GB/T 29637-2023 (English Version)

Standard No.: GB/T 29637-2023
Language: Chinese, Available in English version
Release Date: 2023
Published By: General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
Latest: GB/T 29637-2023
Replace: GB/T 29637-2013

Scope: This document describes the principles, reagents, instruments and materials, test analysis steps and result evaluation of ketamine's gas chromatography-mass spectrometry (GC-MS), liquid chromatography (LC), liquid chromatography-mass spectrometry (LC-MS) qualitative test methods and liquid chromatography (LC) quantitative test methods. This document is applicable to the qualitative and quantitative analysis of ketamine in suspected drugs.

Introduction

Interpretation of the National Standard of the People's Republic of China GB/T 29637-2023

This standard specifies the qualitative and quantitative test methods for ketamine in suspected drugs by gas chromatography-mass spectrometry (GC-MS), liquid chromatography (LC) and liquid chromatography-mass spectrometry (LC-MS), and is applicable to public security organs and relevant testing institutions.

Comparison of standard frameworks

Project dimensions	Old version GB/T 29637—2013	New standard GB/T 29637—2023
Scope	Only covers gas chromatography and gas chromatography-mass spectrometry methods	Newly added liquid chromatography and liquid chromatography-mass spectrometry methods
Principle update	Liquid chromatography related technologies are not mentioned	Liquid chromatography and LC-MS qualitative analysis methods are added
Reagent requirements	General reagents, no detailed classification	Reagent grades are distinguished by GC-MS and LC-MS
Analysis steps	No specific specifications for quantitative analysis	Added a new liquid chromatography quantitative analysis process

Recommendations for standard implementation

1. Recommendations for laboratory equipment configuration

GC-MS instrument: Gas chromatography-mass spectrometer equipped with electron impact source (EI), DB-5MS or DB-35MS capillary columns are recommended.

LC-MS instrument: Liquid chromatography-mass spectrometer equipped with electrospray ionization source (ESI), BEH C18 chromatographic column is recommended.

2. Reagent and Standard Material Management

Purchase GC-MS and LC-MS grade reagents in strict accordance with standard requirements, and establish records of standard material use to ensure traceability.

3. Analytical method optimization

Qualitative analysis: Combine mass spectrometry characteristic ions and retention time for comprehensive judgment to ensure the accuracy of positive results.
Quantitative analysis: Select an appropriate standard curve or single-point quantitative method based on the sample pre-analysis content. It is recommended to use the external standard standard curve method to improve accuracy.

4. Data Recording and Reporting

Establish a unified data management template to record instrument parameters, reagent information, analysis results and uncertainty assessment, and attach detailed spectral descriptions.

GB/T 29637-2023 Referenced Document

GA/T 122 Toxicology Analysis Terminology
GB/T 27418 Guide to the evaluation and expression of uncertainty in measurement
GB/T 6682 Water for analytical laboratory use.Specification and test methods

GB/T 29637-2023 history

2023 GB/T 29637-2023 Ketamine test in suspected drugs
2013 GB/T 29637-2013 GC and GC-MS examination methods for ketamine in suspected drug