T/FDSA 0058-2024 Active Group standards

T/FDSA 0058-2024 mRNA vaccine and drug quantification of dsRNA impurity using ELISA method

Publish Date: 2024-11-15 Implement Date: 2024-12-15 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/FDSA 0058-2024

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Drugs

Publish Date: 2024-11-15

Implement Date: 2024-12-15

Scope

Main technical content: This document specifies the principles of ELISA method for detecting dsRNA impurities in mRNA vaccines and drugs, the selection of standard substances and antibodies, reagent materials, ELISA method validation, ELISA detection process, and data analysis. This document is applicable to the determination of dsRNA impurities in mRNA vaccines and drugs based on the ELISA method.