Quality Control Chemical Laboratory
The Chemical Quality Control (QCC) laboratory consists of approximately 30 well-educated highly competent coworkers. We are experts at Analytical Chemistry within drug development. The department is divided into 3 teams. The employees hold positions as Assistant, Analyst, Senior Analyst, Team manager and Manager.
Focus and responsibilities
Release testing of incoming materials, semi-finished and finished products.
Method validation, sampling plans and specifications for testing
Stability studies, including writing protocols, performing chemical analyses and writing reports.
Qualification and validation of instruments used at the department (URS, IQ, OQ, PQ).
Taking part in most of the projects for new products and all kind of investigations concerning chemical analyses at Rechon.
Cleaning methods for products.
Writing and review of MAA/NDA and IMPD/IND module 3.
Services and Capabilities
- Release testing of products
- Raw materials testing according to pharmacopoeias: Ph Eur, USP, JP, BP
- Container, packaging materials and label testing
- Stability testing and storage according to ICH guidelines
- Method establishment (adjustment, validation, transfer) according to ICH guidelines for phase I/II, III/IV
- Characterisation of products during development (phase II/III)
- Shipping studies
- Water analyses: Monograph Purified water and Water for Injection according to pharmacopoeia Ph Eur/USP
Analytical techniques and Pharmacopoeia analyses the laboratory is trained in:
- High Performance Liquid Chromatography (HPLC/UPLC): RP-HPLC, SEC. Detectors used are UV, Diode Array and Refractive Index.
- Gas Chromatography: GC-Headspace/FID, GC-FID
- Fourier-transform infrared spectroscopy (FTIR)
- UV/VIS spectrophotometry
- Dissolution testing USP 1, 2
- Total Organic Carbon (TOC)
- Titration and Karl Fisher titration (coulometric and volumetric)
- Melting point
- Particle analysis (method 1)
- Optical rotation
- Wet chemistry
Anna Löfqvist Svensson