The analyses are performed with the use of the Zetasizer Nano ZS device by Malvern Instruments, which allows us to carry out measurements of the particle sizes (DLS technique), particle mass (SLS – Static Light Scattering technique) and the zeta potential (ELS – Electrophoretic Light Scattering technique).
By having additional equipment – Autotitrator MPT-2 we offer the possibility to perform automated measurements of the particle sizes/ zeta potential in the pH function or the additives concentration. This is a highly helpful solution when, among others, in the development of the composition of the medicinal product and studying the impact of various additives on the stability of formulation.
The measurement scopes of particle sizes are as follows:
from 0.3 nm to 10 µm for the DLS technique,
from 3.8 nm to 100 µm for the measurements of the zeta potential with the use of the ELS technique,
from 980 Da to 20 MDa for the measurements of the particle mass with the use of the SLS technique.
The scope of concentration of the sample ranges from 0.1 ppm to 40% w/v and the temperatures of measurements are up to 120°C.
We offer the possibility to perform analyses in accordance with the procedures provided to us by the customer, including the transfer and validation of method as well as development and validation of the methods in accordance with the internal IBA procedure.
We ensure that performed analyses and the prepared documentation are done in accordance with the requirements of pharmacopoeia (USP, Ph. Eur., FP), recommendations of the International Conference on Harmonisation (ICH), the requirements of the European Medicines Agency (EMA) and the American Food and Drug Administration (FDA).