T/UNP 744-2025 General Technical Requirements for Agarose Chromatography Media

Scope

Main technical content: This standard provides the product classification of agarose chromatography media, stipulates its basic requirements, material requirements, appearance requirements, performance requirements, safety requirements, environmental protection requirements, as well as marking, labeling, packaging, transportation, and storage, etc., which is suitable for the design and production of chromatography media with agarose as the main matrix. Among them, the products are divided into cross-linked agarose chromatography media and high-rigidity agarose chromatography media according to the pressure resistance characteristics; in terms of materials, there are clear requirements for ethanol content and agarose purity; appearance requirements include a full spherical shape and a smooth surface; performance requirements cover physical properties (such as average particle size and maximum flow rate), chemical properties (such as 5-hydroxymethylfurfural release amount), and biological properties (such as total colony count and endotoxin content); safety requirements include the absence of known human pathogens, acute oral toxicity, and limits on heavy metals; environmental protection requirements involve waste disposal and pollutant emissions that must comply with relevant standards; at the same time, regulations are also made for marking and labeling, packaging, transportation, and storage conditions.

Development Information

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