WS/T 684-2020 English PDF

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WS/T 684-2020: (Detection methods and evaluation requirements of antibacterial drugs in disinfectants and antibacterial agents)
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Basic data

Standard ID: WS/T 684-2020 (WS/T684-2020)
Description (Translated English): (Detection methods and evaluation requirements of antibacterial drugs in disinfectants and antibacterial agents)
Sector / Industry: Health Industry Standard (Recommended)
Classification of Chinese Standard: C50
Word Count Estimation: 21,237
Date of Issue: 2020-07-20
Date of Implementation: 2021-02-01
Regulation (derived from): State-health communication (2020) No. 14
Issuing agency(ies): National Health Commission

WS/T 684-2020: (Detection methods and evaluation requirements of antibacterial drugs in disinfectants and antibacterial agents)

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(Detection methods and evaluation requirements of antibacterial drugs in disinfectants and antibacterial agents) ICS 11.080 C 50 WS People's Republic of China Health Industry Standard Detection methods and evaluation requirements of antibacterial drugs in disinfectants and antibacterial agents Issued by the National Health Commission of the People's Republic of China

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Drafting organizations of this standard. Jiangsu Provincial Center for Disease Control and Prevention, China Center for Disease Control and Prevention, Environmental and Health Related Product Safety Institute, Beijing Municipal Center for Disease Control and Prevention, Jiangsu Institute of Food and Drug Inspection, China Pharmaceutical University, National Center for Food Safety Risk Assessment, Shandong Provincial Center for Disease Control and Prevention, Xuzhou Center for Disease Control and Prevention, Zhongda Hospital affiliated to Southeast University. The main drafters of this standard. Xu Yan, Wu Xiaosong, Zhu Feng, Hu Xiaojian, Wang Wei, Li Fang, Ji Wenliang, Zhang Liubo, Ding Xiaojing, Li Ge Yuan, Qian Hai, Cui Shuyu, Chen Yueying, Shen Jin, Li Yan, Zhao Yunfeng, Chen Dawei, Su Guanmin, Chang Guiqiu, Chu Hongliang, Tan Zhi, Fan Jingjing, Kong Qingfang, Sun Hong. Detection methods and evaluation requirements of antibacterial drugs in disinfectants and antibacterial agents

1 Scope

This standard specifies the testing methods and evaluation requirements for antibacterial drugs in disinfectants and antibacterial agents. This standard applies to tetracyclines (tetracycline, oxytetracycline, chlortetracycline, minocycline, doxycycline) in disinfectants and antibacterial agents, Macrolides (erythromycin), β-lactams (cefradine), sulfa (sulfadiazine), quinolones (ofloxacin, norfloxacin) Determination and evaluation of lincosamide (clindamycin), chloramphenicol (chloramphenicol) and other antibacterial drugs.

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 references, the latest version (including all amendments) applies to this document. GB/T 6682 Analytical laboratory water specifications and test methods Pharmacopoeia of the People's Republic of China

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Antibacterial drugs Drugs that have antibacterial and/or bactericidal activity and are used to prevent and treat bacterial infections, including antibiotics and prescription drugs Learn synthetic drugs.

