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GB/T 41309-2022Nanotechnologies - Endotoxin test on nanomaterial samples for in vitrosystems - Limulus amebocyte lysate (LAL) test (English PDF)

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Issued by

State Administration for Market Regulation, China National Standardization Administration

Level / Type

National · Recommended

Issue date

March 9, 2022

Implementation date

October 1, 2022

Scope

GB/T 41309-2022 (Nanotechnologies - Endotoxin test on nanomaterial samples for in vitrosystems - Limulus amebocyte lysate (LAL) test) is available as an English-translated PDF.

GB/T 41309-2022 is the Chinese standard "Nanotechnologies - Endotoxin test on nanomaterial samples for in vitrosystems - Limulus amebocyte lysate (LAL) test". Its scope clause reads: This document describes the application of the Limulus assay (LAL) to evaluate the endotoxin levels of nanomaterials for in vitro biosystem applications.

The test party The method is suitable for the detection of nanomaterials dispersed in aqueous solutions such as water, serum or reaction solution, and these media can be incubated with nanomaterials at 37 °C a certain time.

This document is applicable to the detection of in vitro samples, and these methods are also applicable to the application of nanomaterials to animals by parenteral routes. Material. Its clauses include terms and definitions.

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Document preview — GB/T 41309-2022

National Standard of the People's Republic of China

Classification: C 04

Issued by: State Administration for Market Regulation, China National Standardization Administration

Introduction
1 Scope
2 Normative references

1 Scope

This document describes the application of the Limulus assay (LAL) to evaluate the endotoxin levels of nanomaterials for in vitro biosystem applications. The test party

The method is suitable for the detection of nanomaterials dispersed in aqueous solutions such as water, serum or reaction solution, and these media can be incubated with nanomaterials at 37 °C a certain time.

This document is applicable to the detection of in vitro samples, and these methods are also applicable to the application of nanomaterials to animals by parenteral routes.

Material.

2 Normative references

There are no normative references in this document.

3 Terms and Definitions

The following terms and definitions apply to this document.

3.1 coagulogen

The coagulable protein in the LAL reagent plays a primary role in gel formation caused by endotoxin.

3.2 coagulin

Coagulation protein is digested by coagulation protease in LAL reagent.

47-Phenylalanine 175) (see reference [7]).

3.3 endotoxin

Part of the outer component of the cell wall of Gram-negative bacteria.

NOTE. The main active ingredient is lipopolysaccharide (LPS).

3.4 endotoxinunit

EU Standard unit of endotoxin activity.

Note 1.According to the definition of endotoxin unit formulated by the World Health Organization (WHO) Expert Committee on Biological Standardization (ECBS) in.1996, 0.1ng of Escherichia coli

The 0113.HK10.K(-)-derived WHO Reference Standard for Endotoxin (RSE) has an activity of 10 EU/ng (see reference [8]).

Note 2.EU is equivalent to the International Unit (IU) of endotoxin.

3.5 lambda

GB/T 36388 | YBB 2027 | YBB 6006 | GB/T 46333 | GB/T 45633 | […]

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 34 pages — is available in the English PDF.

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