Page 16 - Shimadzu’s Solutions for Impurities Analysis

FDA Regulations on Qualitative and Quantitative Analysis
Inorganic Impurities
of Inorganic Impurities
ICP Emission Spectrometer

˙ Trends in Inorganic Impurity Analysis Using an ICP Emission
Spectrometer

Inorganic impurities are one class of impurity in pharmaceutical ingredients. The ICP emission spectrometer is
pharmaceutical products listed in the ICH guidelines. effective for the analysis of trace inorganic impurities, such as
Inorganic impurities include metal from metal catalysts or control of aluminum in infusion solution required by FDA 21
manufacturing equipment used for the synthesis of the CFR Part 201.323.

FDA Regulations on
Genotoxic Impurities
˙ The ICP Emission Spectrometer
Features
Simultaneous analysis of many elements. Rapid qualitative
ɾ
and quantitative analysis. Allows reliable control to
eliminate metal impurities.
The high-sensitivity and wide range of linearity in the
ɾ
calibration curve make it easy to set the analytical
conditions.
ɾ
Phosphorus (P) and sulfur (S) can be measured in the same
ICPE-9000
way as other elements.
Multitype Inductively Coupled Plasma Emission Spectrometer
Residual Solvents
˙ The ICPE-9000 Multitype Inductively
FDA Regulations on
Coupled Emission Spectrometer Features
Incorporates an Echelle monochromator for high-speed
ɾ
measurements and high-resolution as well as a 1-inch CCD
detector.
Shimadzu's unique mini-torch light source halves argon gas
ɾ
consumption with no drop in sensitivity.
Various assistant functions allow anyone to rapidly perform
ɾ
accurate analysis. They also simplify the important selection
of the Echelle monochromator wavelength.

Workstation for ICP
˙ The ICPS-8100 Twin Sequential
Inorganic Impurities
FDA Regulations on
ICP Emission Spectrometer Features
The world-class, high-resolution monochromators permit
ɾ
accurate analysis of trace components in diverse matrix
components.
ɾ
Twin high-resolution monochromators offer both a wide
measurement range and high resolution.

ICPS-8100
Twin Sequential ICP Emission Spectrometer

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