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What is the theoretical background of conductometry?

What is the theoretical background of conductometry?

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2. BASICS OF CONDUCTOMETRY2.2. Conductivity measurement in water forpharmaceutical use according to USP andPharm. Europe (EP)There are special requirements for <strong>the</strong> conductivitymeasurement in water for pharmaceutical use («waterfor injections») according to USP 645, EP 2.2.38resp. <strong>the</strong> latest EP -4.8-07/2004:0169. Besides a prec<strong>is</strong>ionconductometer whose temperature compensationcan be d<strong>is</strong>abled, a conductivity measuringcell and a conductivity standard are to be used thatallow to determine <strong>the</strong> cell constant with a maximummeasuring error <strong>of</strong> 2%. To prevent <strong>the</strong> uptake <strong>of</strong> carbondioxide, <strong>the</strong> measurement should be carried underexclusion <strong>of</strong> air and/or in a flow cell. The samplefulfills <strong>the</strong> specification if one <strong>of</strong> <strong>the</strong> following threeconditions <strong>is</strong> met:Stage 1:The sample <strong>is</strong> measured directly without fur<strong>the</strong>r pretreatmentand without temperature compensation. If<strong>the</strong> water fulfills <strong>the</strong> specification indicated in table17, <strong>the</strong> test <strong>is</strong> considered as passed.Stage 2:If <strong>the</strong> conditions are not fulfilled by stage 1, continueas follows: The conductivity <strong>of</strong> at least 100 mL sample<strong>is</strong> measured under strong agitation at 25 °C ±1 °C assoon as <strong>the</strong> drift caused by <strong>the</strong> uptake <strong>of</strong> carbondioxide <strong>is</strong> smaller than 0.1 μS/cm per five minutes. If<strong>the</strong> measured value <strong>is</strong> smaller than 2.1 μS/cm, <strong>the</strong> test<strong>is</strong> considered as passed.Stage 3:However, if <strong>the</strong> sample does not fulfill <strong>the</strong> specification<strong>of</strong> stage 2, a sample <strong>of</strong> exactly 100 mL <strong>is</strong> mixedwith 0.3 mL saturated KCl solution. Then <strong>the</strong> pH value<strong>of</strong> th<strong>is</strong> solution <strong>is</strong> measured exactly to 0.1 pHunits. Only if <strong>the</strong> conductivity fulfills <strong>the</strong> conditionsspecified in table 18 <strong>the</strong> test <strong>is</strong> considered as passed.O<strong>the</strong>rw<strong>is</strong>e <strong>the</strong> water cannot be used for pharmaceuticalpurposes.Table 17: First step <strong>of</strong> <strong>the</strong> conductivity measurement according to USP 645 and EP -4.8-07/2004:0169Temperature Conductivity not Temperature Conductivity notlarger than (μS/cm)larger than (μS/cm)0 0.6 55 2.15 0.8 60 2.210 0.9 65 2.415 1.0 70 2.520 1.1 75 2.725 1.3 80 2.730 1.4 85 2.735 1.5 90 2.740 1.7 95 2.945 1.8 100 3.150 1.9Table 18: pH and conductivity criteria for stage 3pH Conductivity not pH Conductivity notlarger than (μS/cm)larger than (μS/cm)5.0 4.7 6.1 2.45.1 4.1 6.2 2.55.2 3.6 6.3 2.45.3 3.3 6.4 2.35.4 3.0 6.5 2.25.5 2.8 6.6 2.15.6 2.6 6.7 2.65.7 2.5 6.8 3.15.8 2.4 6.9 3.85.9 2.4 7.0 4.66.0 2.492

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