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Appendix VIII R Total Organic Carbon Determination in Pharmaceutical Water This method is used to check the total amount of organic carbon in pharmaceutical water to indirectly control the organic content of water. Total organic carbon inspection is also used for process control of water systems, such as monitoring the efficiency of unit operations such as purification and water delivery.
Organic matter in pharmaceutical water typically comes from water sources, water systems (including purification, storage, and delivery systems) and the growth of bacteria in water systems.
Usually, sucrose is used as an easily oxidizable organic substance, and 1,4-p-benzoquinone is used as a hard-to-oxidize organic substance. The respective standard solutions are prepared according to the regulations, and the corresponding response values ​​are respectively determined on the total organic carbon analyzer to examine the technology used. Oxidation capacity and system suitability of the instrument.
General requirements for the instrument There are several methods for determining total organic carbon. For these techniques, the total organic carbon determination for water can be used as long as the following conditions are met:
1. The total organic carbon measurement technology should be able to distinguish between inorganic carbon (carbon dioxide produced by decomposition of carbon dioxide and bicarbonate dissolved in water) and organic carbon (carbon dioxide produced by oxidation of organic matter), and can exclude inorganic carbon from measuring organic carbon. interference.
2. The requirements of the system suitability test should be met.
3, should have sufficient detection sensitivity (zui low detection limit is equal to or less than the carbon content per liter
0.05 mg/L).
On-line monitoring or off-line laboratory measurements of the water system using a calibrated instrument. On-line monitoring facilitates real-time measurement and real-time process control of water systems; off-line measurements can cause many problems, such as contamination by sampling, sampling containers, and uncontrolled environmental factors such as organic vapors.
Since the production of water is carried out in batches or continuously, it is determined by the conditions and specific conditions of water production when selecting whether to use off-line or on-line measurements.
The total organic carbon inspection water should be less than 0.10mg per liter of total organic carbon, and the conductivity is less than 1.0.
High purity water at μS/cm (25 ° C). The total organic carbon test water used and the preparation reference solution and the system suitability test solution water should be the same container of water.
Preparation of the reference solution The sucrose reference solution is prepared by drying at 105 ° C to a constant weight of sucrose reference substance, unless otherwise specified.
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The amount is accurately weighed, and the total organic carbon is dissolved in water and diluted to prepare a solution containing about 1.20 mg per liter (0.50 mg per liter of carbon).
1,4-p-benzoquinone reference solution, unless otherwise specified, take appropriate amount of 1,4-p-benzoquinone reference substance, accurately weighed, add total organic carbon test water dissolved and diluted to make 0.75mg per liter Solution (carbon per liter)
0.50 mg).
Off-line measurement of the test solution Due to the collection and delivery of the water sample to the test device, the water sample is likely to be contaminated, and the contamination of organic matter and the absorption of carbon dioxide will affect the authenticity of the measurement results. Therefore, all aspects of the measurement should be very cautious. A closed container should be used for sampling, and the top space of the container should be as small as possible after sampling.
And should be tested in time. The glassware used must be cleaned of organic residues and rinsed with total organic carbon.
On-line measurement connects the total organic carbon on-line detection device to the water production system. Both the water intake and the measurement system must be thoroughly cleaned.
The system suitability test takes the total organic carbon test water, the sucrose reference solution and the 1,4-p-benzoquinone reference solution respectively to record the total organic carbon response value of the instrument. The response efficiency expressed as a percentage should be 85% to 115% as calculated by the following formula.
100[(rss-rw)/(rs-rw)]
Where rw is the blank response value of the total organic carbon test water;
Rs is the response value of the sucrose reference solution;
Rss is the response of the 1,4-p-benzoquinone reference solution.
The method of determination is to take the appropriate amount of water for the test drug, and determine according to the method specified by the instrument. Record the response of the instrument
rU, unless otherwise specified, the response value of the test pharmaceutical water should not be greater than rs-rw (0.50mg / L).
This method can be used simultaneously with online or offline instrumentation that has been previously calibrated and tested for system suitability. The quality of this water, measured online or offline, is closely related to the location of the water sample in the water system.
It should be noted that the location of the water sample must accurately reflect the quality of the pharmaceutical water.

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