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TOC Total Organic Carbon Testing Requirements for the Pharmaceutical Industry

by:BOQU     2023-04-11
TOC total organic carbon detection requirements in the pharmaceutical industry Working principle This instrument adopts the principle of ultraviolet oxidation to oxidize the organic matter in the sample to carbon dioxide. The carbon dioxide test adopts the direct conductivity method. The total organic carbon content is determined by the difference between the total carbon content of the sample and the total inorganic carbon content of the unreacted sample, that is: total organic carbon (TOC) = total carbon (TC) - total inorganic carbon (TIC). Product Features The instrument adopts a portable design, which is easy to use and easy to move to the sampling point. Embedded system, touch screen design, easy to operate in pure Chinese. It is designed and tested for the total organic carbon content of water (TOC content below 1000ppb). Equipped with a large amount of storage space, it can store a large amount of test data. Chinese printing, output test parameters and test results. No gas or reagents are required during use, storage and replacement, and there are no moving parts, reducing repair and maintenance costs. When the test sample concentration exceeds the specified limit, the instrument can automatically alarm and output a control signal. According to the test scheme stipulated in GJ 'Chinese Pharmacopoeia'? CP2015, IQ/OQ/PQ services can be provided. The test conditions of the repeatability test analyzer are as follows: The appearance of the performance analyzer should be smooth and clean, easy to clean, and the signs should be clearly written. If there are dangerous parts, the upper limit alarm test should be carried out. The provisions and preparation methods in Appendix A are required; where in the formula: the test standard deviation of S measurement mg/L; n the number of measurements; xi range standard solution standard indication value mg/L; /L; RSD The relative standard deviation is the repeatability. This standard is applicable to the total organic carbon analyzer for detecting the concentration of organic carbon in purified water, water for injection and sterilized water for injection. The relative humidity is ℃±℃, the atmospheric pressure is kPakPa, the AC power supply voltage is V±V, and the AC power supply frequency is Hz±Hz. The continuity of the protective connection circuit of the electrical system should meet the requirements in GB-The withstand voltage of the electrical system should meet the requirements in GB- The system suitability test of the provisions of the electrical safety system suitability GB/T random number and its application in the product quality sampling inspection; take the full-scale sucrose standard solution and standard solution preparation water to measure when the sample for the test sample is determined by the standard Change the water for solution preparation to the range sucrose standard solution, start timing until the detected value reaches the standard concentration of the range standard solution, and stop timing. The time required is the response time. Response time. Response time Test environment suitability requirements Appearance test Analyzer total organic carbon measurement repeatability It should be superior to the general technical conditions for packaging of GB/T electromechanical products. .
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