Method for detecting ethanol residue in recombinant hominine anti-TNF-a project cleaning validation sample
An ethanol and project technology, applied in the field of detection of ethanol residues in the cleaning verification samples of recombinant human anti-TNF-α projects, can solve the problems of no specificity, weak specificity, no good, etc., and achieve high precision and high precision. The effect of accuracy, good durability
Inactive Publication Date: 2019-03-29
苏州众合生物医药科技有限公司
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Benefits of technology
Gaschromatographic analysis methods are used for detecting alcohol impurities in biological samples such as blood or urine. These techniques have been developed over time with improved sensitivity but they still lack certain technical features like selectivity towards different compounds and ability to measure accurately levels without being affected by factors other than just water vapor pressure.
Problems solved by technology
This patented technical problem addressed in this patents relates to finding an effective way to prevent excessive amounts of alcohol from remaining within certain chemicals during purifying processes or storage conditions. Current methods require manual testing at different stages after production has been completed, making them difficult to implement on large scale due to their lacked precision.
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[0024] A method for detecting residues of ethanol in a clean sample of a recombinant human antibody TNF-α project, the method comprising: using gas chromatography, using a hydrogen flame ionization detector model 7890B, and a headspace sampler model 7697A Inject the sample, and use 6% cyanopropylphenyl-methyl polysiloxane as the stationary liquid; among them, the column length is 60m, the inner diameter is 0.53mm, and the film thickness is 3.00μm; the quantitative detection of recombinant human Ethanol residues in cleaning verification samples of source anti-TNF-α project;
[0025] The blank solution is water.
[0026] The cleaning validation sample is rinse water.
[0027] The temperature of the hydrogen flame ionization detector is 200°C-300°C, and the temperature of the injection port is 180°C-250°C.
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Abstract
The invention discloses a method for detecting ethanol residue in a recombinant hominine anti-TNF-a project cleaning validation sample. The ethanol residue in the recombinant hominine anti-TNF-a project cleaning validation sample is determined by adopting gas chromatographic method (GC), and the defect that the TOC total organic carbon detection method has no specificity is solved, and the ethanolresidue detection can be quantitatively accomplished. The method disclosed by the invention bas good durability and specificity, relatively high precision and accuracy; and the experimental conditioncan change in the durability experimental range.
Description
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