Efficient water determination accelerates API development
Contract development and manufacturing services for active pharmaceutical ingredients (APIs) must meet the requirements of customers and regulatory bodies alike. In the process control lab of the CARBOGEN AMCIS AG pilot plant in Bubendorf, Switzerland, accurate and efficient Karl Fischer titration workflows for water determination offer fast and reliable decision making for process control, as Lab Manager Loïc Gasnier explains.
DURING THE development of new types of active pharmaceutical ingredients (APIs) or medicinal products, scale-up at a pilot plant is an important proof of concept. Offering the opportunity to assess the efficacy of a synthesis and refine it prior to production stages, these facilities are both critical and integral to development processes.
Various analyses of batches are essential to success, with one of the central quality parameters assessed in pilot plants being water content. Water may be found in raw materials, where it can impact blending, granulation and synthetic reactions, as well as intermediate and final products. In finished tablets and capsules, water content can alter the mechanical strength, solubility and stability of the product.