Near infrared spectroscopy and process analytical technology to master the process of busulfan paediatric capsules in a university hospital

Critical review of near-infrared spectroscopic methods validations in pharmaceutical applications

“…NIRS method validated following the ICH Q2 guideline can be found for the determination of water in pharmaceutical processes or drug products [45,46], API in various drug products [17,18,[45][46][47][48][49][50][51][52][53][54][55][56][57][58] or in various production steps [59,60], for the quantification adjuvant in vaccines [61], for the quantification of excipients [18,51] of antifungal and antibacterial agents [62]. From these applications it can be seen that the validation requirement imposed by ICH Q2 document is applicable to NIRS methods.…”

Challenging Near InfraRed Spectroscopy discriminating ability for counterfeit pharmaceuticals detection

“…HPLC determinations revealed correct absolute strengths of API in all these imitations, but confirmed the API weight percentages gradient from the Class 7 (6.2%, w/w) to the classes 3 + 4 (6.9 and 7.4%, w/w, respectively), with intermediate relative strengths for the other classes (1, 2, 5, 6: 6.3 and 6.4%, w/w). Nevertheless, to get access to quantitative information from NIRS spectral data, calibrations have to be validated with different strength samples [16,35] quantified with a validated reference method [36][37][38].…”

Rapid method to study the sedimentation of a pigment suspension prepared for coating fluids

“…The other results were calculated from the concentration ratios. The fitting revealed that these curves can be described by the Weibull model [19]. A non-linear fitting approach with the following equation was applied:…”