Page 6 - Shimadzu’s Solutions for Impurities Analysis

FDA Regulations on Structural Analysis of Ultra-trace
Genotoxic Impurities
Impurities
LCMS-IT-TOF ®

˙ The Structural Analysis of Ultra-trace Organic Impurities
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Using the LCMS-IT-TOF Mass Spectrometer
The FDA draft guidance, "Genotoxic and Carcinogenic drug dose at levels approximately 150 times lower than
Impurities in Drug Substances and Products: Recommended prescribed in the ICH guidelines.
Approaches," was issued to cover the verification of the NMR is a typical method for the structural analysis of organic
genotoxicity and carcinogenicity of ultra-trace impurities in compounds. However, due to the need to analyze mixtures
new pharmaceuticals, investigational new drugs, and generic and the demand for sensitivity, LCMS-IT-TOF , which offers
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pharmaceuticals by structural analysis. This demands precise mass measurements and MS , is an effective method
structural analysis of ultra-trace impurities in a 200 mg daily for the structural analysis of ultra-trace impurities.
FDA Regulations on
Genotoxic Impurities
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˙ The LCMS-IT-TOF Realizes High Precision Mass ɹ
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Measurement in High Efficiency MS Measurement
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LCMS-IT-TOF , a mass spectrometer combining QIT (ion trap)
ɾ ® automated extraction of a structurally-relevant peak using MS 230nm,4nm (1.00)
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and TOF (time-of-flight) technologies, provides MS capability spectral similarity. Composition Prediction Software (Formula
by the QIT and precise, high-resolution mass measurement Predictor) is capable of formula prediction using mass accuracy
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capabilities by TOF. Precise mass measurement in MS , which is as well as by combining isotopic pattern scoring, chemical rule
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not possible using a typical LC/MS/MS, is now a reality. and MS filtering.
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When analyzing an ultra-trace impurity and it cannot be
Shimadzu offers a versatile software solution to support
Residual Solvents
workflows covering detection of ultra-trace impurities, determined whether the samples will be detected as positive or
FDA Regulations on
composition prediction and structural prediction. MetID negative ions, the high-speed, stable ion polarity switching
Solution Metabolite Structural Analysis Software is capable of mode ensures mass spectral information will be obtained.

Prominence Series and LCMS-IT-TOF ®
High-Performance Liquid Chromatograph Mass Spectrometer
Inorganic Impurities
FDA Regulations on

LCMSsolution Ver. 3 Series MetID Solution Formula Predictor
Support from Shimadzu
LCMS-IT-TOF Work Station Metabolite Structural Analysis for LCMS-IT-TOF ®
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Software for LCMS-IT-TOF ®

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