Page 10 - Shimadzu’s Solutions for Impurities Analysis

FDA Regulations on
Quantitation of Ultra-trace Impurities
Genotoxic Impurities
LCMS-2020

˙ Quantitation of Ultra-trace Organic Impurities Using an
Ultra-Fast LC/MS System with Prominence UFLC and LCMS-2020

Organic impurities in pharmaceutical products may derive during the pharmaceutical production process, and stability
from the ingredients, substances generated during testing, "Genotoxic and Carcinogenic Impurities in Drug
formulation, or substances decomposed during storage. A Substances and Products: Recommended Approaches."
mass spectrometer offering general detection and specific The three "UF" (Ultra-Fast) features of the Shimadzu
analysis is effective for the comprehensive and efficient Ultra-Fast LC/MS system with Prominence UFLC and
quantitation of ultra-trace impurities specified in the FDA LCMS-2020 provide ultra-fast analysis of ultra-trace
draft guidance on testing pharmaceutical ingredients, testing impurities.
FDA Regulations on
Genotoxic Impurities

˙ The Prominence UFLC and LCMS-2020 Realize Ultra-Fast
Analysis

Ultra-Fast LC/MS system with Prominence UFLC and LCMS-2020
ɾ
ensures faster and more accurate HPLC analysis and improves
productivity in your laboratories.
ESI probe
The three “UF” technologies: “UFswitching” for fast polarity
ɾ
switching, “UFscanning” for fast scanning and “UFsensitivity”
for unsurpassed sensitivity and reproducibility utilizing newly
designed ion optics ensure the capture of sharp peaks
Residual Solvents
FDA Regulations on
generated by ultra-fast LC.
ɾ
The detection of ultra-trace impurities over a wide
concentration range demands not only high sensitivity but also
a wide dynamic range. The newly developed LCMS-2020 ion
®
optical system, Qarray , achieves superior sensitivity,
reproducibility, and linearity. Corona needle
An extensive range of ionization methods is required to handle
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diverse impurities having different characteristics such as
DUIS-2020 Concept Diagram
oil-soluble and water-soluble compounds. The DUIS-2020 Dual
Ion Source is one of the LCMS-2020's ionization methods. It
combines ESI and APCI methods, ensuring that even impurities
with significantly different polarities are not missed.
FDA Regulations on
Inorganic Impurities

LCMS-2020 LabSolutions LCMS Ver. 5
Ultra Fast Liquid Chromatograph Mass Spectrometer LCMS-2020 Workstation

Support from Shimadzu

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