Identification of Additives used in the Pharmaceutical and Food Industries with the NanoRam Handheld Raman Spectrometer

Importance of the Topic

Raman spectroscopy offers a fast, non-destructive approach for verifying raw materials and detecting counterfeit products in pharmaceutical and food industries. Recent miniaturization of components has enabled handheld instruments to deliver laboratory-grade performance in production and quality-control settings, addressing the need for high molecular selectivity and rapid decision making.

Objectives and Overview of the Study

This work evaluates the capability of a handheld NanoRam® Raman spectrometer to distinguish between common white powders used as binders, fillers, sweeteners and supplements. The study focuses on cellulose, hydroxypropyl methylcellulose (HPMC), lactose, maltodextrin and calcium monohydrogen phosphate dihydrate.

Methodology and Instrumentation

The device employs a 785 nm laser, crossed Czerny-Turner spectrograph and thermoelectrically cooled CCD detector at 18 °C. Key operating parameters include:

• Spectral range: 175–2900 cm⁻¹
• Resolution: ~9 cm⁻¹
• Detector array: 2048 pixels (14×200 µm each)
• Acquisition time: < 20 s per sample

Calibration methods were created by collecting at least 20 spectra for each pure reference material to capture sample variability. Proprietary software compares each unknown spectrum to stored methods, generating a P-value for a pass/fail decision and, if necessary, a Hit Quality Index (HQI) for probable identification.

Main Results and Discussion

The NanoRam system accurately confirmed each reference material in under 20 seconds. Pass rates for matching materials yielded P-values close to 1.00. When tested against mismatched methods, P-values dropped sharply (often below 10⁻³), triggering spectral library searches that returned HQI scores above 99% for correct identification. This dual-step approach (method match plus library search) ensured unambiguous differentiation among structurally similar powders.

Benefits and Practical Applications

• Rapid, on-site verification of incoming raw materials and final products
• Elimination of sample destruction and complex preparation
• Improved consistency and throughput in quality-control workflows
• Reduced reliance on large laboratory instruments and offsite testing

Future Trends and Applications

Advances in detector cooling, miniaturized optics and intelligent algorithms will enhance sensitivity and selectivity for more challenging samples (e.g., fluorescent compounds). Integration with cloud-based libraries and real-time data analytics will further streamline compliance and supply-chain security. Multi-modal handheld platforms combining Raman with complementary techniques may expand coverage of complex matrices.

Conclusion

The NanoRam handheld Raman spectrometer delivers laboratory-comparable performance for rapid, reliable identification of pharmaceutical and food additives. Its combination of fast acquisition, robust calibration methods and on-board spectral libraries supports unambiguous material verification in cGMP environments.

Reference

B&W Tek, Identification of Additives used in the Pharmaceutical and Food Industries with the NanoRam Handheld Raman Spectrometer, Application Note 410000028-A (2012).