GB/T 41309-2022 in English

VALID

Nanotechnologies—Endotoxin test on nanomaterial samples for in vitrosystems—Limulus amebocyte lysate (LAL) test

Issued on:2022-03-09
Implemented on:2022-10-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $270.00
$262.00

Standard No:	GB/T 41309-2022
Document status:	VALID
Title in English:	Nanotechnologies—Endotoxin test on nanomaterial samples for in vitrosystems—Limulus amebocyte lysate (LAL) test
Title in Chinese:	纳米技术纳米材料的内毒素体外测试鲎试剂法
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2022-03-09
Implemented on:	2022-10-01
ICS Classification:	07.030-Physics. Chemistry
Chinese Classification:	C04-Basic standards and general methods
Professional Classification:	GB-National Standard
Related Keywords:	vitrosystems limulus amebocyte lysate nanotechnologies endotoxin test amebocyte lysate test introduction interpretation endotoxin contamination
Related Topics:	Nano nanotechnology nanomaterials Nano Flow Detection Nano gold UV Gold Nano UV in vitro testing Nanomaterials Laboratory Nanomaterials Research laboratory nanomaterials Nano gold UV Nanomaterials and Technology Nanomaterials Laboratory nanoparticle toxin Gold Nano UV Peak Nano gold UV peak Nano gold UV peak nanomaterial infrared UV nano metal UV nano silver Silver Nano UV nanomaterials Gold Nano UV Coefficient Gold Nano UV Detection endotoxin Gold Nano UV Detection Inkjet Nanomaterials Nano gold carrier a nanometer Nano gold UV nanoengineered materials Nano reagent exosome nano nanogram reagent Toxicity of metal nanoparticles nanomaterials Nessler's reagent test method UV peak of gold nanoparticles nanoengineered materials Reagent method Toxin test Limulus reagent nanogram reagent Exosome Nano Methods for detecting the structure of nanomaterials Determination of endotoxin by reagent method Infrared of Nano Ruthenium Phases of Nanomaterials European Nanomaterials Nanomaterials for the first time Toxin Limulus Reagent Method nanomaterials and me lal's reagent lal reagent water in nanotubes Nanomaterial Analysis Spectroscopic Measurements of Nanomaterials Material Nano Nanomaterials and Products Tellurium Nanomaterials Nano gold UV wavelength nanomaterials and nano test material element Nanomaterials mtt Material toxins Angstrom to nanometer conversion Carrier gold nanoparticles Toxins in the body nanomaterial phase In vitro/be True Density Nanomaterials Choice of Limulus Reagent Infrared peaks of gold nanoparticles Detection of endotoxin nano exosomes test reagent Nano carbon agent Future Nanomaterials Gold Nanomaterials Spectra Gold Nanomaterials + Spectroscopy nano silver UV Endotoxin determination and Limulus test Limulus reagent conditions Nanomaterials Engineering Nano material motor semi-nanometer material "nanotechnology Materials Nanotechnology Nano multi-element cobalt nanomaterials Photometric Limulus Reagent Limulus test principle Domestic Nanopore Materials Testing Technology lal endotoxin test tube reagent Gold Nano UV Peak GBT41309 GB/T 41309-2022 Molecular Materials \| Nanomaterials \| Nanochemistry Nano\|Inorganic Nano\|Optoelectronic Nanomaterials\|Nanochemistry\|Nanotechnology\|Nanomaterials\|Nanostructures\|Catalysts\|Catalysis\|Catalytic Materials\|Fluid Mixing Limulus reagent Illumina instrument testing reagents Limulus reagent quantitative detection method Scientists in the field of nanomaterials Nanomaterial tracer UV measurement of nanomaterials UV measurement standard for nanometer copper oxide materials nanopore group Limulus reagent method is the gold standard for endotoxin detection How to prepare Nessler's reagent Bacterial endotoxin limulus reagent test method Limulus reagent interference test method Far infrared nanopowder Limulus reagent method for detection of endotoxin Limulus reagent endotoxin detection method experimental steps Limulus reagent bacterial endotoxin detection method How to use lysate test Limulus reagent method for detecting endotoxin Limulus reagent quality Nanomaterial testing Standard curve Nessler's reagent method Nanomaterials and Technologies gb/t 41309-2022

《GB/T 41309-2022纳米技术纳米材料的内毒素体外测试鲎试剂法》由TC279（全国纳米技术标准化技术委员会）归口，主管部门为中国科学院。

Introduction

Interpretation of the core content of the standard

This standard is equivalent to ISO29701:2010, and specifies the technical requirements for the use of Limulus amebocyte lysate (LAL) to detect endotoxin contamination in nanomaterials. It is mainly applicable to the quality control of water-dispersible systems and non-intestinal nanomaterials.

Key Technical Requirements

Detection Method	Sensitivity(EU/mL)	Applicable Scenarios	Interference Factors
Gel Method	0.015	Basic Screening	Salts, Metal Ions
Endpoint Colorimetric Method	0.001-0.01	Precise Quantification	Colorimetric Interference
Dynamic Method	0.001	High Sensitivity Detection	Turbidity interference

Key implementation points

Sample processing specifications

1. The container needs to be depyrogenated at 250℃ 30min
2. Endotoxin-free polystyrene containers are recommended
3. The operating environment must reach ISO5 cleanliness level

Interference control strategy

• Salt concentration adjustment: Use TRIS buffer to control pH 6-8
• Metal ion interference: Add EDTA-Na
• β-glucan interference: Use specific LAL reagent

Standard technology evolution

This standard converts ISO29701 into a national standard for the first time. The main technical breakthroughs are:

New chapter on normative references
Specify special processing requirements for nanomaterials
Refine interference control indicators

Application Cases

When a carbon nanotube production company used dynamic method detection:
1. Initial detection value was abnormal → polypropylene container interference was found
2. After switching to glass container → detection value met the ＜0.005EU/mg standard
3. Improving extraction efficiency by adding 0.1% vitamin E surfactant

More samples: JJG 21-2008 JC/T 2453-2018 GB 18306-2015

Sample only — not a preview of GB/T 41309-2022

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