Metrohm NanoRam handheld Raman spectrometer

Importance of the Topic

Raman spectroscopy is a vital tool for non­destructive, rapid identification of pharmaceutical raw materials and intermediates. Its ability to verify active pharmaceutical ingredients (APIs), excipients and polymers in transparent containers without sample preparation accelerates quality assurance processes and supports cGMP compliance.

Objectives and Overview of the Study

This summary reviews the capabilities and applications of the NanoRam handheld Raman analyzer. Key goals include assessing its performance for material identification, evaluating data quality and reproducibility, and illustrating its integration into regulated manufacturing workflows.

Methodology

The NanoRam employs a 785 nm laser and TE-cooled CCD detector to collect spectra across 176 cm⁻¹ to 2900 cm⁻¹. Data are processed using multivariate classification and p-value statistics for robust identification. The system allows library building from multiple lot spectra, method transfer between instruments, and mixture analysis to detect multiple components in complex samples.

Used Instrumentation

• Excitation wavelength: 785 nm, laser power up to 300 mW (software adjustable)
• Spectral resolution: ~9 cm⁻¹ and range 176 cm⁻¹–2900 cm⁻¹
• Detector: TE-cooled linear CCD array
• Display: High-brightness OLED touch screen
• Data interfaces: Ethernet, Wi-Fi, barcode scanner
• Battery: Rechargeable Li-ion, >5 h runtime
• Operating range: –20 °C to +45 °C; IP64 rating
• Standard accessories: point-and-shoot adaptor, vial holder, immersion probe, bottle adapter

Key Results and Discussion

Robust hardware and high dynamic range deliver low-noise spectra, enabling reliable identification of weak Raman scatterers. TE cooling enhances stability in variable environments. Method and library transfers ensure reproducibility across devices. Sampling adapters support powders, solids, liquids and gels, facilitating rapid in-situ measurements in labs, warehouses, loading docks or the field. Nanogram-level mixtures are resolved via multivariate models, providing comprehensive sample profiling.

Benefits and Practical Applications

• Non-destructive testing through transparent packaging preserves sample integrity
• Intuitive software (NanoRam OS and PC-based NanoRam ID) streamlines method creation, data storage and LIMS integration
• Compliance with USP <858>, EP 2.2.48, Chinese pharmacopeia and 21 CFR Part 11 supports regulatory audits
• Portable design and accessories allow deployment by non-technical users across manufacturing sites

Future Trends and Applications

Advancements may include AI-driven spectral interpretation, expanded material libraries (e.g., polymers, botanicals), enhanced networked data management and IoT connectivity. Miniaturized detectors and improved algorithms will further lower detection limits and broaden field applications.

Conclusion

The NanoRam handheld Raman analyzer offers a versatile, compliant platform for rapid identity verification of raw materials in pharmaceutical and industrial settings. Its combination of high data quality, user-friendly interfaces and robust sampling options supports streamlined workflows and regulatory adherence.

References

• United States Pharmacopeia, Raman Spectroscopy <858>
• European Pharmacopeia, Chapter 2.2.48
• People’s Republic of China Pharmacopeia, Raman Spectroscopy Guidelines
• 21 CFR Part 11 and Part 1040.10