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GB/T 36908-2018 English PDF (GBT36908-2018)

GB/T 36908-2018 English PDF (GBT36908-2018)

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GB/T 36908-2018: Limit and determination of sensitizing dyes in dye products
This Standard specifies the limit requirements and determination methods for 20 kinds of sensitizing dyes (see Appendix A) in dye products. This Standard is applicable to various formulations of dye products.
GB/T 36908-2018
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 71.100.01; 87.060.10
G 55
Limit and Determination of Sensitizing Dyes in Dye
Products
ISSUED ON: DECEMBER 28, 2018
IMPLEMENTED ON: NOVEMBER 01, 2019
Issued by: State Administration for Market Regulation;
Standardization Administration of PRC.
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative References ... 4
3 Requirements ... 4
4 Principle ... 4
5 Test Method ... 5
6 Minimum Detection Limit, Precision and Recovery Rate ... 10
7 Test Report ... 10
Appendix A (Normative) Information on 20 Kinds of Sensitizing Dyes ... 11 Appendix B (Informative) Chromatogram for Determination by the Sensitizing Dye HPLC-DAD Method and Mass Spectrum for Determination by the HPLC-
MS Method ... 12
Limit and Determination of Sensitizing Dyes in Dye
Products
Warning - Personnel using this standard shall have practical experience in formal laboratory work. This standard does not point out all possible safety issues. The user is responsible for taking appropriate safety and health measures and ensuring compliance with the conditions stipulated by relevant national laws and regulations.
1 Scope
This Standard specifies the limit requirements and determination methods for 20 kinds of sensitizing dyes (see Appendix A) in dye products.
This Standard is applicable to various formulations of dye products.
2 Normative References
The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) is applicable to this document.
GB/T 6682-2008 Water for Analytical Laboratory Use - Specification and Test Methods (ISO 3696:1987, MOD)
GB/T 8170-2008 Rules of Rounding off for Numerical Values and Expression and Judgement of Limiting Values
3 Requirements
The content of each sensitizing dye (see Appendix A) in the dye products shall be no greater than 150mg/kg.
4 Principle
The sensitizing dyes in the dyes are dissolved out with methanol as solvent; and each sensitizing dye is separated and qualitatively determined by high performance liquid chromatography-diode array detector (HPLC-DAD), and quantified by the peak area external standard method. The qualitative determination of the detected and uncertain samples was carried out by liquid chromatography-tandem mass spectrometry (HPLC- MS/MS).
5 Test Method
5.1 General provisions
Unless otherwise specified, only use reagents confirmed to be analytically pure and the Class-III water specified in GB/T 6682-2008. The test result is judged according to the rounding value comparison method in 4.3.3 of GB/T 8170-2008.
5.2 Reagents and materials
5.2.1 Standard product of sensitizing dye (see Appendix A).
5.2.2 Acetonitrile: chromatographically pure.
5.2.3 Methanol: chromatographically pure.
5.2.4 Sodium acetate aqueous solution: 0.01mol/L.
5.2.5 PTFE membrane filter head: 0.45μm.
5.3 Apparatus
5.3.1 Liquid chromatograph: infusion pump - flow range of 0.1mL/min~5.0mL/min, within this range its flow stability is ±1%; with diode array detector (DAD). 5.3.2 Chromatographic column: a stainless-steel column with a length of 150mm and an inner diameter of 3.9mm; the stationary phase is RP18, and the particle size is 5μm. 5.3.3 Chromatography workstation or integrator.
5.3.4 Flat-head micro syringe or autosampler.
5.3.5 Ultrasonic generator.
5.3.6 Conical flask with abrasive stopper: 150mL.
5.4 Analysis conditions of liquid chromatography
5.4.1 Flow rate: 0.8mL/min.
5.4.2 Column temperature: 40°C.
many types of liquid chromatography-mass spectrometers, the qualitative methods of instruments with different principles shall be different. The conditions provided in 5.5 are the parameters of the high-performance liquid chromatography-tandem mass spectrometer; other types of instruments may be set according to the characteristics of the instrument itself, as long as it can meet the accuracy of the qualitative. See Appendix A for the qualitative characteristic ions of 20 kinds of sensitizing dyes. 6 Minimum Detection Limit, Precision and Recovery
Rate
6.1 Minimum detection limit
The minimum detection limit of each sensitizing dye in this method is 10mg/kg. 6.2 Precision
In the same laboratory, the absolute difference between the two independent test results obtained by the same operator using the same equipment and the same test method against the same object under test in a short period of time shall be no greater than 10% of its arithmetic average.
6.3 Recovery rate
Use the standard addition method, add 1mL of the standard stock solution into the sample, determined by this method, not containing sensitizing dyes. Operate according to Clause 5, the measured recovery rate of sensitizing dye shall be 80%~120%.
7 Test Report
The test report shall give at least the following contents:
a) Sample description;
b) The used standard number;
c) test results;
d) The name and model of the used instrument;
e) Deviations from the standards;
f) Test date.
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