SN/T 5326.2-2020 in English

VALID

Guideline on validation of test methods for food and cosmetics of import and export Part 2: Chemical method

Issued on:2020-12-30
Implemented on:2021-07-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $180.00
$175.00

Standard No:	SN/T 5326.2-2020
Document status:	VALID
Title in English:	Guideline on validation of test methods for food and cosmetics of import and export Part 2: Chemical method
Title in Chinese:	进出口食品化妆品专业分析方法验证指南第2部分：化学方法
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2020-12-30
Implemented on:	2021-07-01
Professional Classification:	SN-Import&Export Inspection
Related Topics:	Method Validation Criteria import and export food method validation Analytical Method Validation professional analysis Analytical Method Validation method validation Analytical method co-validation Chemical Methods Guide Guidelines for Validation and Validation of Chemical Analytical Methods for Conformity Assessment food cosmetics Guidelines for Validation of Analytical Methods How long does method validation take Several batches of methodological validation southern food industry Method certificate Analytical method specificity Verification Guide Samples for method validation Verification Guide Cosmetic ingredient testing Method validation part Exclusive to Methodology Validation How to use cosmetics Total methodology validation food imports Cosmetic ingredient analysis method How to analyze cosmetic ingredients Cosmetic Analysis import and export food professional analysis 5 Food Analysis Methods No. specialization Pre-validation of analytical methods Validation of analytical methods for in vitro samples Sample Method Validation Methodology Validation Sample Chemical Analysis Major food cosmetics Analytical method pre-validation Analytical method pre-validation Flow method validation Food classification method Analytical Method Validation Procedures Food classification method Cosmetics are not tested on animals Food Chemistry Frontiers Cosmetic ingredient analysis method Component Analysis Methods of Cosmetics Proficiency Testing Analysis Method Method validation electrochemical window method food certification chemical constituents in food chemical method food Import and export of food and cosmetics Classification of food analysis methods Import machine professional Methodological validation external standard method Method Validation Method Detection Limit MDL USP Sterility Analytical Method Validation Are standards used for verification of analytical methods? Digestion of food physical and chemical analysis experiments specialty chemicals Thermogravimetric Analysis Methodology Validation What are the regulations for analytical method validation? Applicable Scope of Analytical Methodology Validation Dissolution Methodology Validation Analytical method validation example Validation of Pharmacopeial Analytical Methods Analytical Methodology Validation Guidance and Regulations Dissolution Methodology Validation Plan Which part of the Pharmacopoeia is the methodological validation in? Validation of pharmaceutical analytical methods Method validation parameters What samples should be used for validation of analytical methods? Validation of applicable analytical methods for microbiological methods of chemicals Verification of suitability of analytical methods Technical verification methods Analytical Methods Guidelines Food method validation and expansion Method verification repeatability Validation of Pharmacopeial Analytical Methods Analytical Method Validation Pharmacopoeia Joint validation of analytical methods Cosmetics process verification group Analytical method validation for specific forced degradation Pharmaceutical Analysis Methodology Validation Plan Analytical method validation pipettes Analytical method linear range verification method Analytical method validation charges Methodological prevalidation Analytical method specificity Cosmetic Analysis Methods One picture to understand analysis methodology verification Method transfer part verification Repeatable method validation Methodological Validation Pharmacopoeia Analytical methodology validation purpose Pharmacopoeia Part 4 Methodology Validation How to achieve durability in analytical method validation Instrumental Analysis Methodology Validation Common analytical methods for food rheology Contents of dissolution analysis method validation Implementation of verification of physical and chemical analysis methods by the trustee Dissolution Methodology Validation Repeatability Flow cytometry methodology validation Food Analysis and Processing Methods Methodological validation content for biological sample analysis Validation of analytical methods in Part IV of the Chinese Pharmacopoeia Main methods of food sample purification Moisture analysis method validation Optical rotation analysis method verification Analytical method validation is required when Validation of Rheological Design Analysis Methods Partial and full validation of analytical methods How to validate analytical methods Changes in reference materials for analytical method validation Pharmacopoeia Analytical Methodology Validation Validation of analytical methodology

Introduction

Analysis of the core content of the standard

As a special guidance document for the verification of testing methods for imported and exported food and cosmetics, this standard systematically regulates the technical framework for the verification of chemical analysis methods. The standard clarifies for the first time the differentiated verification requirements for qualitative/quantitative methods and innovatively uses probability statistics to determine the detection limit.

Key Performance Parameter Verification Specifications

Parameter Type	Qualitative method	Quantitative method	Verification points
Specificity	Required	Required	The separation ability of the target and interferences needs to be verified
Detection limit	Required	Required	Use probability statistics method (95% detection probability)
Quantitative limit	-	Required	≥3 times the detection limit and signal-to-noise ratio ≥10

Key points for verification implementation

Sample preparation specifications

The standard requires that verification samples should contain 5 concentration levels, with a focus on:

Limit of quantification concentration
Concentration level of concern (such as maximum residue limit)
Highest concentration level

Actual case: The LOD verification of clenbuterol detection in pork needs to achieve a detection rate of 95% at a concentration level of 0.2μg/kg (19/20 samples).

Technology Evolution Analysis

Compared with traditional verification methods, this standard has three major breakthroughs:

Introduction of Youden denaturation resistance test to evaluate the robustness of the method
Clearly specify the performance parameters that need to be independently verified for different matrices
Specify the linearity requirements of the standard curve (r≥0.99)

More samples: NB/T 47013.2-2015 DL/T 5154-2012 GB 18306-2015

Sample only — not a preview of SN/T 5326.2-2020

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