WS/T 684-2020 in English

VALID

Analytical method and evaluation requirements for antibacterial drugs in disinfectant and antibacterial and bacteriostatic agents

Issued on:2020-07-20
Implemented on:2021-02-01
File Format:PDF
Delivery:Via email within 5 business days

Price(USD)： $310.00
$301.00

Standard No:	WS/T 684-2020
Document status:	VALID
Title in English:	Analytical method and evaluation requirements for antibacterial drugs in disinfectant and antibacterial and bacteriostatic agents
Title in Chinese:	消毒剂与抗抑菌剂中抗菌药物检测方法与评价要求
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 5 business days
Issued on:	2020-07-20
Implemented on:	2021-02-01
ICS Classification:	11.080-Sterilization and disinfection
Chinese Classification:	C50-Sanitation in general
Professional Classification:	WS-Hygiene
Related Keywords:	standard detection category representative drugs pretreatment method limit antibacterial drugs internal standard method analytical method unified detection method
Related Topics:	drug testing antibacterial Antibacterial detection Antibacterial detection drug in english Bacteriostat Disinfectant testing agency Antibacterial detection Neutralizing antibody detection method Neutralizing antibody detection method Antibacterial detection Antioxidant detection method new antibacterial drugs Primary antibody detection and secondary antibody detection antibacterial drugs Detect neutralizing antibody method antibacterial agent drug detection method Detection method of neutralizing antibody drug testing Antioxidant detection method Neutralizing antibodies and detection antibodies zone of inhibition method drug method new antimicrobials Pesticide detection and detection method Liquid agent detection method zone of inhibition method new antibacterial drugs Evaluation of detection methods antibacterial drugs Antibacterial Broad-spectrum antibacterial detection Double Antibody Disinfection Antibacterial Pesticides Evaluation of detection methods Antibacterial Standard Broad Spectrum Antimicrobials Antibacterial Pesticides Non-antibacterial method medicine super antimicrobial Neutralizing antibodies and primary antibodies Oxybromide antibacterial agent Drug detection method drug detection method Neutralizing antibody detection method Inhibition Zone Determination Method Pharmaceutical dosage form Neutralizing antibodies and general antibodies neutralizing antibody assay Neutralizing and non-neutralizing antibodies antibacterial drugs Antibodies vs Neutralizing Antibodies regenerative antimicrobial Microbial Disinfection and Sterilization Antimicrobial Screening Methods Antimicrobial Screening Methods Detection of disinfectants in water Chinese medicinal materials, traditional Chinese medicine raw materials (auxiliary) materials and preparations Commonly used bacteriostatic agents for injections Methods for detecting in vitro inhibition of anticancer drugs Chinese Pharmacopoeia bacterial endotoxin detection method Long-lasting antibacterial testing Dosage of bacteriostatic ointment Sterile animal testing methods Methods and procedures for fungal microscopy Antiviral drug testing methods Detection method of silver ion antibacterial coating Inhibitor detection methods Methods to detect antibody titer Methods for determining the quality of bacterial agents Antibody titer detection method Method for detecting bacterial toxoid using shark reagent Pharmacopoeia method for acid value detection Antiviral drug determination methods Methods for sterility testing to eliminate bacteriostasis Methods for detecting foreign matter in sterile raw materials Monoclonal antibody titer detection method Methodological evaluation of antinuclear antibodies Neutralizing antibody titer detection method Methods of Disinfection and Sterilization High School Biology Animal administration routes and methods Tablet testing methods Anti-botulinum toxin antibody detection method Cryptococcal antigen detection method

本标准规定了消毒剂与抗抑菌剂中抗菌药物的检测方法和评价要求。
本标准适用于消毒剂与抗抑菌剂中四环素类（四环素、土霉素、金霉素、米诺环素、强力霉素）、大环内酯类（红霉素）、β-内酰胺类（头孢拉定）、磺胺类（磺胺嘧啶）、喹诺酮类（氧氟沙星、诺氟沙星）、林可酰胺类（克林霉素）、氯霉素类（氯霉素）及其它抗菌药物的测定和评价。

Introduction

Analysis of the core content of the standard

Detection category	Representative drugs	Pretreatment method	Limit of quantification (μg/kg)
Tetracyclines	Tetracycline, chlortetracycline	Methanol ultrasonic extraction	15-45
Macrolides	Erythromycin	Acetonitrile extraction (gel)	6
Quinolones	Ofloxacin	Methanol water solution dilution	5-15

Detailed explanation of technical points

Chromatographic mass spectrometry conditions

Use C18 chromatographic column (1.8μm) for gradient elution and ESI positive and negative ion simultaneous scanning mode. For detailed parameters, see Appendix BC. Key mass spectrometry parameters:

Ion source temperature: 550℃
Capillary voltage: ±4.5-5.5kV
Curtain gas pressure: 2.1×10⁵ Pa

Implementation suggestions

Laboratory preparation requirements

Standards need to be stored at -20℃. Pay attention to the validity period (3 months for stock solution and 1 month for intermediate solution)
Different dosage forms use different pretreatments: liquid dosage forms are centrifuged with chloride salt, and gel dosage forms are extracted with acetonitrile
Blank test and spike recovery are required for each batch of testing (control range 70-120%)

Standard evolution analysis

This standard establishes a unified detection method for 12 types of antimicrobial drugs in disinfection products for the first time. Compared with the pharmacopoeia method:

The detection limit is reduced by 50-80% (e.g. erythromycin is reduced from 15μg/kg to 6μg/kg)
The isotope internal standard method is introduced to improve accuracy
The limit threshold of 30mg/kg is clarified

More samples: NB/T 47013.2-2015 DL/T 5154-2012 QC/T 942-2021

Sample only — not a preview of WS/T 684-2020

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