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Method for determining the content of halogenated acids in chloral hydrate or its preparations

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 , Easy to operate, high sensitivity effect

Active Publication Date: 2022-01-04
TEFENG PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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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 Pharmacopoeia", "European Pharmacopoeia", "Japanese Pharmacopoeia", etc.), none of the chloral hydrate preparations Method for Determination of Halogenated Acid Content in Medium

Method used

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  • Method for determining the content of halogenated acids in chloral hydrate or its preparations
  • Method for determining the content of halogenated acids in chloral hydrate or its preparations
  • Method for determining the content of halogenated acids in chloral hydrate or its preparations

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, USA; Electronic Analytical Balance, CPA225D, Sartorius Scientific Instruments Co., Ltd., etc.

[0063] Reagent: 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: 1.84 g / mL), anhydrous sodium sulfate, sodium chloride, sodium hydroxide, sodium bicarbonate, etc.) are of analytical grade, and the water is self-made ultrapure water.

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

[006...

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 USA 3 Electronic balance CPA225D Sartorius Scientific Instruments Ltd. 4 Electronic balance BSA224S Sartorius Scientific Instruments Ltd. 5 Electric thermostatic water bath DZKW-S-4 Beijing Bright Medical Instrument Co., Ltd. 6 Electric blast drying oven GZX-9246MBE Shanghai Boxun Industrial Co., Ltd. medical equipment ...

Embodiment 3 2

[0187] Embodiment 3 Dichloroacetic acid detection method verification

[0188] Overview

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

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

[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 USA 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 numbers: 20181101, 2181102), Nanjing Tefeng Pharmaceutical Co...

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Abstract

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.

Description

technical field [0001] The present application relates to a method for detecting the content of impurities in medicines, in particular to a method for determining the content of halogenated acids in chloral hydrate or its preparation by gas chromatography. Background technique [0002] On October 27, 2017, the International Agency for Research on Cancer of the World Health Organization announced the preliminary list of carcinogens, and both trichloroacetic acid and dichloroacetic acid are in the list of 2B carcinogens. [0003] However, in the existing quality standards of chloral hydrate raw materials and preparations (including the standards of "Chinese Pharmacopoeia", "US Pharmacopoeia", "European Pharmacopoeia", "Japanese Pharmacopoeia", etc.), chloral hydrate preparations are not included. Method for the determination of halogenated acid content in . SUMMARY OF THE INVENTION [0004] The present invention provides a method for determining the content of halogenated a...

Claims

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Application Information

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Patent Type & Authority Patents(China)
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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