Stability in Solution and Forced Degradation Studies Process Intermediate Compound A

1 Stability in Solution and Forced Degradation Studies (Process Intermediate Compound A) 

In the following case study, during the course of the initial method development for an intermediate, some late eluting species (18-20 minutes) were presumed to be forming in the sample solutions (prepared in acetonitrile) in 

Two samples of the intermediate were prepared using acetonitrile and methanol as the diluents. Each sample preparation was immediately analyzed using an autosampler-tray-cooler-equipped HPLC for the initial control time-point, and portions were also stored under ambient conditions (clear volumetric flask and ambient room lighting) and under refrigerated conditions for 50 hours. 

Stable in methanol than in acetonitrile however, in both solvents, the sample solutions are stable in the refrigerator (4°C) for up to 50 hours. Solution light stability studies (dark and light chamber) in both solvents at ambient temperature were also performed in order to further determine whether the formation of the degradation products is photocatalyzed or generated at ambient temperature ( 25°C). 

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