QTRam Portable Raman System for Content Uniformity

Significance of the Topic

Transmission Raman spectroscopy offers a non-destructive approach to assess the chemical composition of bulk pharmaceutical products rapidly. By probing large sample volumes, it ensures reliable content uniformity testing and supports critical quality control measures in pharmaceutical manufacturing.

Objectives and Overview of the Application Note

The primary goal of this application note is to introduce the QTRam® portable transmission Raman system and demonstrate its capability for content uniformity analysis in solid dosage forms. It highlights key performance attributes, compliance features, and practical use cases in pharmaceutical environments.

Methodology and Instrumentation

The system employs STRaman® technology, leveraging a 785 nm laser for deep-sample interrogation. It integrates BWAnalyst® software compliant with 21 CFR Part 11 to facilitate step-by-step quantitative model development and reporting. Customizable sample holders accommodate various tablet and capsule dimensions. Power options include an AC adaptor (100–240 V, 50/60 Hz) and an optional battery pack for up to four hours of continuous operation.

Main Results and Discussion

Testing demonstrates that the QTRam system delivers precise quantitative analysis of active pharmaceutical ingredients, crystalline forms, and polymorphic content in seconds without any sample preparation. The large sampling volume reduces variability and enhances the detection of content inhomogeneities. Compliance with USP 905 confirms the method’s suitability for official content uniformity requirements.

Benefits and Practical Applications

• Rapid, non-destructive quantification in seconds
• Elimination of sample preparation and consumable costs
• Portable design enabling in-line, at-line, or laboratory use
• Comprehensive reporting with Part 11 compliance

Applications extend beyond content uniformity to counterfeit detection and formulation development, supporting quality assurance and process optimization.

Future Trends and Opportunities

Advancements in portable Raman spectroscopy are expected to integrate real-time process monitoring and machine learning-driven data analysis. Miniaturization of components and improved battery life will broaden in-field applications, while expanded spectral libraries will enhance counterfeit screening and complex formulation characterization.

Conclusion

The QTRam portable transmission Raman system provides an efficient, user-friendly solution for pharmaceutical content uniformity testing. Its high throughput, regulatory compliance, and flexibility make it a valuable tool across pharmaceutical research, quality control, and manufacturing.

Instrumentation Used

• Transmission Raman Spectrometer QTRam® (Model BWS475-785H-CU)
• 785 nm laser excitation
• BWAnalyst® software (21 CFR Part 11 compliant)
• Custom sample holders
• AC power adaptor and optional battery pack