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TOC Application - TOC-L - USP-Specified TOC System Suitability Test by TOC-LCPH

The document describes a test of a Total Organic Carbon (TOC) analyzer to ensure it meets specifications from the United States Pharmacopeia (USP). The analyzer passed tests for system suitability and was able to accurately detect and measure TOC concentrations below 0.05 mg/L, as required.

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Ramon Trinidad De la O
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68 views

TOC Application - TOC-L - USP-Specified TOC System Suitability Test by TOC-LCPH

The document describes a test of a Total Organic Carbon (TOC) analyzer to ensure it meets specifications from the United States Pharmacopeia (USP). The analyzer passed tests for system suitability and was able to accurately detect and measure TOC concentrations below 0.05 mg/L, as required.

Uploaded by

Ramon Trinidad De la O
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
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LAAN-A-TC-E020

Application
Total Organic Carbon Analysis

News USP-Specified TOC System Suitability Test by TOC-LCPH

No. O44
The United States Pharmacopeia (USP) specifies the use n TOC System Suitability Test Data by USP Method
of Total Organic Carbon (TOC) for management of The TOC system suitability test was conducted using
organic impurities in purified water (PW) and water for the Shimadzu TOC-LCPH combustion catalytic oxidation
injection (WFI). According to the USP, the TOC analyzer type analyzer by the procedure outlined in Table 1. The
to be used for these analyses must satisfy the TOC instrument was calibrated beforehand using aqueous
system suitability testing requirement, and must be solutions of potassium hydrogen phthalate with carbon
capable of detecting TOC at concentrations below concentrations of 0 and 0.5 mgC/L, respectively. The
0.05 mg/L. TOC system suitability test data are shown in Fig. 1.
Here, using the Shimadzu TOC-L CPH combustion According to the USP, the detection rate is to be
catalytic oxidation type analyzer, we introduce examples evaluated using the analyzer response values, but here,
of TOC system suitability testing and measurement of the measured concentrations were used instead.
TOC at a concentration below 0.05 mg/L. The result indicated a 100.1 % detection rate with
re s p e c t t o t h e s y s t e m s u i t a b i l i t y t e s t s o l u t i o n
(1,4-benzoquinone aqueous solution), thereby satisfying
n TOC System Suitability Test Specified in USP the system suitability test requirement. (Table 2)
The TOC system suitability test indicated in the USP
specifies the use of two types of USP reference
standards (sucrose and 1,4-benzoquinone). Sucrose is Measurement Conditions
used as a test solution standard, and 1,4-benzoquinone Analyzer : Shimadzu TOC-LCPH Combustion Catalytic
is used as the system suitability test solution. Oxidation Type Analyzer
In addition, calibration of the TOC analyzer is specified Catalyst : High-sensitivity catalyst
Injection Volume : 816 µL
to be conducted using a method that is suitable for Measurement Item : TOC (= NPOC: TOC by acidification/sparging)
that instrument. The test procedure is shown in Table 1. Calibration Curve : 2-point calibration curve using 0 – 0.5 mgC/L
potassium hydrogen phthalate aqueous solution

Table 1 TOC System Suitability Test Procedure Specified in USP

TOC System Suitability Test Procedure


(1) Measure the TOC in distilled water (distilled water used for
preparing test solution). This value is indicated as rw.
(2) Measure the TOC in the sucrose standard solution (0.50 mg/L
carbon concentration). This value is indicated as rs.
(3) Measure the TOC by the system suitability test
(1,4-benzoquinone solution with 0.50 mg/L carbon
concentration). This value is indicated as rss.
(4) The system suitability test requirement is satisfied if:
detection rate = 100 (rss - rw) / (rs - rw) is 85 % - 115 %

Pure Water Sucrose Standard Solution System Suitability Test Solution


(1,4-benzoquinone solution)
Fig. 1 TOC System Suitability Test Data
Application No. O44
News

Table 2 Results of TOC System Suitability Test Table 3 Measurement Data for TOC Concentrations Below
0.05 mg/L (50 µg/L)
(1) Distilled water TOC value rw= 0.0205 mg/L
Coefficient of
(2) Sucrose standard solution TOC value rs = 0.5173 mg/L Sample Name TOC Value [mgC/L]
Variation (CV) [%]
(3) System suitability test solution (1,4-benzoquinone aqueous Potassium hydrogen
solution) TOC value rss = 0.5176 mg/L phthalate aqueous 0.047 2.66
solution
(4) System suitability test solution detection rate
= 100 (rss - rw) / (rs - rw)
= 100 (0.5176 - 0.0205) / (0.5173 - 0.0205)
= 100.1 %

n TOC Measurement Below 0.05 mg/L


The USP specifies that TOC analyzers to be used must
be able to detect TOC at a concentration below
0.05 mg/L.
To verify this, we measured a potassium hydrogen
phthalate aqueous solution with a TOC concentration
of 0.025 mgC/L. The results are shown in Fig. 2 and
Table 3. Because the distilled water used to prepare the
sample contained TOC components as impurities, the
measurement resulted in a higher concentration of
0.047 mgC/L, with a resulting coefficient of variation
(CV) of 2.66 %. Since the coefficient was within 10 %,
a CV value commonly associated with a concentration
close to the lower limit of quantitation, the Shimadzu
TOC-LCPH combustion catalytic oxidation type analyzer
c l e a r l y s a t i s f i e d t h e U S P re q u i re m e n t f o r T O C
measurement of concentrations below 0.05 mg/L.

Fig. 2 Measurement Data for TOC Concentrations Below


0.05 mg/L (50 µg/L)

Measurement Conditions

Analyzer : Shimadzu TOC-L CPH Combustion Catalytic


Oxidation Type Analyzer
Catalyst : High-sensitivity catalyst
Injection Volume : 816 µL
Measurement Item : TOC (= NPOC: TOC by acidification/sparging)
Calibration Curve : 2-point calibration curve using 0 – 0.5  mgC/L
potassium hydrogen phthalate aqueous solution
Sample : 0.025  mgC/L potassium hydrogen phthalate
aqueous solution

First Edition: Mar, 2013

For Research Use Only. Not for use in diagnostic procedures.


The content of this publication shall not be reproduced, altered or sold for any commercial purpose without the written approval of Shimadzu.
The information contained herein is provided to you "as is" without warranty of any kind including without limitation warranties as to its
accuracy or completeness. Shimadzu does not assume any responsibility or liability for any damage, whether direct or indirect, relating to the
use of this publication. This publication is based upon the information available to Shimadzu on or before the date of publication, and subject
to change without notice.
www.shimadzu.com/an/ © Shimadzu Corporation, 2013

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