GB/T 38093-2019

Active

Determination of the high-molecular polymers in β-lactam antibiotics—Gel chromatography

β-内酰胺类抗生素高分子聚合物测定凝胶色谱法

Standard Type

GBT

ICS

07.080

CCS

A21

Status

Active

Issue Date

2019-10-18

Implementation

2019-10-18

Centralized Committee

国家标准委

Issuing Authority

国家市场监督管理总局、中国国家标准化管理委员会

Application Summary AI generated

This standard specifies a gel chromatography method for determining high-molecular polymer content in β-lactam antibiotics. It is applied in pharmaceutical quality control and testing laboratories to ensure the safety and purity of antibiotic products such as penicillins and cephalosporins. The method helps detect potentially immunogenic polymer impurities that can cause allergic reactions in patients.

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Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.