Material Validation

Assure - Raw Material Screening

Impurities and adulterants are a potential
liability and are a source of production
delays when present in the manufacturing
of pharmaceutical APIs, drug products,
dietary supplements and chemical products. Increased reliance on a global supply
chain amplifies the need for QC screening
of materials prior to use in manufacturing
processes and at the final product. Effective screening where unknown adulterants
may occur requires both compound specificity and non-targeted methods. Assure
Raw Material Screening - (RMS) is a material validation system that provides a fully
automated solution for screening against
adulterants, degradants and impurities in
your raw materials. It also determines if
unknown materials are present during the
screening process.

Innovation with Integrity

Designed for use in GLP or non-GLP environments, Assure - RMS

provides a traceable record of sample analysis and results. Applications include pharmaceutical, dietary supplements, chemical production, and analytical reference standards.

Corporate Benefits

Reduce QC Material Validationtime for production

Identifies unknown material in the analysis

Reduce production costs and delays due to material waste from

bad batches

Enhance product safety and limit liability exposure

Available as a low cost renewable annual license or 15 year license

Method Benefits:

Validate materials with one measurement

Fully customizable

Designed for production by lab technicians

Automatedcalibration maintenance

Results and reports available in minutes

NMR Screening

The 1-page quality control report for a sample of bufferin that

passed QC test.

Reports
Assure-RMS provides a QC Pass/Fail
report in addition to an Expert Report that
identifies and quantifies known adulterants,
impurities and shows the presence of any
unknown materials.

System Suitability Test

Quantification

Excerpts from a report of a failed sample indicating the

presence of a known adulterant, phenetole.

Assure-RMS* includes:

Simultaneous targeted and non-targeted

detection of impurities and adulterants

Instrument quantification calibration is

maintained in full automation. Result
options include absolute molar/weight and
relative molar/weight of reference/total
intensity. Flexible Reporting allows result to
be customized for site specific needs.

Compound specific information based on

Bruker BioSpin

assure@bruker-biospin.com

Additional customization and GLP

certification is available through Bruker.

www.bruker.com/assure

*Patent Pending

NMR spectroscopy

Simultaneous qualitative and quantitative

assessment on 1H, 2H, 13C, 19F and 31P

A bsolute and relative quantification

Advanced Match algorithms for overlapped

spectra and complex spin systems

Advanced meta data handling

Basic chemometrics for variable material and

outlier detection
GLP/GMP compatible

40 sample general spectral base

Convenience features and lock-out modes

Bruker BioSpin 07/12 T124966

The fully automated System Suitability

Test validates instrument performance and
optimizes the system. Allows operation in
GLP/GMP settings.
Includes:
1
H Lineshape

1
H, 13C, 19F and 31P Sensitivity

Temperature
Calibration