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Operating the Analyzer
January 2009 UDA2182 Universal Dual Analyzer Product Manual 33
5.8 Pharma Display
5.8.1 Overview
The Pharma Parameter is available when a Conductivity Input is enabled. Pharma
supports USP (United States Pharmacopoeia) and PhEur (Pharmacopoeia Europa)
standard procedure stages for determining Purified Water.
Selecting Pharma Type USP or PhEur (in Section 6.6 – Conductivity Input
Configuration) enables the Pharma monitor screen and adds it to the sequence of displays
accessed by each press of the Display button.
Also, configure Pharma PV High, Pharma PV Low, and Pharma Timer Minutes in this
section.
5.8.2 How it works
Pharmacopoeia Test Procedure
For Procedure steps in each stage, refer to UPS section <645> Test Procedure for
Purified Water and Water for Injection. The procedure for this determination involves a
series of three stages or tests. If the sample does not pass the Stage 1 conductivity
requirement, the State 2 test can be initiated. If the Stage 2 requirements are not met,
then the Stage 3 test can be initiated. If Stage 3 requirements are not met, the sample is
not Purified Water.
In Stage 1 the non-temperature-compensated conductivity reading is compared to the
value specified in the USP standard for a particular temperature. If the measured
conductivity is not greater than the table value, the water meets the requirements of the
test for conductivity and the Pharma test is complete. If the conductivity is higher than
the table value, then the user can manually proceed with Stage 2.
To complete stage 2, transfer a sufficient amount of water (100 mL or more) to a suitable
container, and stir the test specimen. While maintaining the temperature at 25° ± 1°,
begin vigorously agitating the test specimen and note the conductivity reading when the
change is less than 0.1 m S/cm per 5 minutes. If the conductivity is not greater than 2.1
m S/cm, the water meets the requirements of the test for conductivity. If the conductivity
is greater than 2.1 m S/cm, proceed with Stage 3.
Stage 3 must be completed within approximately 5 minutes of the conductivity
determination in stage 2. While maintaining the sample temperature at 25° ± 1°, add a
saturated potassium chloride solution to the same water sample (0.3 mL per 100 mL of
the test specimen), and measure the pH to the nearest 0.1 pH unit, as directed under pH
(791). From USP section <645>, determine the desired conductivity value for a pH value
between 5pH and 7pH. If the measured conductivity is not greater than the conductivity
from USP, section <625>, the water meets the requirements for stage 3 - purified water.
If either the measured conductivity is greater than this value or the pH is outside of the
range of 5.0 to 7.0, the water does not meet the requirements of stage 3 - purified water.
For Procedure steps in each stage, refer to UPS section <645> Test Procedure for
Purified Water and Water for Injection.