In recent years, the rapid development of instrumental analytics has resulted in a constant stream of new requirements relating to both the characterisation of active agents and quality control. This has primarily affected the pharmaceuticals industry. The authorisation and control authorities continue to issue corresponding directives aimed at ensuring that these constantly improving analytics are implemented at the product development stage. With this objective in mind, we currently feature the following equipment:
- 14 HPLC systems with various different detectors (UV, coulometric detection, refractometers, diode array detectors and fluorometers)
- LC/MS/MS systems from the following companies: Applied Biosystems (API 4000)
- GC/MS from Agilent
- Camag DC technology with scanner and Win-Cats software
- 5 devices for testing release from solid oral dosage forms and suppositories
- Equipment for determining general properties such as dimensions, average mass, loss on drying, deterioration, compressive strength, visible particles, slip melting point and many others
- Equipment for carrying out stress tests in accordance with ICH guidelines (e.g. light test)
- Climatic chambers for carrying out stability tests on finished pharmaceutical products under ICH conditions, as well as a variety of different climatic cabinets for special storage conditions (storage temperatures and humidity are recorded)
- Storage possibilities at subzero temperatures (- 20°C, - 80°C)
- Storage of the test sample (including narcotic substances) in qualified and secured climatic chambers
All of our testing equipment is subject to constant monitoring by our quality assurance unit. All devices are qualified and validated and comply with the requirements of 21 CFR Part 11.