Assure Raw Material Screening
The Easy, Automated Solution for NMR-based Screening
Innovation with Integrity
NMR
The Easy-to-Use Solution for Simultaneous
Targeted and Non-Targeted Material Screening
Ideal for multiple applications, Assure-RMS (Raw Material Screening) brings easy,
automated screening to your lab. Automatically providing the answers you need when
identifying and quantifying material components, and classifying tested materials,
Assure-RMS simplifies the analysis and quality control of a wide variety of materials.
Whether the required analysis is for polymers, reference standards, APIs, synthetic
starting materials, botanical extracts or samples from a metabolic profiling run, this
customizable screening software will provide detailed summaries of the sample
composition and classification, all in complete automation.
Assure-RMS features Assure-System Suitability Test, a
fully integrated control tool that automatically validates and
optimizes system performance.
Within GMP environments, Assure - Raw Material Screening
provides a traceable record of sample analysis and results.
Applications extend beyond production environments and
include R&D settings.
User Benefits
nReduces
material screening time
material using in-house models
nIdentifies and quantifies components
nRed flags the presence of unknown material
nEnables enhanced product safety helping to limit exposure to liability
nLicensing options: available as a low cost renewable
annual license or 15 year license
nClassifies
Method Benefits
nFully
customizable: “Define your own steps”
your materials in a single measurement
nHighly compatible with both production and R&D facilities
nAutomated validation of system performance
nGenerate results and reports in minutes
nValidate
Simplifying Screening by NMR
Automatically-Generated, Customizable Reports
Assure-RMS makes life easy when it comes to reporting.
Automatically generating a range of report types, with
customizable selections and output formats you can report on
material identity, components identity, and quantification and
classification, including:
n
QC Pass/Fail report
n
Detailed Expert Report
n
Custom Reports
n
Exportable Excel Summary
Automated System Suitability Test
Removing all concerns regarding variable system performance or
walk-up results in a GLP/GMP environment, the Assure-System
Suitability Test automatically validates instrument performance
and maintains the system through shim maintenance. The
validation covers:
1
n
H Lineshape
1
n
H, 13C, 19F and 31P Sensitivity
n
Temperature Calibration
n
User Defined Experiments
Assure-SST is also available as a standalone product.
User-Defined Quantification
Quantification calibration of the instrument is maintained in
full automation, meaning the user only has to define their
quantification standards for any supported nuclei. Quantification
thresholds for standard pass/fail criteria can be set in accordance
with institutional standards. Result reporting options include,
reported to relative or total intensity:
n
Absolute molar or weight
n
Relative molar or weight
NMR Spectral Database
Component identification relies on finding a match with an NMR
Spectral Database (SBASE). With Assure-RMS software, both
Bruker-supplied or user-generated SBASES can be used to
screen many components simultaneously. Assure-RMS SBASE
Set 1 is supplied with a sbase of 40 common chemicals including
1D and 2D spectra at 300, 400 and 600 MHz. Additional AssureRMS SBASES are optionally available including:
n
Assure-RMS SBASE Set 2
n
Assure-Aloe SBASE
n
Assure-Heparin SBASE
Bruker Screening Solutions
Assure-RMS
methods
define
the
automation procedure for the acquisition,
analysis and processing of specific
materials. Methods are available from
Bruker or can be generated by the user.
Assure-RMS features intuitive tools
to assist the NMR user in generating
their own Assure-RMS methods for site
specific materials.
Available Solutions
Assure-Aloe
Based on the J. AOAC International
publication (2010), Assure-Aloe includes
a method and NMR spectral database for
the detection of at least 12 components
for quality control screening of Aloe vera.
Assure-Heparin
Based on the USP Monograph (2012),
Assure-Heparin includes a method and
NMR spectral database for quality control
screening of Heparin Sodium.
Poloxamer
Based on European Pharmacopeia 6.0,
the Assure-RMS method characterizes
poloxamers
and
reports
on
the
Oxypropylene:Oxyethylene ratio of these
common excipients and surfactants.
Cyclodextrin (Molar Substitution)
Based on European Pharmacopeia 5.0,
the Assure-RMS method characterizes
cyclodextrin by evaluating the number of
hydroxypropyl groups per anhydroglucose
unit.
Based on EU Directive ISO 21461, the
Assure-RMS method evaluates the
polyaromatic hydrocarbon (PAH) content.
Bruker BioSpin
assure@bruker-biospin.com
www.bruker.com/assure
© Bruker BioSpin 04/13 T143148
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