Sanofi’s solvent selection guide helps chemists in early development select sustainable solvents that will be accepted in all production sites. Solvents are divided into four classes, from “recommended” to “banned”. This ranking is derived from Safety, Health, Environmental, Quality, and Industrial constraints. Each solvent has its own ID card that indicates the overall ranking, H, S & E hazard bands, as well as its ICH limit, physical properties, cost, and substitution advice.

In the pharmaceutical industry, controlling the crystallization process of active pharmaceutical ingredients (API) is crucial to ensure chemical quality and physical properties. Process analytical technologies (PAT) provide a large number of tools that provide information in real-time to allow mastery of the final solid chain. In this paper is described how attenuated total reflection ultraviolet (ATR-UV) spectroscopy can be used to monitor concentration. Besides its classical application to UV-absorbing molecules, it will be shown how, in principle, it may be applied to molecules that do not absorb at UV wavelengths.

Cocrystallization as a purification step was the only way to isolate an active pharmaceutical ingredient with acceptable chemical and physical specifications. The process design controlling chemical quality and polymorphism issues is described, from the thermodynamics of cocrystal formation and cleavage, to microscale data acquisition, to laboratory scale-up and transfer to the pilot plant.

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