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BDDE residual quantity detection method

A detection method and residue technology, applied in the field of BDDE residue detection, can solve the problems of poor separation effect of BDDE, harm, carcinogenicity, etc., and achieve the effects of good stability, simple operation and accurate results.

Active Publication Date: 2016-05-04
ZHEJIANG JINGJIA MEDICAL TECH CO LTD
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  • Description
  • Claims
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Problems solved by technology

Chloroform reacts with oxygen in the air when it encounters light, and gradually decomposes to generate highly toxic phosgene and hydrogen chloride, which has the possibility of carcinogenicity and is quite harmful to experimenters.
The experimental results show that the separation effect of BDDE is not good

Method used

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Embodiment Construction

[0019] The present invention can be further clearly understood through the specific examples of the present invention given below, but they are not intended to limit the present invention.

[0020] The present invention provides a kind of analysis method that can measure BDDE residual amount in the preparation:

[0021] According to the "Chinese Pharmacopoeia" 2015 edition four general rules 0521 gas chromatography determination.

[0022] Experimental method and process:

[0023] 1. Instruments and reagents

[0024] Chromatograph: GC-2010PLUS gas chromatograph

[0025] Analytical balance: BSA224S type (manufacturer: Sartorius)

[0026] Test product: a drug preparation to be tested, known to contain BDDE residue 1ug / g.

[0027] 2. Chromatographic conditions and system adaptability

[0028] Chromatographic column: DB-1 (30m×0.53mm×1.5um), injection port: temperature 220°C, constant flow rate: 3mL / min, split method: 20:1; column temperature: 180°C, maintain for 10 minutes. ...

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Abstract

The invention relates to a BDDE residue detection method, comprising the following steps: firstly preparing a BDDE solution of 1.0mg / ml as a reference solution; then dissolving a sample by using ethyl alcohol, and centrifugally extracting to obtain a test article solution; finally detecting by adopting a gas chromatographic method FID detector. The method is used for detecting a residual solvent of BDDE, thus effectively solving the problems of personnel unsafety and environmental pollution caused by adopting chloroform as a sample to extract the solvent.

Description

technical field [0001] The invention relates to a method for detecting BDDE residues. Background technique [0002] BDDE is 1,4-butanediol diglycidyl ether, a colorless transparent liquid, soluble in water, and is a commonly used cross-linking agent. Studies have shown that BDDE has a certain risk of carcinogenicity, so it is necessary to control the residual amount of BDDE. At present, the industry quality standard for determining the residual amount of BDDE uses chloroform as a solvent. Chloroform reacts with oxygen in the air when exposed to light, and gradually decomposes to generate highly toxic phosgene and hydrogen chloride, which have the possibility of carcinogenicity and are quite harmful to experimenters. The experimental results show that the separation effect of BDDE is not good. Contents of the invention [0003] The purpose of this invention is to provide a kind of detection method of BDDE, to overcome the weak point in the above-mentioned detection method...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/06
CPCG01N30/06
Inventor 罗丽王旭敏熊祥龙
Owner ZHEJIANG JINGJIA MEDICAL TECH CO LTD
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