Active pharmaceutical ingredients development report requirements

By the time an active pharmaceutical ingredient (API) is made available to an analytical chemist in the formulation development group, most or all of the physical characteristics of an API has already been studied and the information should be available in some sort of a report from the drug substance group or preformulation group. Some of the key parameters that an analytical chemist in formulation development requires from such a report are the solubility and solution stability. 

The product mandate for this project required that the active pharmaceutical ingredient (API) needed to be a single isomer. Methodology reported in the literature, for the general class of which cefovecin is a member, provided an epimeric diastereoisomer mixture of 3 (which became cefovecin sodium) and 4 (UK-287076 sodium). Both compounds are potent, but the (S) absolute configuration at the tetrahydrofuran (THF) C-2 center was selected for commercial development (Figure 11.1). 

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