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  • Our services

    R&D services

    Development of a medicinal product,
    Design of research methods,
    Preformulation/deformulation, Stability studies

    Analytical studies

    Particle shape and size analysis,
    Chromatographic analyses,
    X-ray analyses,
    Release studies

    Technological tasks

    Mixing of dry forms,
    Mixing and homogenization of liquid and semi-solid forms,
    Granulation of powders,
    Manufacture of tablets

    GMP System

    Quality control testing of the finished product and starting materials 

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Strengths

Cannabis research

We perform quality control testing of cannabis plant and its extracts in accordance with the requirements of DAB 2020 Eingestellter and Good Manufacturing Practices (GMP):

The scope of work includes:

  • microscopic identification
  • determination of foreign matter content
  • density of extracts
  • water content of extracts using the KF method
  • identity of cannabinoids (TLC)
  • cannabinoid content and identity (HPLC)
  • solvent residue in extracts (HS-GC-FID)

Preformulation / Deformulation

We do preformulation and deformulation testing of medicinal products.

Our work includes

  • determining:
  • formulation ingredient distribution (CRM)
  • formulation manufacturing technology (CRM)
  • active substance’s polymorphic form (XRPD, DSC, CRM
  • testing:
  • release profiles (Apparatus I, II, IV, possibility of using biologically relevant media)
  • compatibility (contamination profile by chromatographic methods, DSC)
  • interaction of the medicinal product with water (wetting angle, disintegration mechanism, disintegration time)
  • solubility of the active substance (dissolution kinetics)
  • under stress conditions ( contamination profile by chromatographic methods, changes in polymorphic form and physical properties)
  • particle size and shape (optical microscopy, CRM, laser diffraction)
  • sorption and water activity (monitoring of physical, chemical and microbiological changes)
  • packaging (CRM)

We have a qualified and experienced team of specialists and equipment labs that allow for comprehensive testing of various forms of medicaments.

Analysis of the particle shape and size

We provide:

  • The analysis of breakdown of particle size and shape by microscopic imaging.

Instrument used:

Morphologi G3S (from Malvern Panalytical Ltd.).

  • it enables measurements in the 0.5 to 1000 µm range
  • due to the advanced capabilities of the software, the results can be presented in the form of a particle size distribution, in terms of their number or volume in relation to the whole tested sample
  • the software also enables a filtration of particles in terms of their size and shape according to the pre-defined preferences.
  • Analysis of the size distribution of solid particles, ranging from 0.01 to 3500 µm, by measuring the laser light diffraction scattered on the test sample.

Analyzers used:

Mastersizer 2000

  • equipped with Hydro 2000S wet dispersion accessory
  • Scirocco 2000 dry dispersion unit

Mastersizer 3000

  • equipped with Hydro MV wet dispersion accessory
  • Aero S dry dispersion unit
  • Analysis of the size distribution of droplets or atomized particles by using the laser diffraction in aerosols, sprays or inhalers.

Measurements are made with the analyzer

Spraytec

  • determination of droplet or atomized substance size in the 0.1 to 900 µm ranges.
  • The analysis of intranasal products is performed using an innovative automatic spraying system from SIPI.
  • Determination of the size distribution of nanoparticles by a dynamic light scattering (DLS) method with the use of an analyzer

Device used:

Zetasizer Nano ZS

  • extreme sensitivity of the device allows to measure very small particles, ranging from 0.6 nm to 6 µm
  • the DLS technique is used in measuring:
    • nanoparticles,
    • colloids,
    • proteins,
    • liposomes,
    • microemulsions
    • and many other substances
  • an additional advantage of our device is its ability to determine the Zeta potential.

We can provide the above measurements, tailored to individual needs of our clients, and where necessary develop analytical methods, their validations and deliver it all to the destination.

Head office

Centrum Badawczo-Rozwojowe “NOVASOME” Sp. z o.o.

Novasome R&D Centre


ul. Olsztyńska 5
51-423 Wrocław

tel. (+48) 71 325 62 42
e-mail: biuro@cbr.novasome.pl

Numer BDO: 000027336
REGON: 933042938
NIP: 8982061354
KRS: 0000225784

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