Metrohm QTRam Portable Raman spectrometer

Significance of the Topic

Content uniformity testing is fundamental to ensuring accurate dosing and patient safety in pharmaceutical solid dosage forms. Non-destructive, rapid analytical methods streamline quality control workflows, reduce waste and accelerate time-to-market. Transmission Raman spectroscopy enables volumetric analysis of tablets and capsules without sample preparation, aligning with regulatory requirements and modern Quality by Design (QbD) principles.

Objectives and Overview of the Study

This application note presents the QTRam® portable transmission Raman spectrometer built on B&W Tek’s STRaman® technology. It demonstrates how the device performs quantitative analysis for content uniformity of finished dosage forms, supports formulation development and aids in counterfeit detection by measuring active pharmaceutical ingredient (API) concentration directly through packaging.

Methodology

The QTRam employs transmission Raman spectroscopy to probe entire sample volumes. Users select the appropriate model and calibration using 21 CFR Part 11 compliant software. Quantitative predictions are generated through chemometric models developed in BWIQ® and implemented in BWAnalyst®. The workflow guides operators through method building, validation and routine analysis, yielding results in seconds.

Used Instrumentation

The core system components include:

• QTRam® spectrometer (model BWS475-785H-CU) with a 785 nm laser delivering >420 mW at the sample
• QT-Sampler® and two customizable sample holders for tablets, capsules or gels
• Tablet PC with BWAnalyst® touchscreen software (21 CFR Part 11 compliant)
• BWIQ® multivariate analysis software for quantitative model development
• Standard accessories: laser safety goggles, power adapter, BWSpec® exploratory software

Main Results and Discussion

Key performance highlights include high-throughput analysis over large sample volumes, enabling quantitative determination of API, excipient ratios, crystallinity and polymorphic forms in single measurements. The method requires no consumables or sample preparation, delivering rapid results that comply with USP <905> content uniformity guidelines.

Benefits and Practical Applications

Practical advantages of QTRam® analysis:

• Rapid, non-destructive quantification of one or multiple ingredients in seconds
• At-line or laboratory deployment with portable form factor
• Elimination of sample prep steps, consumables and disposal costs
• Secure data management with electronic signatures and full audit trails
• Support for formulation development, routine quality control and counterfeit screening

Future Trends and Opportunities

Advances in chemometric algorithms and machine learning are expected to enhance model robustness and expand applicability to complex combination products. Integration with process analytical technology (PAT) platforms will enable real-time monitoring in continuous manufacturing. Miniaturization and wireless connectivity could further extend at-line deployment into production environments and packaging lines.

Conclusion

The QTRam® portable transmission Raman spectrometer offers a versatile solution for rapid, accurate content uniformity testing and formulation analysis. Its non-destructive approach, regulatory-compliant software and portability make it an effective tool for pharmaceutical development, QA/QC and anti-counterfeiting measures.

References

No additional references were provided in the source document.