Method for determining content of halogenated acid in chloral hydrate or preparation thereof

A technology of chloral hydrate and halogenated acid, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve problems such as the determination method of halogenated acid content in unrecorded chloral hydrate preparations, and avoid factors that interfere with the test results , high sensitivity and high accuracy

Active Publication Date: 2021-02-09
TEFENG PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, in the existing quality standards for chloral hydrate raw materials and preparations (including the standards of "Chinese Pharmacopoeia", "US Pharmacopo

Method used

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  • Method for determining content of halogenated acid in chloral hydrate or preparation thereof
  • Method for determining content of halogenated acid in chloral hydrate or preparation thereof
  • Method for determining content of halogenated acid in chloral hydrate or preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1 3

[0060] The detection method of embodiment 1 trichloroacetic acid and dichloroacetic acid

[0061] 1.1 Instruments and reagents

[0062] Instruments: gas chromatograph, GC-2014, Shimadzu Corporation, Japan; 7890B, Agilent Corporation, USA; electronic analytical balance, CPA225D, Sartorius Scientific Instrument Co., Ltd., etc.

[0063] Reagents: reference substance dichloroacetic acid, content 98.4%, purchased from Dr.Ehrenstorfer GmbH, reference substance trichloroacetic acid, content ≥99.0%, purchased from Tokyo Chemical Industry Co., Ltd., methyl tert-butyl ether and methanol are chromatographically pure, The remaining reagents (concentrated sulfuric acid (density 1.84g / mL), anhydrous sodium sulfate, sodium chloride, sodium hydroxide, sodium bicarbonate, etc.) were of analytical grade, and the water was self-made ultrapure water.

[0064] 10% methanolic sulfuric acid solution: Slowly add 5ml of sulfuric acid to 45ml of methanol under stirring, and leave to room temperature. ...

Embodiment 2 3

[0087] Example 2 Trichloroacetic acid detection method verification

[0088] overview

[0089] The method for the detection of TCA was validated and the results of the validation are summarized in Table 1.

[0090] Table 1 Summary of Trichloroacetic Acid Detection Method Validation

[0091]

[0092] specific description

[0093] 2.1 Instruments and reagents

[0094] 2.1.1 Instruments and equipment

[0095] Table 2 Instruments and equipment

[0096] serial number equipment name model manufacturer 1 Gas Chromatograph GC-2014 Shimadzu Corporation 2 Gas Chromatograph 7890B Agilent Corporation 3 Electronic balance CPA225D Sartorius Scientific Instruments Ltd. 4 Electronic balance BSA224S Sartorius Scientific Instruments Ltd. 5 Electric constant temperature water bath DZKW-S-4 Beijing Guangming Medical Instrument Co., Ltd. 6 Electric blast drying oven GZX-9246MBE Shanghai Boxun Industrial Co., Ltd. Med...

Embodiment 3 2

[0187] Embodiment 3 dichloroacetic acid detection method validation

[0188] overview

[0189] The method for the detection of dichloroacetic acid was validated and the results of the validation are summarized in Table 11.

[0190] Table 11 Summary of Dichloroacetic Acid Detection Method Validation

[0191]

[0192] specific description

[0193] 3.1 Instruments and reagents

[0194] 3.1.1 Instruments and equipment

[0195] Table 12 Instruments and equipment

[0196] serial number equipment name model manufacturer 1 Gas Chromatograph 7890B Agilent Corporation 2 Electronic balance CPA225D Sartorius Scientific Instruments Ltd. 3 Electronic balance BSA224S Sartorius Scientific Instruments Ltd. 4 Electric blast drying oven GZX-9246MBE Shanghai Boxun Industrial Co., Ltd. Medical Equipment

[0197] 3.1.2 Reagents

[0198] Chloral hydrate concentrate (74.48%, w / w) (batch number: 20181101, 2181102), Nanjing Tefeng Phar...

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Abstract

The invention relates to a method for detecting the content of impurities in a drug, in particular to a method for determining the content of halogenated acid in chloral hydrate or a preparation thereof through gas chromatography.

Description

technical field [0001] The application relates to a detection method for impurity content in medicines, in particular to a method for determining the content of halogenated acids in chloral hydrate or its preparations by gas chromatography. Background technique [0002] On October 27, 2017, the International Agency for Research on Cancer of the World Health Organization released a preliminary list of carcinogens, and both trichloroacetic acid and dichloroacetic acid are included in the list of 2B carcinogens. [0003] However, in the existing quality standards for chloral hydrate raw materials and preparations (including the standards of "Chinese Pharmacopoeia", "US Pharmacopoeia", "European Pharmacopoeia", "Japanese Pharmacopoeia", etc.), none of the chloral hydrate preparations Determination method of halogenated acid content. Contents of the invention [0004] The invention provides the method for measuring halogenated acid content in chloral hydrate or its preparation...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06G01N30/88
Inventor 云琦袁子惠吴小青陶亮
Owner TEFENG PHARM CO LTD
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