Real-Time Release

The first demonstration of solid state fluorescence of API dates back to 1961, while its in-line use for final drug product manufacturing was not demonstrated until recently." While in its infancy as a process analytical technology for real-time monitoring and product parametric real-time release, the applications identified and in some instances demonstrated include (i) blend endpoint API content nniformity detection " (ii) segregation monitoring or API content at various process critical control points and (iii) at-line tablet content uniformity determination. The fundamentals of solid-state luminescence spectroscopy for pharmaceutical solids has been covered by Brittain."... 

Increasing the possibility of real-time release of product. 

Reduced and even eliminated some finished product release testing (achieved real-time release)... 

Commercial product manufacturing Cbemometric PAT Real time release test (content uniformity, komogenedy, phase distribution, crystaIBnity)... 

Gruenhagen JA, LoveU P, Moroz LL, Yeung ES. Monitoring real-time release of ATP from the moUuscan central nervous system. J Neurosci Meth 2004 139 145-52. 

D. Process Control, Design Space, and Real-Time Release... 

Cogdill, R. P., Anderson, C. A., Delgado, M., Chisholm, R., Bolton, R., Herkert, T, Afnan, A. M. and Drennen III, J. K. Process analytical technology case study Part II. Development and validation of quantitative near-infrared calibrations in support of a process analytical technology application for real-time release. AAPS PharmSciTech. 6(2) E273-E283, 2005. 

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