we can ensure quality. We have experience of over 200 actives and we have many of these reference standards in stock.

Analytical method development

We can develop accurate, precise and specific methods of analysis for use in a variety of analytical applications including impurity assays and active assays. There may be cases whereby there is no CIPAC method is available or it is an older CIPAC method which is not fit for purpose any longer, EPP’s team of analysts can easily develop new robust chromatographic methods. In addition, methods can be transferred for sponsors’ in-house purposes or used at EPP in GLP regulatory studies.

Method validation

All methods developed are validated within SANCO 3030/99 rev.4 guidelines within the EU and all other requirements of the territory of submission.

Quantitative analysis of active and all components

Using HPLC (UV), GC (FID) and ion chromatography, the quantitative analysis of the active and all other components such as impurities and solvents are determined. EPP has invested in new software on our analytical instruments in order to comply with heightened data integrity requirements made by the MHRA.

Critical phase inspection

EPP has excellent in house QA staff who are extremely experienced. As part of strict adherence to GLP, a critical phase of the experimental work must be observed by QA, to ensure all laboratory results can be presented with confidence, quality and integrity.

Full GLP report

After all the experimental work is completed, a full GLP report detailing all aspects of the experimental work is produced in accordance with the area where submission is required.

Post-submission support

Even once the experimental and reporting is complete, we are able to assist you further with post-submission support.

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Physicochemical Testing

Price on request

EPP offers an extensive range of GLP physico-chemical testing in accordance with multiple guidelines including OECD, OJEC, and CIPAC across a variety of standards such as EEC Council Directives and the EPA.

Our team of highly experienced experts can help you to determine the most suitable set of tests to conduct and align the... Show more »

EPP offers an extensive range of GLP physico-chemical testing in accordance with multiple guidelines including OECD, OJEC, and CIPAC across a variety of standards such as EEC Council Directives and the EPA.

Our team of highly experienced experts can help you to determine the most suitable set of tests to conduct and align the work with other concurrent activities – for example 5 Batch Analysis – to reduce total project time.

The physico-chemical testing services we provide can address requirements for substance such as agrochemical technical grade active ingredients (TGAIs) and new regulations such as REACH.

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Ecotoxicity Testing

Price on request

EPP provides aquatic, terrestrial and marine ecotoxicology testing to evaluate the environmental safety of agrochemicals, biocides, human health products, animal health products and industrial chemicals in order to fulfill the requirements for registration. Major investment in our Environmental Centre has resulted in a fully GLP... Show more »

EPP provides aquatic, terrestrial and marine ecotoxicology testing to evaluate the environmental safety of agrochemicals, biocides, human health products, animal health products and industrial chemicals in order to fulfill the requirements for registration. Major investment in our Environmental Centre has resulted in a fully GLP compliant facility which is managed and operated by an experienced team of environmental scientists, who have worked for a number of large global companies.

Using a variety of guidelines and standards, including OECD, as the benchmark for all our environmental studies ensures that we can help you to achieve worldwide registration.

Our biologists draw upon the expertise of our analytical and synthetic chemists to provide a comprehensive service, with full analytical support, specialising in working with difficult substances including insoluble, unstable, volatile molecules and UVCBs.

At EPP we offer:

  • Aquatic ecotoxicology
  • Terrestrial ecotoxicology
  • Marine ecotoxicology

Ecotoxicology studies support our core sector expertise:

  • Registrations for Plant Protection Products and Biocides
  • Registrations for Animal Heath Products
  • Pharmaceuticals in the Environment
  • New Chemical Notifications & REACH
  • Offshore Chemicals Notifications Scheme (OCNS)
  • Toxicity-Based Discharge-Consents and Direct Toxicity Assessments (DTA)
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Environmental Fate Studies

Price on request

The established team of EPP environmental fate scientists have extensive experience gained from supporting global clients. We offer the full repertoire of studies across soils, sediments and natural waters, all conducted to GLP. EPP can support the testing of human and animal pharmaceuticals, agrochemical, biocides and industrial... Show more »

The established team of EPP environmental fate scientists have extensive experience gained from supporting global clients. We offer the full repertoire of studies across soils, sediments and natural waters, all conducted to GLP. EPP can support the testing of human and animal pharmaceuticals, agrochemical, biocides and industrial chemicals.

Operating from our purposefully designed facility, we have developed long term partnerships with our clients by being communicative and responsive to requests. Our environmental fate scientists are highly experienced and focus on delivering quality within realistic timelines. They specialise in working with new actives, which can be poorly soluble, unstable or UVCBs and also supporting registrations which require data gap fills.

At EPP, all studies can be undertaken using radio labelled substances such as 14C-labelled and 3H, as well as non-labelled. The environmental fate service is supported by a range of analytical capabilities such as LSC, radio-HPLC, HPLC-UV and LC-MS/MS.

