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Environmental Fate & Metabolism

SafePharm can now offer an entire suite of Environmental Fate and Metabolism studies, providing advice and studies to meet the requirements of REACH, EMEA, OECD, EPA, JMAFF or EU guidance.

With up-to-date facilities and industry-trained staff, we can offer a service based on experience, sound technical judgement and a proven track record of delivery to the customer.

In addition to standard “guideline” studies we can also offer a bespoke study service where the study design is developed in partnership with the client to ensure that the client’s needs are met. SafePharm have extensive experience of testing a very wide range of pharmaceuticals, crop protection products, chemicals, intermediates, impurities, and metabolites, and our staff have a demonstrated ability to deliver these complex and diverse study programs to time.

 


 

Safepharm can carry out all aspects of a study from the calculation of Predicted Environmental Concentrations (PEC’s), designing, completing and reporting the studies to modeling the end results and completing risk assessments.

Environmental Fate studies, usually using radiolabelled compounds, can be carried out in model systems, in the laboratory or in the field. As a crucial part of the Environmental Fate study, the characterization and identification of metabolites and degradation products (carried out in-house), provides key information about the test item and its potential for human and environmental risk.

In order to meet the various guideline requirements contained within current legislation, the following studies can be conducted at SafePharm :

Water

Laboratory
Aquatic Sediment (OECD308)

Aqueous (Natural Water and pH Buffered) photolysis

Independent Laboratory Validations

Radiolabelled and Non-Radiolabelled Hydrolysis Studies

Soil

Laboratory Soil Metabolism (Route)
(OECD307)

Outdoor metabolism field plots

Soil surface photolysis

Laboratory and Field soil degradation (Rate)

Crop

Primary Crop metabolism

Magnitude of the residue studies (crop and non-crop)

Crop Method Development

Confined Rotational Crop Studies

Air

Leaf and soil surface volatility

Residues in Air

Air Method Development

Independent Laboratory Validations

 

 

 

 
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