NanoRam® -1064 Fast Facts: Raw Material Verification of Cellulose and its Derivatives

Significance of the topic

Cellulose and its derivatives form key excipients in pharmaceutical formulations, used in tablets, creams, gauze and more. Reliable identification of these materials is critical for quality control, but conventional handheld Raman systems operating at 785 nm often suffer from overwhelming fluorescence that obscures characteristic signals. The use of a 1064 nm excitation source offers a path to minimize fluorescence interference and enable rapid, non-destructive verification of cellulose raw materials.

Objectives and study overview

The primary goal of the study was to evaluate a handheld Raman spectrometer (NanoRam-1064) for specific and accurate identification of cellulose and four common derivatives: methyl cellulose, sodium carboxymethyl cellulose, cellulose acetate and ethyl cellulose. By developing multivariate identification models for each material, the work aimed to demonstrate specificity, robustness and suitability for routine pharmaceutical quality assurance.

Methodology and instrumentation

A NanoRam-1064 unit outfitted with a point-and-shoot adaptor was employed to acquire Raman spectra through sealed Whirl-Pak sample bags. Laser power was set at 90 % of maximum output (approximately 380 mW) at 1064 nm to suppress fluorescence.

• Sample set: five spots on each of five materials (cellulose and derivatives) to build chemometric models.
• Analysis mode: Identification workflow based on multivariate statistics and p-value thresholds (default 0.05 significance level).
• Validation: Each sample was tested against every model to assess specificity (pass if p > 0.05, fail if p < 0.05).

Key results and discussion

All identification models exhibited high specificity, correctly passing only the target material and rejecting other derivatives. The use of 1064 nm excitation markedly reduced background fluorescence compared with a 785 nm laser, revealing distinct Raman bands for cellulose materials. Statistical evaluation based on p-values confirmed reliable discrimination between similar polysaccharide structures.

Benefits and practical applications

The NanoRam-1064 platform enables rapid, in situ raw material verification without sample preparation or reagent use. Compliance with major pharmacopeial Raman chapters and FDA 21 CFR Part 11 record management ensures audit-ready workflows. Laboratories can streamline quality control of cellulose-based excipients, reduce laboratory footprint and improve throughput.

Future trends and applications

• Expansion of chemometric libraries to cover a broader range of excipients and formulation components.
• Integration with artificial intelligence for automated spectral interpretation and anomaly detection.
• Miniaturization and connectivity improvements for real-time, cloud-based quality monitoring.
• Adaptation to continuous manufacturing lines for online process control.

Conclusion

The handheld NanoRam-1064 spectrometer effectively overcomes fluorescence challenges in cellulose analysis, offering a robust, non-destructive approach for pharmaceutical raw material verification. Its multivariate identification models achieve high specificity across cellulose derivatives, supporting enhanced quality assurance practices.

References

• B and W Tek LLC. Raw Material Verification of Cellulose and its Derivatives. Technical Note 410000047 A, January 2020.