ANALYTICAL STUDIES

The ANALYTICAL STUDIES Unit of ChemService has been acting in compliance with GLP (Good Laboratory Practices) since  1994 and supplies analytical studies conducted in accordance with internationally acknowledged methods (i.e. OECD, CIPAC, Regolamento (EC) No 440/2008).

In compliance with the principle of mutual acknowledgment of data (MAD), BPL analytical studies in accordance with OECD guidelines supplied by ChemService are acknowledged and accepted in Europe, North America (USA), South America (i.e. Brazil, Argentina), Asia (i.e. India, China, Malaysia, Thailand), Australia, Africa (i.e. South Africa).

NOTE: GLP  studies conducted in compliance with internationally accepted guidelines (OECD CIPAC, etc.) are needed to obtain the authorization to use and market technical and formulated  preparations (plant protection products, biocides, chemicals, cosmetics and veterinary products) by European authorities (European Member States, EFSA, ECHA, EMEA, etc.), as well as extra-European autorities (US EPA, US FDA, ANVISA in  Brazil,  SENASA in Argentina, CIBRC in India, etc.).

AVAILABLE StudiES AND ANALYSES

5-Batch Analyses

  • Screening of the active ingredient content and impurities.
  • Validation of analythical methods for active ingredients and impurities.
  • Analysis of the content of the active ingredient and impurities in the 5 batches.
  • Synthesis and/or separation (with preparative columns) of impurities (relevant, significant).
  • 5-Batch spectroscopic analysis (UV, IR, MS, NMR).

Determination of chemical and physical parameters (CIPAC, OECD, OPPTS methods, Regulation EC N. 440/2008)

  • Chemical and physical characterization of substances and formulated products (OECD, CIPAC methods, Regulation EC N. 440/2008).
  • Spectroscopic characterization of chemical products (UV, VIS, IR, NMR, MS 3D analysis).

Accelerated and long-term stability (OECD, GIFAP)

Bacterial and Fungicidal efficacy tests on detergents

Studies on susbstances' behaviours into water, soil, air and bioaccumulation studies (OECD 106, OECD 107, OECD 111, OECD 112)

Studies on residues

  • Development and validation of mono and multi-residue analytical methods in vegetal matrices, water, soil and muds, animal tissue, milk and dairy products, oils and air. (SANCO 3029/2004).
  • Application of the validated methods to analysis of residues in various matrices (i.e.vegetables, fruits, milk, water, soil, air) from efficacy tests.

Development and Validation of analytical methods

  • Implementation and validation of analytical methods for the identification and quantification of active ingredients in technical and formulated products.
  • Implementation and validation of analytical methods for the identification and quantification of significant and relevant impurities in the active ingredients.
  • Implementation and validation of analytical methods for the determination of active ingredients and their metabolites in biological fluids and tissues homogenated.

REGISTRATION SUPPORT

Protocols and documentation for registration Dossiers and notification for PPP, biocides, new and existing chemicals.

TRAINING

Ad hoc training courses about implementation and validation of analytical methods to identify and quantify active ingredients and impurities in technical and formulated products.