MAIN SERVICES

RAW MATERIALS, NATURAL EXTRACTS, INTERMEDIATES AND FINISHED PRODUCTS 

PHYSICAL-CHEMICAL ANALYSES

 

  • ANALYTICAL METHOD DEVELOPMENT FOR HUMAN/VETERINARY
  • MEDICINAL, CHEMICAL, NATURAL AND NUTRACEUTICAL PRODUCTS
  • STABILITY INDICATING TRIALS OF CHROMATOGRAPHIC METHODS
  • VALIDATION OF ANALYTICAL METHODS ACCORDING TO ICH GUIDELINES
  • QUANTITATIVE AND QUALITATIVE DETERMINATION OF ACTIVE INGREDIENTS (API), RELATED SUBSTANCES, RESIDUAL SOLVENTS,CONTAMINANTS, PRESERVATIVES AND DYES
    (by chromatographic, spectroscopic)
  • PHYSICAL TESTING AND CHARACTERIZATION
    (by dissolution test, disintegration test, viscosity, density)
  • INHALER TESTING
    (by DUSA, USCA, ACI, NGI, MSLI and TSI apparatus for pressurized,dry powder inhalers and aerosol devices and by SPRAY VIEW® for the study of force/angle of delivery and shape/size of the particles delivered)
  • CLEANING VALIDATION
    (analytical procedure development and validation)
  • IDENTIFICATIONS
    (identification of impurities/degradation products)

STABILITY STUDIES

 

  • STABILITY STORAGE IN COMPLIANCE WITH ICH GUIDELINES
    (main available conditions: 5°C, 25°C/60%RH, 30°C/65%RH, 40°C/75%RH, for semipermeable and permeable containers, temperature cycling and photostability)

 

BIOANALYTICS

 

  • ANALYTICAL METHOD DEVELOPMENT
    (mainly by hplc-ms-ms)

  • METHOD VALIDATION
    (according to FDA/EMA guidelines)