GB/T 39999-2021 English PDF

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GB/T 39999-2021: Determination of 15 kinds of prohibited quinolone-type antibiotics in cosmetics including enrofloxacin - Liquid chromatography-tandem mass spectrometry
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 39999-2021	259	Add to Cart	3 days	Determination of 15 kinds of prohibited quinolone-type antibiotics in cosmetics including enrofloxacin - Liquid chromatography-tandem mass spectrometry	Valid

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Basic data

Standard ID: GB/T 39999-2021 (GB/T39999-2021)
Description (Translated English): Determination of 15 kinds of prohibited quinolone-type antibiotics in cosmetics including enrofloxacin - Liquid chromatography-tandem mass spectrometry
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: Y42
Word Count Estimation: 14,161
Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration

GB/T 39999-2021: Determination of 15 kinds of prohibited quinolone-type antibiotics in cosmetics including enrofloxacin - Liquid chromatography-tandem mass spectrometry

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Determination of 15 kinds of prohibited quinolone-type antibiotics in cosmetics including enrofloxacin - Liquid chromatography-tandem mass spectrometry ICS 71.100.70 Y42 National Standards of People's Republic of China Enrofloxacin and other 15 banned quinolones in cosmetics Determination of antibiotics by liquid chromatography-tandem mass spectrometry Released on 2021-04-30 2021-11-01 implementation State Administration of Market Supervision and Administration Issued by the National Standardization Management Committee

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard was proposed by the China National Light Industry Council. This standard is under the jurisdiction of the National Standardization Technical Committee for Fragrance, Flavor and Cosmetics (SAC/TC257). Drafting organizations of this standard. Jiangsu Product Quality Supervision and Inspection Institute, Jiawenli (Fujian) Cosmetics Co., Ltd., Infinitus (China) Co., Ltd., Suzhou Luye Daily Necessities Co., Ltd., Jiangsu Qilikang Skin Pharmaceutical Co., Ltd., Suzhou Shipu Testing Technology Co., Ltd., Guangzhou Quality Supervision and Inspection Research Institute, Shanghai Daily Chemical Industry Research Institute, Shanghai Xiangyi Herbal Cosmetics Co., Ltd., Ou Shiman Biological Co., Ltd. Co., Ltd., Guangzhou Guerlain Cosmetics Co., Ltd., Perfect (Guangdong) Daily Necessities Co., Ltd., Food and Drug Supervision and Inspection Research of Jiangsu Province Institute, Changzhou Food and Drug Supervision and Inspection Center, Hebei Food Inspection and Research Institute, Changzhou Inspection and Testing Standards and Certification Institute. The main drafters of this standard. Lu Jian, Qu Mei, Cao Qianwen, Rao Huanwen, Yang Qiongli, Liu Dong, Lu Zhi, Xun Zhiqing, Shen Min, Wu Ke, Zhang Zheng, Zhang Xiaoqiang, Zou Jie, Yang Yang, Zhang Lihua, Gu Jie, Sun Hongmei, Hou Aixia, Yang Mei, Zhang Yan, Lin Jianping, Song Shuwen, Zhou Qi, Li Shuqin, Yang Anhui, Zhang Yanhong, Fan Sufang, Huang Jinfeng, Sun Shanshan, Ma Ming, Chen Hanjin, Chen Xiaozhen, Guo Xindong, Wu Yuluan, Peng Lu, Wang Changjie, Wu Zhongping.

Introduction

The tested substances in this standard are prohibited substances stipulated in my country's "Safety Technical Specifications for Cosmetics (2015 Edition)". Prohibited substances refer to substances that cannot be added to cosmetics as raw materials or components in cosmetics production. "Cosmetics Safety Technical Specification (2015 Edition)'' stipulates. If it is technically unavoidable that prohibited substances are brought into cosmetics as impurities, the limited amount of national regulations shall comply with its regulations. If the limit is not specified, a safety risk assessment should be carried out to ensure that no harm to human health is allowed under normal, reasonable and foreseeable use conditions. Health hazards. my country has not yet stipulated the limit values of these substances. The formulation of this standard only provides detection methods for the determination of these substances in cosmetics. Enrofloxacin and other 15 banned quinolones in cosmetics Determination of antibiotics by liquid chromatography-tandem mass spectrometry

1 Scope

This standard specifies the principles, reagents or methods of liquid chromatography-tandem mass spectrometry for 15 banned quinolone antibiotics in cosmetics. Materials, equipment, test procedures, annual results, recovery rate and precision, tolerances, etc. This standard is applicable to enoxacin, maribofloxacin, norfloxacin, ofloxacin, ofloxacin, water, emulsion and non-wax-based cream cosmetics. Fleroxacin, Pefloxacin, Ciprofloxacin, Lomefloxacin, Danofloxacin, Enrofloxacin, Orbifloxacin, Sarafloxacin, Sparfloxacin, Difloxacin Determination of Star and Moxifloxacin. This standard does not apply to the determination of quinolone antibiotics in powder cosmetics. The detection limit of 15 quinolone antibiotics in this standard is 0.15mg/kg, and the limit of quantification is 0.50mg/kg.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document. GB/T 6682 Analytical laboratory water specifications and test methods

3 Principle

The 15 quinolone antibiotics in the sample were extracted with acidified acetonitrile. After centrifugation, the extracts were combined and concentrated, and purified with n-hexane. Chromatography-tandem mass spectrometer determination, external standard method quantification.

