Seragon Pharmaceutical’s sophisticated drug development process relies on our analytical chemistry procedures to safeguard the quality, efficacy, and safety of our novel medicines. Our chemists work closely with Seragon’s product team to assess the data from our analytical procedures, offering their professional guidance on the best course of regulatory action to take.
Analytical chemistry is an increasingly crucial part of the pharmaceutical pipeline process, as it plays a key role in detecting risks and quality issues throughout any stage in product development. We highlight the importance of analytical assessments in our pipeline by investing in the latest analytical techniques such as electrochemical methods, spectroscopy, and other applications in pharmaceutical development.
Our facilities span the full range of work from early planning, design, technical expertise through to manufacturing in a fully compliant, state-of-the-art environment. Seragon offers comprehensive testing services per GMP and pharmacopoeia (USP, EP, BP and JP) standards. Our analytical chemistry team is equipped to support all areas of necessary testing for raw materials, APIs, finished products, packaging materials and medical devices to ensure quality control and delivery.
At Seragon, we perform a complete analysis of each lot of raw material received, something that we uphold to produce products that are tested for purity, identity, and quality.
Some of the facilities we employ include:
- Physicochemical Properties
- Identity and Purity
- Assays and chemical tests
- Identification of active ingredients and impurities
- Physico-chemical determinations
- Particle size
- Osmolality and osmolarity
- Loss on drying
- Limit tests
- Heavy metals
- Residual solvents
- Volatile organic compounds (VOC)
- Organic volatile impurities (OVI)
- Water testing for pharmaceutical purposes and controlled process environments (e.g. TOC, conductivity)