Specifying The Pharmacopeia; Pharmacopeia Options - GE Sievers 500 RL Operation And Maintenance Manual

Chapter 4: Basic Analyzer Operation

Specifying the Pharmacopeia

Because Pharmacopeia TOC and Conductivity Monographs diverge, the Analyzer allows you to specify which
Pharmacopeia Monograph is applicable to your environment. To specify the Monograph you want the Analyzer
to comply with, follow these steps:
1. Select the Maintenance tab.
2. Press the Advanced button.
3. Press the Advanced Setup button.
4. Press the Pharmacopeia button.
5. Press the one or more (in any combination) of the pharmacopeia options. (You can also use the Analyzer
without selecting a pharmacopeia option).

Pharmacopeia Options

You can select any combination or none of the following Pharmacopeia options:
• USP WFI/PW: The analyzer meets the test requirements for the United States Pharmacopeia (USP)
monographs; USP<643> Total Organic Carbon and USP<645> Conductivity. The water passes the
USP<643> TOC test if its measured TOC (r
sample passes the Stage 1 conductivity test if the measured conductivity is not greater than the
table value (at the first temperature in the chart that is not greater than the measured water
temperature).
• EP WFI/HPW: The analyzer meets the test requirements of the following European Pharmacopeia
(EP) monographs; EP (2.2.44) Total Organic Carbon in Water for Pharmaceutical Use and the
Conductivity Requirements of the EP monographs "Water for Injections" (WFI) and "Water, Highly
Purified" (HPW). The TOC test passes if the measured TOC of the pharmaceutical water sample is not
less than the lower of the Limit Response or 500 ppbC (per the requirements of the EP WFI and HPW
monographs). The Stage 1 conductivity test passes if the measured non-temperature compensated
conductivity value is not greater that the conductivity value in the table for WFI at the next lower
temperature (in the table), than the measured temperature of the water (Stage 1 test in the WFI or
HPW monographs).
• CP WFI: The analyzer meets the test requirements of the following Chinese Pharmacopeial (CP)
monographs; CP TOC Measurement in Pharmaceutical Water- Appendix VIII R for Water for Injection
and CP Conductivity- Appendix VIII S for Water for Injection. The TOC test passes if the sample of
WFI has a measured TOC value not greater than (r
Step 1 if the measured non-temperature compensated conductivity is not greater than the table
conductivity value at the next lower temperature value in the table that is not greater than the
measured temperature.
• IP WFI: The analyzer meets the test requirements of the India Pharmacopeia (IP) monographs for
Water for Injection: IP 2.4.30 Total Organic Carbon in Water and IP 2.4.9 Conductivity for Water for
Injections in Bulk. The TOC test is passed if the measured TOC of the sample (r
GE Analytical Instruments ©2010
) is not more than the Limit Response, (r
u
– r ) or 0.50 g/L. The conductivity test passes
s w
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– r ). The water
s w
) is not greater than (r
t s
DLM 74001-04 Rev. A