Research and Development Laboratory
he company has its own, independent Research and Development Department which develops prototypes of new products and methods of their quantitative and qualitative analyses. These methods are then transferred to the Quality Control Laboratory.
Analytical methods are developed and validated at the Research and Development Department:
- Tests and identification of API, API contamination, antioxidants, preservatives in the preparation
- Particle size distribution
- Testing particle density and viscosity
- Selecting a sterilisation method (steam, dry heat, ionizing radiation sterilisation, sterile filtration or aseptic processing)
- Selecting an appropriate immediate packaging – initial stability tests
- Photostability tests
The Research and Development Department is responsible for finding active pharmaceutical ingredients of appropriate quality and immediate packagings, and for the preparation of the quality part of the registration dossier.
Wide range of tests
The main panel of the Vet-Agro Quality Control services includes the following tests:
- active substance contamination profile,
- active substance content,
- solvent residues in the active substance,
- particle size of loose substances and suspensions,
- microbiological purity and sterility,
- bacterial endotoxin content.
Vet-Agro laboratories ensure high quality of the services performed and test timeliness. The tests performed are based on validated methods and compliant with ICH and GMP guidelines.
High quality equipment
Physico-chemical and microbiological laboratories are equipped with high quality devices for analyses, both instrumental and classical ones, e.g.:
- liquid chromatographs from Waters (Acquity HClass and Arc HPLC) and Agilent (Infinity II) with PDA, ELSD and electro-chemical detectors,
- GC gas chromatograph with headspace from Agilent,
- Titrino and Titrando sets for potentiometric titration from Metrohm,
- set for volumetric of water with the Karl-Fischer method from Metrohm,
- UV-Vis Helios γ and Helios Ω spectrophotometers from Thermo Scientific,
- FTIR IR-Affinity-1 spectrophotometer from Shimadzu,
- Ramana Progeny spectrophotometer from Rigaku,
- particle size analyser using laser diffraction Mastersizer 3000 from Malvern,
- TOC Anatel PAT 700 analyser from Beckman Coulter
- projection microscopes with a video recorder and camera and data processing software,
- Pyros Kinetix Flex tube reader from Associates of Cape Cod.
