Page 14 - Shimadzu’s Solutions for Impurities Analysis

FDA Regulations on Qualitative and Quantitative Analysis
Residual Solvents
of Residual Solvents
Headspace GC

˙ Residual Solvent Analysis in Pharmaceuticals Using the
GC-2010 Plus with a Headspace Sampler

ICH decisions are leading to a standardization of the Japanese drug application (NDA) or abbreviated new drug application
Pharmacopoeia, U.S. Pharmacopoeia, and European (ANDA).
Instead of testing the final pharmaceuticals, testing can be
Pharmacopoeia analytical methods. For example, the USP ɾ
<467> Residual Solvents method for analysis of residual performed on the pharmaceutical ingredients and
solvents in pharmaceutical products in the U.S. pharmaceutical additives.
Apart from analysis methods listed in the USP <467>
Pharmacopoeia (USP 32) has changed from the conventional ɾ
Organic Volatile Impurities method to a Residual Solvents method, it is acceptable to use another analytical procedure
FDA Regulations on
Genotoxic Impurities
method based on the analysis method in the European correctly
Pharmacopoeia. The FDA has issued the following listed and revised according to the cGMP (standards for
recommendations in the draft guidance, "Residual Solvents in manufacturing control and quality control of
Drug Products Marketed in the United States." pharmaceuticals) requirements.
ɾ The Shimadzu GC-2010 Plus meets these requirements and
To sell products listed for the official analytical method in
the United States they must meet the requirements of the supports the analysis of residual solvents.
USP <467> Residual Solvents method, regardless of any new

˙ The GC-2010 Plus with a Headspace Sampler Features

ɾ and flow switching; Advanced Flow Technologies realize shorter
Shimadzu's GC-2010 Plus is the next-generation gas
Residual Solvents
FDA Regulations on
chromatograph offering highly reliable trace-level and analysis cycles and improve productivity.
high-speed analysis as well as excellent operability. ɾ
Easy-to-use features save time reduce total analysis costs.
Best-in-class(*) high-sensitivity detectors (FPD and FID) ensure
ɾ
high-precision analytical results. (*) Based on our survey as of April 2009
ɾ
Shimadzu’s unique technologies for ultimate gas flow control

FDA Regulations on
Inorganic Impurities
GC-2010 Plus
Advanced Flow Technology Gas Chromatograph

Operation Screen Identification/Quantitation Screen
Support from Shimadzu
LabSolution
Workstation for GC

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