4 Detection method

4.1 Principle The antibacterial drugs in the sample are ultrasonically extracted with methanol or acetonitrile. After the extract is filtered, it is mixed with water and used by ultra-high performance liquid chromatography-tandem mass spectrometry. Measured by instrument and quantified by internal standard method. 4.2 Reagents and materials Unless otherwise specified, the reagents used are all chromatographically pure, and the experimental water is the first grade water specified in GB/T 6682. 4.2.1 Reagents 4.2.1.1 Acetonitrile (CH3CN). 4.2.1.2 Formic acid (HCOOH). 4.2.1.3 Methanol (CH3OH). 4.2.1.4 Sodium chloride (NaCl). analytically pure. 4.2.2 Reagent preparation 4.2.2.1 0.1% formic acid aqueous solution. take 1.0 mL of formic acid, dilute to 1000 mL with water, and mix. 4.2.2.2 Methanol aqueous solution. Take 800 mL of methanol, add.200 mL of water, and mix well. 4.2.3 Standard products 4.2.4 Standard solution preparation 4.2.4.1 Standard stock solution (about 1.0 mg/mL). accurately weigh tetracycline, oxytetracycline, chlortetracycline, minocycline, doxycycline, About 10.0 mg of erythromycin, cefradine, sulfadiazine, ofloxacin, norfloxacin, clindamycin, and chloramphenicol in a 10 mL volumetric flask, Dissolve it with methanol and make it to the mark, prepare a standard stock solution with a concentration of approximately 1.0 mg/mL, and store it in a frozen state at -20℃±2˚C. The validity period is 3 months. 4.2.4.2 Mixed standard intermediate solution (10 μg/mL). accurately draw appropriate amounts of each single standard stock solution into a 25 mL volumetric flask, and use A Dilute with alcohol and make the volume up to the mark, prepare a mixed standard intermediate solution with a concentration of 10 μg/mL, store it in cold storage and avoid light, and the validity period is 1 month. 4.2.4.3 Internal standard compound standard stock solution (about 1.0 mg/mL). Weigh tetracycline-D6 and oxytetracycline-C22- respectively N2, minocycline-D6, doxycycline-D3, sulfadiazine-D6, cephalexin-D5, levofloxacin-D8, erythromycin-C-D3, Thiabendazole-D4, chloramphenicol-D5 about 10.0 mg in a 10 mL volumetric flask, dissolved in methanol and dilute to the mark, Prepare an internal standard stock solution with a concentration of about 1.0 mg/mL, at -20℃ Frozen storage at ±2˚C, valid for 6 months. 4.2.4.4 Standard intermediate solution of mixed internal standard compound. draw appropriate amount of single internal standard stock solution into 10 mL volumetric flask and dilute with methanol And dilute to the mark, prepare a 1 μg/mL mixed internal standard intermediate solution, store in refrigeration and avoid light, the validity period is 3 months. 4.2.4.5 Mixed standard solution. use methanol aqueous solution to prepare the standard intermediate solution of antibacterial drugs into a mixed standard series solution, such as 1 μg/L, 2 μg/L, 5 μg/L, 10 μg/L, 20 μg/L, 50 μg/L, 100 μg/L, the mixed internal standard compound concentration in each series of solutions is 10 μg/L, Ultra performance liquid chromatography-tandem mass spectrometer determination. Now equipped for temporary use. 4.2.5 Materials Organic filter membrane. pore size is 0.22 μm. 4.3 Apparatus and equipment 4.3.1 Ultra high performance liquid chromatography-tandem mass spectrometer. charged electrospray ion source (ESI source). 4.3.2 Analytical balance. Sensitivity is 0.1 mg. 4.3.3 Centrifuge. speed ≥9000 r/min. 4.3.4 Vortex mixer. 4.3.5 Ultrasonic cleaner. 4.4 Analysis steps 4.4.1 Sample preparation 4.4.1.1 Liquid dosage form Weigh 0.2 g (accurate to 1 mg) of a well-mixed sample, place it in a 15 mL centrifuge tube, and add 10.0 μL of mixed internal standard compound standard Quasi-intermediate solution, add 3.0 mL methanol, vortex for 1 min to disperse the sample, ultrasonically extract for 10 min, add 0.15 g sodium chloride, vortex to mix, Centrifuge at 9000 r/min for 5 minutes, aspirate the supernatant, filter with a membrane, take 0.8 mL of filtrate into the sample bottle, add 0.2 mL of water, and mix well. For ultra performance liquid chromatography-tandem mass spectrometry determination. 4.4.1.2 Other dosage forms 4.4.1.2.1 Gel dosage form Weigh 0.2 g (accurate to 1 mg) of a well-mixed sample, place it in a 15 mL centrifuge tube, and add 10.0 μL of mixed internal standard compound standard Quasi-intermediate solution, add 3.0 mL acetonitrile, vortex for 1 min to disperse the sample, ultrasonically extract for 10 min, centrifuge at 9000 r/min for 5 min, and aspirate the supernatant Liquid, filter membrane, take 0.8 mL of filtrate into the sample bottle, then add 0.2 mL of water, mix well, for ultra performance liquid chromatography-tandem mass spectrometry determination. 4.4.1.2.2 Cream dosage form Weigh 0.2 g (accurate to 1 mg) of a well-mixed sample, place it in a 15 mL centrifuge tube, and add 10.0 μL of mixed internal standard compound standard Quasi-intermediate solution, add 3.0 mL methanol, vortex for 1 min to disperse the sample, ultrasonically extract for 10 min, centrifuge at 9000 r/min for 5 min, and aspirate the supernatant Liquid, filter membrane, take 0.8 mL of filtrate into the sample bottle, add 0.2 mL of water, mix well, for ultra-high performance liquid chromatography-tandem mass spectrometry determination. 