4 Reagents or materials

Unless otherwise stated, all reagents used are of analytical grade. 4.1 Water, GB/T 6682, level one. 4.2 Acetonitrile. chromatographically pure. 4.3 Formic acid. chromatographically pure. 4.4 n-hexane. chromatographically pure. 4.5 0.1% formic acid acetonitrile solution. accurately measure 1.0mL formic acid (4.3) into a 1000mL volumetric flask, and dilute to the mark with acetonitrile (4.2). 4.6 0.1% formic acid solution. accurately measure 1.0mL formic acid (4.3) into a 1000mL volumetric flask and dilute to the mark with water. 4.7 Constant volume solution. accurately measure 10mL acetonitrile (4.2) and 90mL 0.1% formic acid solution (4.6), and mix. 4.8 Acetonitrile saturated n-hexane solution. Measure 20mL acetonitrile (4.2), add to 50mL n-hexane (4.4), mix well, let stand, and supernatant Liquid reserve. 4.9 Standard material. the purity is not less than 98%, the Chinese name, English name, CAS number, and score of 15 kinds of quinolone antibiotic standard materials The sub-formula, relative molecular mass and chemical structure formula are shown in Table A.1 in Appendix A. 4.10 Mixed standard working solution. accurately weigh appropriate amount of standard substance (4.9) (accurate to 0.1mg), and prepare the quality with acetonitrile (4.2) A single-label standard stock solution with a concentration of 1000μg/mL (stored at 4°C and protected from light, can be stored for 3 months). Accurately transfer the standard stock of each single standard 0.25mL of the solution was placed in a 50mL volumetric flask, and the volume was fixed with acetonitrile (4.2) to prepare a mixed standard intermediate working solution (each 5μg/mL, now prepared use). Take the corresponding blank sample and process it in accordance with 6.1 to obtain the matrix solution. Accurately pipette an appropriate amount of mixed standard intermediate working solution, and use The matrix solution is gradually diluted into a series of mixed mass concentrations of 5.0 μg/L, 10 μg/L, 20 μg/L, 50 μg/L, 100 μg/L, and.200 μg/L. Meet the standard working solution (now equipped and used now). 4.11 Membrane. PTFE membrane with a pore size of 0.22μm.

5 Equipment

5.1 Liquid chromatography-triple quadrupole mass spectrometer. equipped with an electrospray ion source. 5.2 Analytical balance. Sensitivity is 0.001g and 0.0001g. 5.3 Vortex oscillator. 5.4 Ultrasonic cleaner. working frequency is not less than 40kHz. 5.5 Centrifuge. the maximum speed is not less than 4000r/min. 5.6 Nitrogen blowing instrument.

6 Test procedure

6.1 Sample processing Weigh 1.0g of the sample (accurate to 0.001g), place it in a 15mL plastic centrifuge tube with a stopper, and add 8mL 0.1% formic acid acetonitrile solution (4.5), vortex for 1 min, ultrasonic extraction for 20 min, centrifuge at 4000 r/min for 2 min, and take the supernatant. Use 8mL 0.1% formic acid for the residue The acetonitrile solution (4.5) was extracted once again, the supernatants were combined, and the volume was adjusted to 25 mL with 0.1% formic acid acetonitrile solution (4.5). Accurate transfer 1.0mL of the above extraction solution, blow nitrogen to nearly dry in a water bath at 50℃, dilute to 2.0mL with constant volume solution (4.7), add 2mL saturated with acetonitrile Hexane solution (4.8), vortex for 1min, centrifuge at 4000r/min for 2min, the lower layer of liquid is filtered through a filter membrane and then used for liquid chromatography-triple quadruple Measured by pole-mass spectrometer. 6.2 Determination 6.2.1 Reference working conditions of liquid chromatography The reference working conditions of liquid chromatography are as follows. a) Chromatographic column. C18 column, 1.9μm, 100mm×2.1mm (inner diameter) or C18 column, 5.0μm, 150mm×4.6mm (inner diameter); b) Mobile phase. A. 0.1% formic acid acetonitrile solution (4.5) and B. 0.1% formic acid solution (4.6), gradient elution, gradient elution program See Table 1; c) Flow rate. 0.3mL/min; d) Column temperature. 30℃; e) Injection volume. 5μL. ......

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