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GLP studies for product registration

Physical-chemical Properties

Our laboratories can carry out in complete autonomy the analyses required for the chemical-physical characterization of technical products and formulations established by the Regulatory Authorities.

The analysis are performed both on conventional products and on natural extracts used as low-risk agropharmaceuticals. We have also developed an important experience on hybrid formulations.

IDENTIFICATION OF THE ACTIVE INGREDIENT AND 5-BATCH ANALYSIS

  • analytical profile of the lots
  • content of active ingredients and certificate of analysis
  • identification, characterization and quantification of relevant and significant impurities

The recent purchase of the latest generation of preparative HPLC has allowed us to internalize and speed up the separation of impurities necessary for 5-batch analysis.

PHISICAL-CHEMICAL CHARACTERIZATION OF TECHNICAL PRODUCTS

  • UV-VIS, FT-IR, MS, HRMS absorption spectra
  • solubility in water and solubility in organic solvents
  • dissociation constant in water
  • octanol / water partition coefficient
  • melting point / melting range, boiling point
  • steam pressure and volatility

PHYSICAL PROPERTIES OF DANGER

  • flammability and self-flammability
  • explosive properties test (shock test, friction, Koenen thermal sensitivity)
  • oxidizing properties test

CHARACTERIZATION OF PHYSICAL-CHEMICAL FORMULATED

  • appearance
  • pH and acidity / alkalinity
  • apparent and relative density
  • particle size distribution, suspensibility, dissolution constant
  • physico-chemical compatibility with other products
  • hydrolysis

STABILITY STUDIES

  • accelerated stability (different times and temperatures)
  • Shelf Life at different temperatures

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