CEM Analytical Services

CEMAS carries out GLP-compliant physico-chemical, storage stability, and method validation studies and provides the full range of analytical data in support of the registration of Plant Protection Products within the European Union as outlined in Annex III of Directive 91/414/EEC.

In addition, we are able to satisfy the data requirements for United States EPA registration (as stated in the Series 830.6000 and 830.7000 OPPTS Assessment Guideline) and for Australian AVPMA registration.

The Agrochemical Products Unit has recently expanded its laboratories and studies are carried out with state-of-the-art testing equipment and a wide range of environmentally controlled cabinets where temperature and/or humidity can be regulated and monitored.

The services available include:

• Physico-chemical Testing
  
• Storage Stability
  
• Method Validation
  
• Biocides Analysis
  
• Formulation Development
  
• Photostability Testing
  
• Batch Release
  
• Method Development or Modification
  
• GLP Compliance
  

Equipment Available:

• Analytical instrumentation including HPLC (with UV, DAD, fluorescence, MS and MS/MS) and GC (with FID, ECD, FPD, NPD and MS).
  
• IC with conductivity detection.
  
• A wide range of physical testing equipment.
  
• A full range of environmentally temperature and/or humidity controlled cabinets for the conduct of accelerated and long-term storage stability studies. All environmentally controlled storage facilities are subject to continuous monitoring.
  
• Photostability cabinets.
  

CEMAS has over 10 years of experience of conducting agrochemical product studies. CEMAS staff members are highly motivated individuals with significant experience in conducting a range of studies to internationally recognised testing guidelines while our Study Directors are dedicated to developing and maintaining relationships with clients throughout the life of projects to ensure delivery of quality data on time.

CEMAS provides a comprehensive bioanalytical service for samples collected during pre-clinical and clinical trials. We offer full method development and validation and have the capacity to carry out large-scale sample analysis.

Services Offered:

• Measurement of drug concentrations in biological fluids and tissues for pre-clinical and clinical trials.
  
• Dried Blood Spot (DBS) analysis.
  
• Receive and analyse samples from clinical trials worldwide.
  
• Storage of samples at -20°C and -80°C
  
• Continuous computer monitoring of all storage locations.
  
• Method Development.
  
• Method Validation.
  
• Method Transfer.
  
• Data formatted to meet customers reporting needs.
  

Equipment Available:

• HPLC (UV/Vis, DAD, EC, RI, fluorescence).
  
• LC-MS/MS – four SCIEX API 4000, one with a QTRAP, three with Spark-Holland SymbosisTM Pharma, one Sciex API 5000 plus four SCIEX API 5500.
  
• Chromatographic data acquisition, processing and retention through Agilent ChemstationTM, Agilent ChemstoreTM, and PE Sciex AnalystTM (LC-MS/MS) software.

CEMAS carries out physico-chemical, storage stability, and method validation studies and provides formulation data to client-specified needs. The Formulation Development Unit has recently expanded its laboratories and studies are carried out with state-of-the-art equipment and a wide range of environmentally controlled cabinets where temperature and/or humidity can be regulated and monitored.

The services available include :

• Physico-chemical Testing
  
• Storage Stability
  
• Method Validation
  
• Photostability Testing
  
• Method Development or Modification
  

Equipment Available:

• Analytical instrumentation including HPLC (with UV, DAD, fluorescence, MS and MS/MS) and GC (with FID, ECD, FPD, NPD and MS).
  
• IC with conductivity detection.
  
• A wide range of physical testing equipment.
  
• Formulation development equipment for a range of formulation types.
  
• A full range of environmentally temperature and/or humidity controlled cabinets for the conduct of accelerated and long-term storage stability studies. All environmentally controlled storage facilities are subject to continuous monitoring.
  
• Photostability cabinets.
  

Members of staff at CEMAS have many years of experience of conducting formulation studies and are highly motivated.

The Section can offer a range of analytical techniques and methods to characterise soils, sediments, water and plant tissue to support GLP Studies and other projects. Soils, sediments and waters are tested using established physical and chemical classical methods using a range of analytical techniques.

Analyses available include:

For Waters and Solutions

• pH
  
• Total suspended solids
  
• Silt content
  
• Total organic carbon and Dissolved organic carbon
  
• Nitrate, nitrite and ammonia
  
• Total hardness – EDTA titration
  
• Carbonate, bicarbonate, water hardness quality assessment
  
• Electrical conductivity

The Section can offer a range of analytical techniques and methods to characterise soils, sediments, water and plant tissue to support GLP Studies and other projects. Soils, sediments and waters are tested using established physical and chemical classical methods using a range of analytical techniques.

Analyses available include:

For Soils and Sediments

• Organic Carbon/Organic Matter: Walkley Black titration method
  
• Organic Carbon/Organic Matter: Loss on Ignition method
  
• pH in water and other salts
  
• Cation Exchange Capacity – Sodium saturation
  
• Particle Size Distribution fractionation/sedimentation: Pipette method
  
• Water Holding Capacity, maximum and field capacity: Hanging water table
  
• Water Holding Capacity at field capacities and wilt point: Ceramic pressure plate
  
• Microbial biomass (Substrate Induced Respiration, Anderson and Domsch)
  
• Mineral Nitrogen: nitrate, nitrite, ammonium and ureic nitrogen

Environmental & Geological Sciences Services

Under the new EU system of Registration, Evaluation, Authorisation and Restriction of Chemicals (REACh), enterprises that manufacture or import more than one tonne of a chemical substance per year are required to register it with the new European Chemicals Agency. Each registration submission consists of a Technical Dossier and, for substances above 10 tonnes, a Chemical Safety Report (CSR). Failure to register will mean that the substance cannot be manufactured or imported. The REACh legislation means that approximately 30,000 existing substances will need to be registered by 2018.

CEMAS can help meet the regulatory requirements of the REACh programme, offering a wide range of tests, conducted to EU standardised testing methods in accordance with Good Laboratory Practice (GLP), and providing information to aid preparation and submission of the required technical dossier.

CEMAS analytical services

CEMAS can carry out all necessary analytical studies to meet the requirements of REACh including:

• Physical-Chemical Testing. All required tests for all the tonnage categories.
  
• Methods of Detection and Analysis, including Method Development and Validation
  
• Storage Stability Studies
  

CEMAS sees continual investment in state-of-the-art instrumentation as crucial to our success. Spark-HollandTM Pharma technology has been acquired to complement our LC/MS/MS (Sciex API 4000 and 5000) systems. CEMAS has both ambient and environmentally controlled storage for accelerated and long-term storage stability studies.

Study design, protocol and reporting are tailored to satisfy regulatory requirements using both CEMAS standard procedures and specific customer requirements.

Regulatory Affairs Services

Project Management & Consulting Services

Agriscience Services

Agricultural Toxicity Tests Services

Food Analytical Testing Services

The Residue Analysis Section analyses crop, soil, water and veterinary residues to generate data to support agrochemical and veterinary registrations in accordance with GLP. The diverse and versatile workforce has experience with a wide variety of pesticides and the capability to manage Studies from initiation to submission thereby offering a complete Study Management service to deliver reports tailored to client specific needs. The Section has expertise in generating data to regulatory guidelines including Regulation (EC) No. 1107/2009, SANCO/825/00 rev.8-1 (2010) and OPPTS 860.1340.

Product Development & Testing Services

Field Studies & Operations Services

Agricultural Product Testing Services

Pharmacology & Toxicology Services

Formulation & Manufacturing Services

Product Quality Control Services

Analytical Chemistry Services

Chemistry and Materials Services