SF/T 0063-2020 in English

VALID

General rules for method validation in forensic toxicology

Issued on:2020-05-29
Implemented on:2020-05-29
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $240.00
$233.00

Standard No:	SF/T 0063-2020
Document status:	VALID
Title in English:	General rules for method validation in forensic toxicology
Title in Chinese:	法医毒物分析方法验证通则
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2020-05-29
Implemented on:	2020-05-29
Chinese Classification:	C06-Legal medical expert
Professional Classification:	SF-
Related Keywords:	method validation systematic method validation system core validation indicators validation type forensic toxicology introduction standard background forensic toxicology detection
Related Topics:	forensic analysis Forensic Method Validation Criteria poison method validation Analytical Method Validation Analytical Method Validation method validation Analytical method co-validation iso method validation Method Validation Scope Analytical Equipment Validation Chromatographic method validation Method Validation for Routine Analysis verified the method Analytical method Method Validation Specifications Method Validation Scope Analyte Analytical Method Validation Precision Analytical verification Method certificate Method Validation Scope Forensic Peak Pattern Analysis Analytical method validation two and a half sets day-to-day precision Verification method two Method Validation Selectivity Principles of Method Validation Toxicity verification Analytical blank Method validation part forensic dna analysis Total methodology validation Toxicology analysis Flow Method Validation Analyte method Quality Analysis Verification Method Fluoride Method Validation Method prevalidation Pre-validation of analytical methods Validation of analytical methods for in vitro samples Bioanalysis Bioanalysis forensic analysis Medical verification Material Validation Analysis Bioanalyzer Validation Verification Method Technology Analytical method pre-validation Analytical method pre-validation Common use of physical evidence Toxicology analysis What is the method of verification Analytical method validation and analytical method validation Material Validation Analysis Analytical Method Validation Procedures Physical Validation Analysis Methodology Validation Substances UV Analysis Method Validation Qualitative and Quantitative Analysis Methods Proficiency Testing Analysis Method Toxic analysis Analyte method Drug Analysis Toxicity method verification Evaluation of Analytical Method Validation Methodological validation external standard method The difference between analytical method validation and analytical method validation USP Sterility Analytical Method Validation Are standards used for verification of analytical methods? 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Analytical method validation management system Validation limits for liquid phase analysis methods Bioanalytical method validates ligand binding Full validation of bioanalytical method validation types Analytical method validation for specific forced degradation Pharmaceutical Analysis Methodology Validation Plan Analytical method validation pipettes Analytical method linear range verification method Validation requirements for linear range of analytical methods Analytical method limit validation Pharmacopoeia Analytical Method Validation Requirements Three Principles for Validation of Analytical Methods Analytical method validation charges Analytical method verification repeatability Methodological prevalidation Analytical method validation bias One picture to understand analysis methodology verification Analytical method accuracy verification Method transfer part verification UV analysis method validation plan Hanlikan method validation Analytical methodology validation purpose How to achieve durability in analytical method validation Drug analysis method validation process Lack of validation of pharmacopoeial analytical methods Instrumental Analysis Methodology Validation Contents of dissolution analysis method validation Liquid phase methodology verification failed Standard addition method analytical method validation Analytical method validation management Non-standard method verification Demonstration of drug analysis methods Starting material method validation Flow cytometry methodology validation Drug analysis method establishment and verification changes Method validation plan for starting materials and related substances High-throughput analytical methods Pharmacopeial methods do not require method validation Microscopic analysis method validation How to verify the accuracy of analytical methods Validation of durability of analytical methods in pharmacopoeias of various countries Analytical method development and validation of starting materials Area Percent Analysis Method Validation Verification methods for chromatographic quantitative analysis usually include Methodological validation content for biological sample analysis verify Methods for drug analysis and verification Validation of analytical methods in Part IV of the Chinese Pharmacopoeia European Pharmacopoeia Analytical Method Validation gm/t 0063 Moisture analysis method validation Optical rotation analysis method verification Analytical method linearity Plant exosome verification method Starting material method validation case Analytical methods and validation of drugs Analytical method validation repeatability requirements sf/t 0030 t/cpcif 0063-2020 t/cpcif0063-2020 Drug methodology validation Validation of Diazepam Analytical Methods Validation of analytical methodology in Chinese Pharmacopoeia European Pharmacopoeia Analytical Method Validation Contents API analysis method verification content Validation of Rheological Design Analysis Methods The purpose and method of three-batch verification of drug analysis Analytical method to verify gap items Partial and full validation of analytical methods How to validate analytical methods Scenario for revalidation of analytical methods Changes in reference materials for analytical method validation Pharmacopoeia Analytical Methodology Validation Validation of analytical methods for non-major components Bioanalytical Methodology Validation in Pharmacopoeias Validation of analytical methodology

本标准规定了生物基质中毒（药）物及其代谢物分析方法验证的基本要求。
本标准适用于实验室对非标准方法、实验室制定的方法、超出其预定范围使用的标准方法以及扩充、修改过的标准方法等进行方法验证。本标准只涉及色谱和色谱-质谱联用分析方法且不包括采样部分。

Introduction

Standard Background and Scope of Application

This standard, as a technical specification for the judicial administration industry, establishes a systematic method validation system for the application of analytical equipment such as liquid chromatographs and gas chromatography-mass spectrometry in forensic toxicology detection. It is applicable to the laboratory's validation process of non-standard methods, expanded methods, and modified methods.

Comparison of core validation indicators

Validation type	Screening analysis	Qualitative analysis	Quantitative analysis
Required indicators	4 items	6 items	11 items
Key differences	Only detection limit	Increase matrix effect	Linearity/precision/accuracy required
RSD requirements	-	-	≤15%(quantification limit≤20%)

Analysis of key technical points

1. Selectivity verification

It is required to analyze 10 blank samples from different sources and eliminate interference by optimizing chromatographic conditions. The example shows that when using triple quadrupole mass spectrometry, at least 2 pairs of characteristic ion pairs need to be monitored to ensure specificity.

2. Delay effect control

The blank sample response after high concentration samples should be less than 10% of the quantification limit. The case in Appendix A of the standard shows that a slight delay effect occurs after a 2000ng/mL ketamine sample, but it can be effectively controlled by the system flushing procedure.

3. Linear range establishment

Required:
- More than 6 concentration gradient points
- The lowest point is close to the limit of quantitation
- Use 1/x or 1/x² weighting to correct heteroscedasticity
In the example, the R² of ketamine in the range of 10-1000ng/mL is>0.999

Implementation suggestions

Key points of LC-MS method development

1. Matrix effect assessment: It is recommended to use 6 matrices from different sources. When RSD>15%, the extraction method needs to be optimized
2. Stability validation: It should include 3 freeze-thaw cycle tests and sample stability test after 72h treatment
3. Document management: It is recommended to establish a complete validation report including raw data, chromatograms, and calculation process

Technology Evolution Analysis

Main improvements of this standard compared with GA/T 122:
1. Added special verification requirements for LC-MS matrix effect
2. Clarified the quantitative evaluation method of delayed effect
3. Introduced weighted regression to deal with nonlinear problems
4. Separated the evaluation of extraction recovery and matrix effect

More samples: GB 18306-2015 GB 50021-2001(2009) QC/T 942-2021

Sample only — not a preview of SF/T 0063-2020

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