Process analytics

Pharmaceutical development and manufacturing rely on UV-Vis, NIR and Raman spectroscopy at almost every step, from raw material receipt to final release. The United States Pharmacopeia includes general chapters for each technique, and the FDA’s 2004 guidance on Process Analytical Technology encourages in-line measurement during production. Compact spectrometers bring these methods into laboratory instruments, process analyzers and OEM systems.

Chromatography and dissolution testing

HPLC diode-array detectors record full UV-Vis absorbance spectra as compounds leave the column. The spectrum confirms peak identity and reveals co-eluting impurities, and absorbance at a chosen wavelength gives the concentration. These detectors typically cover 190 to 800 nm and demand low noise and low stray light at the short-wavelength end.

Dissolution testing tracks how quickly a tablet or capsule releases its active ingredient. Fiber-optic UV probes placed in each vessel measure absorbance at set intervals, which removes manual sampling and gives a finely sampled release profile. A multichannel or switched setup covers six or more vessels with consistent calibration between channels.

Process Analytical Technology

NIR spectroscopy monitors blend uniformity in real time. A probe on the blender or feed frame records spectra as powder moves past, and the spread between consecutive spectra shows when the blend has reached a stable state. NIR also follows moisture during fluid-bed drying and granulation, using the strong water band near 1940 nm. Coating thickness on tablets and content uniformity of finished units can be predicted from NIR spectra with a validated calibration model.

Raman spectroscopy adds chemical specificity. Sharp vibrational bands distinguish polymorphs of the same active ingredient, which matters for solubility and stability. Raman also monitors reactions and crystallization in solution, because water gives only a weak Raman signal.

Raw material identification

Incoming raw materials are identity-tested before use, and EU GMP generally expects identification of every container. Handheld and benchtop NIR and Raman instruments compare each spectrum against a reference library. Raman measurements can often be made through glass or plastic packaging, which speeds the receiving process and keeps containers sealed.

Cleaning verification

Equipment is checked for residue between product changeovers. UV absorbance of rinse samples provides a fast screen for residual active ingredient when the compound has a suitable chromophore. Spectroscopic methods complement total organic carbon and HPLC testing in a cleaning validation program.

Evolve Sensing for pharmaceutical applications

• SmartEngine: UV-Vis-NIR platform for dissolution, concentration and cleaning measurements.
• GoldenBullet: NIR for blend, moisture and raw material analysis.
• ClearPeak Raman: compact Raman for material identification and polymorph studies.
• SDK support and OEM configuration for analyzer and instrument manufacturers.

We are happy to help with spectrometer selection for a laboratory method or a process installation.