Baishya, Himankar published the artcileLyophilization cycle comparison and scale-up of esomeprazole sodium for injection between lab scale and scale-up batches vs FDM study, Quality Control of 161796-78-7, the publication is International Journal of Pharmaceutical Sciences and Research (2016), 7(11), 4407-4413, database is CAplus.
Lyophilization also known as freeze drying is a process in which water is removed from a product after it was frozen and placed under a vacuum, allowing the ice to change directly from solid to vapor without passing through a liquid phase. The process consists of three sep., unique, and interdependent processes; freezing, primary drying (sublimation), and secondary drying (desorption). Esomeprazole sodium for Injection 20 mg and 40 mg formulation was developed by optimized Lyophilization cycle. The objective of the research work was to compare the lyophilsation process cycle between Lab scale and scale up batches. The collapse temperature (Tc) for the product was identified using Freeze-drying microscope (FDM). During manufacturing the samples were exposed to above said collapse temperature to study the impact on product quality. Lab scale manufacturing was executed in Tofflon Lyophilizer 0.5 and scale-up batches were executed in Tofflon Lyophilizer 13. The Lyophilisation cycle and anal. results for both the batches were compared.
International Journal of Pharmaceutical Sciences and Research published new progress about 161796-78-7. 161796-78-7 belongs to imidazoles-derivatives, auxiliary class Membrane Transporter/Ion Channel,Proton Pump, name is Sodium (S)-6-methoxy-2-(((4-methoxy-3,5-dimethylpyridin-2-yl)methyl)sulfinyl)benzo[d]imidazol-1-ide, and the molecular formula is C17H18N3NaO3S, Quality Control of 161796-78-7.
Referemce:
https://en.wikipedia.org/wiki/Imidazole,
Imidazole | C3H4N2 – PubChem