QTRam®

Portable Raman Spectrometer for Content Uniformity The QTRam®, powered by B&W Tek’s STRaman®

technology, is a portable transmission Raman spectrometer that allows for rapid and nondestructive quantitative analysis ideal content uniformity testing of finished products such as tablets and capsules. The unit can be easily operated using 21 CFR Part 11 compliant Raman Solution

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.

Applications:

Content uniformity - ensure the dosage uniformity of the API in solid-dosage finished products including tablets, capsules, and gels as required by the USP <905> 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 Features:

Benefits:

• STRaman technology with high-throughput for

• Quantitative sample composition, transmission Raman spectroscopy over large sample crystallinity and polymorphic form volumes.

from single measurement

• Easy-to-use 21 CFR Part 11 compliant software for

• Rapid quantitative results for one or quick results and reporting

more ingredients in seconds

• Portability for at-line or laboratory analysis

• No sample preparation

• Customizable sample holders to accommodate most • No consumables sample dimensions

• No disposal cost

• Step-by-step, easy-to-follow quantitative modeling and method development

• USP-recognized transmission Raman for content uniformity testing





Specifications:

Model

BWS475-785H-CU

Laser Source

785 nm, full power >420 mW at sample with software-adjustable power Software

21 CFR Pt. 11 Compliant BWAnalyst®

System Configuration

Transmission Raman

Power Adaptor

Input: 100-240V AC 50/60 Hz, Output: 12VAC @6.6 Amps Physical

Main Unit

QT-Sampler®

Dimensions

15.7 in x 10.2 in x 9.8 in

13.01 in x 6.68 in x 6.97 in

(40 cm x 26 cm x 25 cm)

(33 cm x 17 cm x 18 cm)

Weight

~19.5 lbs (~8.8 kg)

~17.81 lbs (~8.5 kg)

Operating Temperature

0 ˚C – 35 ˚C

Humidity

10% - 85%, non-condensing

Software:

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 workflows 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 that are stored in a secure database. The software has configurable reports, with electronic signatures and a full audit trail.

BWIQ® multivariate analysis software is used to develop quantitative models used in BWAnalyst for predictions.

System Includes:

• QT-Sampler® and two standard sample holders

• Laser safety goggles

• BWAnalyst® touchscreen software

• BWSpec® operating software for exploratory work

• BWIQ® chemometric software

19 Shea Way, Newark, DE 19713, USA • Tel: +1 (302) 368-7824 • Web: www.bwtek.com For more technical information, visit www.bwtek.com/learning-lab Copyright 2018 B&W Tek , LLC· Doc-Rev: 280001286-E (2020/03/31)