QTRam Portable Raman System for Content Uniformity

Importance of the Topic

The uniform distribution of active pharmaceutical ingredients (API) in solid dosage forms is critical for ensuring efficacy, safety and regulatory compliance. Rapid, non-destructive analysis techniques that can probe the whole sample volume streamline quality control and development workflows, reduce waste and support real-time release strategies.

Objectives and Overview of the Article

This document presents the QTRam® Portable Raman System, a transmission Raman spectrometer designed for content uniformity testing, formulation development and counterfeit identification. The focus is on describing its key specifications, operational features and the advantages it offers for pharmaceutical applications.

Methodology and Instrumentation Used

The QTRam® employs STRaman® technology, combining a 785 nm laser source with a transmission geometry to interrogate large sample volumes. Measurements are processed using BWAnalyst® software compliant with 21 CFR Part 11. The system can run on AC power or an optional battery lasting up to four hours, and accommodates varied sample sizes through customizable holders.

Main Results and Discussion

The system delivers quantitative results within seconds, capturing composition, crystallinity and polymorphic form from a single measurement without any sample preparation. Key performance attributes include:

• High sensitivity and throughput due to advanced transmission Raman optics
• Robust quantitative modeling workflows embedded in user-friendly software
• Portable design enabling in-line, at-line or laboratory analysis

Validation against USP 905 confirms suitability for content uniformity testing in compliance with pharmacopeial requirements.

Benefits and Practical Applications of the Method

The QTRam® system offers:

• Rapid, reproducible content uniformity assessment in seconds
• Elimination of sample preparation, consumables and associated waste
• Cost savings from non-destructive testing and zero disposal costs
• Versatility across formulation development, routine quality control and anti-counterfeiting

These features support GMP environments and facilitate real-time release testing strategies.

Future Trends and Opportunities

Advances in compact laser sources and detector technologies will further enhance sensitivity and reduce instrument footprint. Integration with automated sampling systems and process analytical technology (PAT) platforms is expected to enable continuous monitoring of manufacturing lines. Machine learning models for spectral analysis may expand applicability to complex formulations and new dosage forms.

Conclusion

The QTRam® Portable Raman System provides a robust, non-destructive solution for content uniformity and related pharmaceutical analyses. Its combination of transmission Raman spectroscopy, compliant software and portability meets industry demands for rapid, reliable testing and aligns with regulatory expectations.

Reference

• United States Pharmacopeia Chapter 905: Uniformity of Dosage Units.
• B&W Tek QTRam® Documentation, Doc Rev: 400000244-E, 12/17/2019.