Portable Raman System for Content and Blend Uniformity
The QTRam® is a portable Transmission Raman Spectrometer powered by our patent-pending, award-winning STRaman® technology that allows for rapid and nondestructive quantitative analysis ideal for content uniformity testing of finished products such as tablets and capsules.
Transmission Raman is an excellent means of rapid, nondestructive testing of content uniformity and of --blend-- uniformity, required tests for solid dosage forms. The portable QTRam can be used for at-line quantitation of tablet composition, reducing the time and associated production delays that come from needing to submit samples to the laboratory for in-process and final product testing. Calibrations can be developed for multicompetent testing from a single Raman spectrum. The QTRam measurement of the intact samples has the advantage that solid state properties of the sample, including polymorphic form and crystallinity, can be measured in addition to the chemical composition.
The QTRam can be easily operated using 21CFR Part 11 compliant software for quantitative analysis on the inbuilt tablet computer, while the portable form factor allows users to use it for at-line analysis or in the lab.
Content uniformity - ensure the dosage uniformity of the API in solid dosage finished product including tablets, capsules, and gels
Formulation development - support QbD initiatives in quantifying API and excipient concentrations in finished dosage forms
Counterfeit detection – calculate API quantity to ensure correct drug and correct dosage
Versatile STRaman® technology with high sensitivity and high-throughput for see-through, transmission, or conventional Raman Spectroscopy
Easy-to-use 21 CFR Part 11 compliant software for quick results and reporting
Portability for in-line, at-line, or laboratory analysis
Customizable sample holders to accommodate any sample dimension
Step by step, easy to follow quantitative modeling and method development
Rapid quantitative results in seconds
Quantitative sample composition, crystallinity and polymorphic form from single measurement over large sample volume
No sample preparation
No disposal cost
USP-recognized transmission Raman for content uniformity applications
B&W Tek offers comprehensive software packages that provide solutions for Raman application needs. Powerful calculations, easy data management, and user-friendly, easy-to-follow work flow are all at the tips of your fingers.
BWAnalyst™ is the touch-screen operated 21CFR part 11 software with a logical workflow for data acquisition, method building, routine analysis and reporting. Once the method is developed and validated, operators can quickly perform quantitative predictions, getting clear results in seconds, stored in a secure database. The software has configurable reports, with electronic signature and full audit trail.
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