Environmental Fate: Degradation and Accumulation Tests

OECD 301 Ready Biodegradability
OECD 305 Bioaccumulation in Fish: Aqueous and Dietary Exposure
OECD 307 Aerobic and Anaerobic Transformation in Soil
OECD 308 Aerobic and Anaerobic Transformation in Aquatic Sediment Systems
OECD 309 Aerobic Mineralisation in Surface Water – Simulation Biodegradation Test
OECD 315 Bioaccumulation in Sediment-dwelling Benthic Oligochaetes
OECD 316 Phototransformation of Chemicals in Water – Direct Photolysis
OECD 317 Bioaccumulation in Terrestrial Oligochaetes
OECD Draft Guideline Phototransformation of Chemicals on Soil Surfaces

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Chemical Synthesis

Price on request

EPP’s founder Dr. Stephen Newlands created the company on the basis of high quality synthetic organic chemistry. This founding feature remains true today and we have being providing custom synthesis of analytical reference standards for nearly 25 years. Our knowledge ranges across several sectors:

EPP’s founder Dr. Stephen Newlands created the company on the basis of high quality synthetic organic chemistry. This founding feature remains true today and we have being providing custom synthesis of analytical reference standards for nearly 25 years. Our knowledge ranges across several sectors:

  • Agrochemical reference standards
  • Pharmaceutical reference standards
  • Controlled drug reference standards

EPP’s synthetic lab supports our 5-batch analysis service, providing active and impurity standards, as well as degradants. This reduces delays in outsourcing. We also support other CROs and large manufacturing companies, providing high purity reference standards for use in their in-house QC testing.

Over 85% of our synthetic chemists have PhDs and we have a wealth of experience in difficult to synthesise compounds.

Our strengths lie in the custom synthesis of:

  • active reference standards
  • impurity reference standards
  • metabolite reference standards
  • degradation reference standards
  • We have experience of synthesising compounds related to over 200 actives, often those which are often closely related in terms of chemical structure.

All of our analytical reference standards are produced with a certificate of analysis typically including:

  1. PHYSICAL DATA
  • Appearance
  • Melting point
  • IDENTITY DATA
    • Proton NMR spectrum, 500MHz
    • Carbon NMR spectrum, 125.8MHz
    • FT-Infrared spectrum
    • LC-MS
  • PURITY DATA
  • HPLC-UV
  • Water content
  • Residual solvent by 1H NMR
  • Loss on drying
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NMR

Nuclear magnetic resonance spectroscopy
Price on request

EPP has it’s own in-house, GLP compliant, NMR facility supported by a dedicated and highly experienced NMR operator with many years’ experience in the field. As a result we can offer a stand alone NMR service to clients in addition to supporting our other EPP services.

Our NMR spectrometer is a Bruker Avance 500MHz running... Show more »

EPP has it’s own in-house, GLP compliant, NMR facility supported by a dedicated and highly experienced NMR operator with many years’ experience in the field. As a result we can offer a stand alone NMR service to clients in addition to supporting our other EPP services.

Our NMR spectrometer is a Bruker Avance 500MHz running Topspin and IconNMR. Samples can be run automatically with our 60 position sample changer. We can offer NMR experiments for 1H, 13C, 31P and other relevant nuclei (excluding 19F). We have experimental methods in place for 1D, 2D and Quantitative NMR. The instrument is fitted with variable temperature control, pulsed field gradients and shaped pulses.

We can identify compounds using 1D spectra from 1H, 13C and other nuclei, and various 2D experiments, including COSY, HSQC, NOESY and HMBC. Experiments using other 2D methods and other nuclei can be set up if required.

We can undertake quantitative NMR experiments to characterise materials and to certify standards examples being Ethephon, Glyphosate and Glufosinate.

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Imaging & Spectroscopy

Price on request

Imaging & Spectroscopy Services

Imaging & Spectroscopy Services

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Spectroscopy

Price on request

Spectroscopy Services

Spectroscopy Services

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Chemistry and Materials

Price on request

Chemistry and Materials Services

Chemistry and Materials Services

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Synthetic Chemistry

Price on request

Synthetic Chemistry Services

Synthetic Chemistry Services

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Agriscience

Price on request

Agriscience and Environmental Science Services

Agriscience and Environmental Science Services

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Agricultural Field Studies & Operations

Price on request

Field Studies & Operations Services

Field Studies & Operations Services

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Environmental Science

Price on request

Environmental Studies Services

Environmental Studies Services

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Analytical Chemistry Services

Price on request

Analytical Chemistry Services

Analytical Chemistry Services

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Agricultural Testing

Price on request

Agricultural Testing Services

Agricultural Testing Services

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Stephen Newlands

Managing Director

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