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Residue detection method of sodium tetradecyl sulfate

A technology of sodium tetradecyl sulfate and a detection method, applied in measuring devices, material analysis through electromagnetic means, instruments, etc., can solve low sensitivity, long experiment preparation process and analysis time, response sensitivity of specific compounds or their functional groups Restrictions and other issues

Inactive Publication Date: 2017-12-15
SPH NO 1 BIOCHEM & PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The technical problem to be solved by this invention is to overcome the traditional HPLC, UV, GC and other methods that the residual detection of sodium tetradecyl sulfate adopts in the prior art. Due to the defects of relatively long process and analysis time and low sensitivity, a method for the detection of sodium tetradecyl sulfate residues that is completely different from the prior art is provided

Method used

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  • Residue detection method of sodium tetradecyl sulfate
  • Residue detection method of sodium tetradecyl sulfate
  • Residue detection method of sodium tetradecyl sulfate

Examples

Experimental program
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Effect test

Embodiment 1 14

[0080] Example 1 Sodium Tetradecyl Sulfate Injection Online Analysis of Wiping Residue in the Return Air Vent of the Weighing Room

[0081] The equipment surface detection standard is calculated and converted based on the 10ppm standard (safety factor 10). Due to the large system area, some conversion results exceed the detection range, so the safety factor 10 in the 10ppm wiping limit calculation formula is removed and converted to the original standard (10ppm ) for testing, and the wiping residue limits are shown in Table 8.

[0082] Table 8

[0083]

[0084] After the equipment is cleaned, use a TOC wipe cotton swab moistened with a solvent (such as water) to wipe the return air outlet of the weighing room. The wiping method is as follows: figure 1 As shown, the swab sampling area of ​​each sampling site is about 100cm2 , and then dissolve the cotton swab in 100mL water for injection, pipette 50mL into a clean TOC tube, fully wash the TOC instrument for 3 times, after ...

Embodiment 2 10

[0085] Example 2 On-line Analysis of Sodium Tetradecyl Sulfate Injection in the Rinsing Water Residue of Liquid Mixing Tank

[0086] The leaching residue limit calculated by the formula is shown in Table 9

[0087] Table 9

[0088]

[0089] After the last cleaning of the equipment (cleaning with water), take 100mL of the eluent into a clean container, pipette 50mL into a clean TOC tube, fully clean the TOC instrument for 3 times, and inject blank water, Shake the sample in the sample tube, mix the sample evenly, keep it clear and colorless, put the sample tube into the TOC analyzer in order for detection, so as to measure the TOC value of the sample and obtain the information of the residual amount of the sample. During the detection, a total of 4 times were detected, the first time was discarded, and acid and oxidant were added (the mass concentration was 400mg / L respectively). The deviation was 2.65ppb and the relative standard deviation was 4.90%.

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Abstract

The invention discloses a residue detection method of sodium tetradecyl sulfate. The method comprises the following steps: (1) preparation of a to-be-tested sample: sampling from cleaned equipment in contact with the sodium tetradecyl sulfate, so as to prepare the to-be-tested sample; (2) detection of the sample: detecting the to-be-tested sample obtained in step (1) with a TOC (total organic carbon) determination method. The detection method disclosed by the invention is fast and convenient, the analytical testing time and the waiting time of production are shortened, and the detection method also has the important significance in the maintenance aspect of a cleaning validation state.

Description

technical field [0001] The invention relates to the field of drug analysis and detection, in particular to a residual detection method of sodium tetradecyl sulfate, which can be used to determine the cleanliness of the preparation environment of sodium tetradecyl sulfate. Background technique [0002] Sodium tetradecyl sulfate was first described by Reiner in 1946 as a chemically synthesized surfactant. Widely used since 1950, but mostly as a cleaning agent. It is an alkali metal long-chain fatty acid with soap properties. Composed of sodium 1-isobutyl-4-ethylsulfate, pH 7.6 by addition of 2% benzyl alcohol and phosphate buffer. [0003] Sodium Tetradecyl Sulfate Injection is a non-viscous, clear solution with low surface tension, which is easily soluble in blood and distributed evenly after injection. Its mechanism of action is to break down the intercellular adhesive between endothelial cells, causing the cells to shed in patches. Disruption of the endothelium causes e...

Claims

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Application Information

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IPC IPC(8): G01N27/416
CPCG01N27/416
Inventor 赖伊丽罗晓娟宋志南黄臻辉
Owner SPH NO 1 BIOCHEM & PHARMA CO LTD
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