We offer analytical services in the development, validation and transfer of analytical methods and testing of starting materials and final products according to pharmacopoeial monographs. We use specialised analytical equipment from renowned manufacturers

We offer the following types of analyses:

  • UV/VIS spectrophotometry with spectrum reading
  • pH and conductivity measurements
  • density measurements with pycnometers or densitometers
  • viscosity determination using a rotational rheometer
  • refractive index measurements
  • titration using an automatic digital burette and potentiometric titration
  • determination of water content using the Karl-Fischer method

We perform chromatographic analyses using high-performance liquid chromatography with UV-VIS (DAD), RI, ELSD, and FLD detection and gas chromatography with a photoionisation detector (PID) and headspace sampler.

We offer measurement of the size of particulates, emulsions and aerosols in a wide range (0.6 nm – 2000 μm) by laser diffraction with dry and wet dispersion. We also carry out microscopic particle shape tests and zeta potential measurements.

We offer stability tests along with storage of products in climatic chambers under controlled conditions at 25°C/60% RH, 30°C/65% RH and 40°C/75% RH, as well as in the photostability test chamber in accordance with the requirements of the ICH Q1 guideline. During product life tests, we perform physicochemical analyses in accordance with the customer’s specification.

Stability tests can be preceded by a preliminary verification of the compatibility of an active substance with excipients in the calorimetric test.

NOVASOME R&DC offers high quality R&D services in the field of pharmaceutical availability research. The unique knowledge of our experts is based on years of experience in working on the development of in-vitro methods for medicinal products in the form of tablets, soft and hard capsules, powders, granulates, suspensions, ointments, creams and gels.

Thanks to our experts, who bring together extensive knowledge in the field of analytics, pharmaceutical technology and clinical trials, we offer the highest-quality services in the field pharmaceutical availability research in relation to:

  • development of differential research methods (both manual and automatic)
  • use of media simulating in vivo conditions (so-called biorelevant media) in the research
  • performing release tests according to the customer’s methodology
  • validation and revalidation of research methods
  • transfer of research methods
  • evaluation of the similarity of release profiles with the use of validated statistical methods dependent on and independent of the model (including similarity factor (f2), Weibull distribution, Mahalanobis distance)
  • preparation of registration documentation (CTD module 3) and support during the entire registration process (including in the case of foreign registers)
  • consulting services and training
  • assistance with audits
  • broadly understood troubleshooting

As the only company in Poland, we offer testing in a modern machine park, which includes:

  • apparatuses I and II according to Ph. Eur. with an integrated video system
  • flow apparatus (IV according to Ph. Eur.)
  • apparatus for testing the release of an active substance from chewing gum (type B according to Ph. Eur.)
  • Franz cells

APPARATUS FOR TESTING THE RELEASE OF AN ACTIVE SUBSTANCE FROM CHEWING GUM

NOVASOME R&DC offers tests for the release of a substance from chewing gum and tablets using a B-type apparatus according to the European Pharmacopoeia (2.9.25). The ERWEKA DRT‑3 apparatus is a unique solution dedicated to this type of research, due to the fact that the vertical movements of the lower “jaws” in combination with the rotating movement of the upper “jaws” enable the mapping of the chewing process.

Thanks to these solutions, we offer:

  • Analytical support during research and development work on new products in the form of chewing gum and tablets.
  • Performing research in accordance with the methodology provided by the customer.
  • Comprehensive development of methods along with their validation.

We also offer research design using the apparatus for testing release from chewing gums, proving a qualitative advantage over the competition’s products in the pharmaceutical and food sectors.

FLOW APPARATUS

NOVASOME R&DC offers tests for the release of an active substance by the flow method using the SOTAX CE 7 smart flow apparatus, in accordance with USP IV.

We offer tests in both open and closed systems for tablets, capsules, powders, granulates, suppositories, implants and semi-solid medications (ointments, creams, gels).

Due to the option of working in an online system, we offer tests for modified-release products with a sampling rate up to once every two minutes.

FRANZ CELLS

NOVASOME R&DC also offers testing of epidermal preparations, for example, in the form of ointments, creams and gels, using permeability tests in Franz cells. We carry out the tests in accordance with the applicable USP 1724 guidelines. Diffusion tests in Franz cells are a recognised method of testing under in vitro conditions, used to assess the effectiveness of permeation of the in vivo formulations. The essence of cell operation is the diffusion of an active substance through a synthetic membrane, or human or pig skin, between the donor part containing the formulation tested and the acceptor cell. A set consisting of Franz cells in combination with a magnetic stirrer and a circulation thermostat makes it possible to conduct the experiment at a constant temperature, in the entire volume of the acceptor cell. The results of the experiment enable determination of the effectiveness of the developed preparation based on the concentration of the active substance in the acceptor medium

  • X-ray analyses

We perform qualitative and quantitative analyses of elements using X-ray fluorometer (XRF) and X-ray powder diffractometer (XRPD) analyses by reflection and transmission methods (film and capillary).

  • Mass spectrometry analyses

We perform measurements using a high-resolution mass spectrometer (HRAM) combined with a two-dimensional chromatograph, allowing for offline fraction separation.

  • Particle measurements

We carry out surface, size and volume tests of pores using gas adsorption (BET, BJH), as well as water activity and sorption analysis using DVS and DDI techniques. We also test the contact angle of the substance using the sessile drop technique, and determine the surface energy.

  • DSC/TGA thermal analyses

We perform measurements using a differential scanning calorimeter in the temperature range from -60°C to 500°C and thermogravimetric analyses up to 1100°C.

  • Raman microscopy analyses

We perform chemical imaging analyses using the Confocal Raman Microscope with the possibility of point, line, surface (2D) and in-depth measurements (3D) to determine the distribution of active substances and excipients, product manufacturing technology and polymorphic form of active substance or excipient in the product, etc.