Content Uniformity and Solvatomorph Determination by PX2+

Content uniformity and solvatomorph content in pharmaceutical solid drug products and intermediates are common critical quality attributes for small molecule final drug product applications.  Sensitive real-time fluorescence sensing is well suited for such applications when the active pharmaceutical ingredient (API) or its solvatomorphic derivative exhibits native fluorescence.  A plethora of API exhibit autofluorescence at a single excitation-emission wavelength combination.1, 2  Moreover, determination of fluorescent solvatomorphs is also well established via a suitable excitation-emission wavelength combination.3, 4  Both real-time content uniformity and solvatomorph determination has been demonstrated and established for routine use in GMP manufacturing via our PX2+ photometer equipped with a front surface probe.5-7  This compact process analytical technology enables rapid, sensitive and low content determination of APIs and their derivatives with modest process development as well as minor mechanical and IT integration criteria.  The technology has been used across solid oral dose and inhaled pharmaceutical GMP applications.


  1. Albert-Garcia, J. R.; Antón-Fos, G. M.;  Duart, M. J.;  Lahuerta Zamora, L.; Martínez Calatayud, J., Theoretical prediction of the native fluorescence of pharmaceuticals. Talanta 2009, 79 (2), 412-418.
  2. Al-Saleh, W. M. Laser and Light induced fluorescence of Some Biofluorophores at Different pH. King Saud University, Riyadh-Saudi Arabia, 2008.
  3. Brittain, H. G.; Elder, B. J.;  Isbester, P. K.; Salerno, A. H., Solid-State Fluorescence Studies of Some Polymorphs of Diflunisal. In Pharmaceutical Research, Springer Netherlands: 2005; Vol. 22, pp 999-1006.
  4. Abdel-Shafi, A. A.; Al-Shihry, S. S., Fluorescence enhancement of 1-napthol-5-sulfonate by forming inclusion complex with [beta]-cyclodextrin in aqueous solution. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy 2009, 72 (3), 533-537.
  5. Lai, C. K.; Cooney, C. C., Application of a Fluorescence Sensor for Miniscale On-line Monitoring of Powder Mixing Kinetics. Journal of Pharmaceutical Sciences 2004, 93 (1), 60-70.
  6. Karumanchi, V.; Taylor, M. K.;  Ely, K. J.; Stagner, W. C., Monitoring Powder Blend Homogeneity Using Light-Induced Fluorescence. AAPS PharmSciTech 2011, 12 (4), 1031-1037.
  7. Igne, B.; Baldasano, C. N.; Airiau, C., Feasibility of Using Light-Induced Fluorescence Spectroscopy for Low-Dose Formulations Monitoring and Control. Journal of Pharmaceutical Innovation 2020.

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