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204 TOC According EP2244 12K

The document outlines the procedure for Total Organic Carbon (TOC) determination according to European Pharmacopoeia (EP) 2.2.44, emphasizing the importance of system suitability tests using standard and control solutions. It details the requirements for blank water and the acceptable recovery range for the benzoquinone standard. Additionally, it mentions the use of TOC-Control L software to facilitate the implementation of these tests and the calculation of results.

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Mariam Hamed
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23 views2 pages

204 TOC According EP2244 12K

The document outlines the procedure for Total Organic Carbon (TOC) determination according to European Pharmacopoeia (EP) 2.2.44, emphasizing the importance of system suitability tests using standard and control solutions. It details the requirements for blank water and the acceptable recovery range for the benzoquinone standard. Additionally, it mentions the use of TOC-Control L software to facilitate the implementation of these tests and the calculation of results.

Uploaded by

Mariam Hamed
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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Sum parameter – Total Organic Carbon

TOC-Determination according to
EP 2.2.44
SCA-130-204

Since the USP (United States ■ System suitability test


Pharmacopoeia) regulations for the For the system suitability test, a standard
determination of Aqua Purificata and Aqua ad sucrose solution with a carbon content of 0.5
injectabilia has been implemented into the mg/L is prepared. A control solution of 1,4-
European Pharmacopoeia (EP), TOC benzoquinone with the same carbon content
analysis has become increasingly established was subsequently prepared. The blank water
in quality control. Users who test the TOC (ultra-pure water) used for this purpose may
content in pharmaceutical water must not exceed a TOC content of 0.1 mg/L. For
regularly test their TOC system using a the system suitability test, all solutions
system suitability test according to the including the blank water are subsequently
method described in the EP 2.2.44 measured and the resulting signals are
guidelines. recorded.

Blank water: rw
Standard solution (sucrose): rs
Control solution (benzoquinone): rss

The peak area of the blank water is


subtracted from the peak areas of both
standard solutions. The recovery of the
benzoquinone standard is then calculated
with respect to the sucrose standard.
rss  rw
 100
■ European Pharmacopeia Recovery in %: rs  rw
The EP 2.2.44 guidelines do not prescribe
any particular oxidation technique for TOC Results between 85 - 115% are acceptable.
determination. The TOC systems, however, The ultrapure water sample corresponds to
must be able to differentiate between the guidelines when its response signal (ru)
inorganic and organic carbon. This can be does not exceed rs - rw.
carried out either via removal of the inorganic
carbon (NPOC method), or via a separate
determination (difference
method). The limit of detection for TOC
should be at least 0.05 mg /L. The
applicability of the method must be
determined via a system suitability test.
SCA-130-204

■ TOC-Control L software The determination of benzoquinone is set in


The TOC-Control L software simplifies the the sample / method properties wizard.
implementation of the system suitability tests
using integrated templates for the creation of
calibration curves and the measurement of
the control sample.

Fig. Calibration curve wizard

The following figure shows an example of an


EP calibration curve (2 points, blank and 500
µg/L).
Fig. Benzochinone-Determination

After measuring the benzoquinone sample,


the software automatically calculates the
recovery according to EP 2.2.44, whereby the
peak area values for the blank sample and
the sucrose sample are obtained from the
calibration curve. The result is listed under
the column ‘Notes’ in the sample table
(Figure below).

Fig. Calibration Curve

Fig. Result of system suitability test in sample table

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