4.4.2 Sample determination 4.4.2.1 Reference conditions for ultra performance liquid chromatography The reference conditions of ultra performance liquid chromatography are as follows. a) Chromatographic column. C18 column (column length 100mm, inner diameter 2.1mm, particle diameter 1.8μm), or equivalent; b) Mobile phase. Phase A is 0.1% formic acid aqueous solution, Phase B is acetonitrile; c) Flow rate. 0.3 mL/min; d) Column temperature. 40˚C; e) Injection volume. 5 μL; f) Gradient elution procedure. see Appendix B. 4.4.2.2 Mass spectrometry reference conditions The mass spectrometry reference conditions are as follows. a) Ionization method. ESI, ESI-scan at the same time; b) Ion source temperature. 550 ℃; c) Capillary voltage. ESI. 5.5 kV; ESI-. -4.5 kV; d) Curtain air. 2.1 × 105 Pa; e) Atomization gas. 4.5 × 105 Pa; f) Auxiliary gas. 4.5 × 105 Pa; g) Monitoring mode. multiple reaction monitoring (MRM) mode; h) Other mass spectrometry parameters. see Appendix C. 4.4.2.3 Preparation of standard curve The mixed standard series solutions were injected into the ultra performance liquid chromatography-tandem mass spectrometer in order from low to high concentration, and the corresponding peak surface was measured. The ratio of the quantitative ion peak area of the measured component to the quantitative ion peak area of the internal standard compound is compared with the corresponding mass concentration to make a standard curve. The sub-pair is qualitative, and the internal standard method is used for quantitative analysis. See Appendix D for the standard map. 4.4.2.4 Qualitative determination Under the same test conditions, the retention time of the target compound chromatographic peak in the sample is compared with the retention time of the corresponding standard chromatographic peak. The chemical range should be within ±2.5%, and the detected relative ion abundance should be consistent with the relative ion abundance in a standard solution of equivalent concentration. The relative abundance ratio deviation should meet the requirements of Table 1. Table 1 Maximum allowable deviation of relative ion abundance Relative ion abundance/% ＞50 ＞20～≤50 ＞10～≤20 ≤10 Allowable relative deviation/% ±20 ±25 ±30 ±50 4.4.2.5 Quantitative determination This method uses internal standard method for quantification. The ordinate is the ratio of the area of the quantitative ion peak of the measured component to the area of the quantitative ion of the internal standard compound (fourth Cyclin and chlortetracycline use tetracycline-D6 as internal standard, oxytetracycline uses oxytetracycline-C22-N2 as internal standard, and minocycline uses minocycline-D6 as internal standard. Doxycycline uses doxycycline-D3 as internal standard, erythromycin uses erythromycin-C-D3 as internal standard, cefradine uses cephalexin-D5 as internal standard, sulfa Pyrimidine uses sulfadiazine-D6 as internal standard, ofloxacin and norfloxacin uses levofloxacin-D8 as internal standard, clindamycin uses thiabendazole-D4 as internal standard Standard, chloramphenicol with chloramphenicol-D5 as the internal standard), and the abscissa is the mass concentration of the tested component in the sample. 4.4.2.6 Determination Inject the sample solution into the ultra-high performance liquid chromatography-tandem mass spectrometer for retention time and two pairs of ions (characteristic ion pair/quantitative ion pair) The relative abundance of the corresponding chromatographic peak area is qualitative, and the mass concentration of the target compound in the sample solution is calculated according to the standard curve. 4.4.3 Blank test Except that no sample is added, follow the steps in 4.4.1. 4.4.4 Calculation and expression of results The content of the target compound in the sample is calculated according to formula (1). 4.4.5 Precision The absolute difference between two independent determination results obtained under repeated conditions should not exceed 15% of the arithmetic mean. The recovery rate of this method And precision see Appendix E. 4.4.6 Detection limit and quantification limit When the sampling volume is 0.2 g and the extract volume is 3.0 mL, the detection limit and quantification limit of this method are shown in Appendix F.

5 Testing methods for other antibacterial drugs

It can be tested according to the method of "The Pharmacopoeia of People's Republic of China" For testing methods not covered by the Pharmacopoeia of the People's Republic of China, you can refer to the methods reported in the literature and be applied after verification.

6 Evaluation requirements

6.1 Antibacterial drugs should not be added to disinfectants and antibacterial agents. 6.2 Tetracycline, oxytetracycline, chlortetracycline, minocycline, doxycycline, erythromycin, cefradine, sulfonamide in disinfectants and antibacterial agents The content or total amount of pyrimidine, ofloxacin, norfloxacin, clindamycin, and chloramphenicol should not exceed 30 mg/kg. 6.3 The content or total amount of other antibacterial drugs in disinfectants and antibacterial agents should not exceed 1% of the minimum specification of external drugs. ......

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