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Comparison of the Crystal Chemistry, the Process Conditions for Crystallization and the Relative Structural Stability of Two Polymorphic Forms of NG-monomethyl-l-arginine Hydrochloride

Control of polymorphic form is critical in pharmaceutical ingredient manufacture. Impurities determine crystal nucleation and growth, and industry has a need to understand how impurities are linked to the selection of crystal form. This paper reports an approach which combines, in a novel way, examination of solid-state chemistry together with process analytical and thermochemical data to relate the expression of crystalline form for an active pharmaceutical ingredient to the underlying molecular structure. Recently a broad, across-sector industrial consortium (including Pfizer, Syngenta and Infinium) has been formed to exploit the approach demonstrated in this publication and develop a bespoke computational tool.