Services for Pharmaceutical products, Analytical Methods, Ecotoxicological studies, Environmental fate and behaviour studies #pharma #consultant


Posted On Apr 13 2017 by

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PHARMACEUTICAL PRODUCTS

A Medicinal product is defined as any substance or combination of substances presented for treating or preventing disease in human beings. Any substance or combination of substances which may be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings is likewise considered a medicinal product.

Medicinal products are regulated by the Directive 2001/83/EC. According to the implementation of this Directive the evaluation of the potential environmental risks posed by medicinal products should be submitted, their environmental impact should be assessed and, on a case-by-case basis, specific arrangements to limit the impact should be considered.

BioTecnologie B.T. Tests List

Physical, chemical and technical properties

  • Content of the Active Substance
  • Content of the Relevant Impurities

  • Fully Equipped Analytical Laboratory (HPLC DAD, GC/MS, LC MS/MS. etc.)
  • Method set-up and Validation
  • Residue analysis, Certificates of Analysis

Toxicity to Aquatic organisms

  • Daphnia magna Growth and Reproduction test (OECD 211 )
  • Growth Inhibition test on Freshwater Alga and Cyanobacteria (OECD 201)
  • Biodegradation – Activated Sludge Respiration Inhibition (OECD 209)

Toxicity to Terrestrial organisms

  • Soil Micro-organisms, Nitrogen Transformation test (OECD 216)
  • Earthworms, Acute Toxicity test (OECD 207)
  • Springtails, Collembolan Reproduction test in Soil (OECD 232)
  • Terrestrial Plant test, Seedling Emergence and Seedling Growth test (OECD 208)

Environmental fate and behaviour studies

  • Ready Biodegradability (OECD 301)
  • Adsorption-Desorption Using Batch Equilibrium Method (OECD 106)
  • Estimation of the Adsorption Coefficient on Soil and on Sewage Sludge Using HPLC (OECD 121)
  • Aerobic and Anaerobic Transformation in Aquatic Sediment System (OECD 308)
  • Aerobic and Anaerobic Transformation in Soil (OECD 307)

Last Updated on: April 13th, 2017 at 2:08 pm, by


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