GB/T 31063-2014

Active

Extracables in aqueous autoclavates for pharmaceutical closures of butyl rubber

丁基橡胶药用瓶塞高压水溶出物

Standard Type
GBT
ICS
83.140.01
CCS
G40
Status
Active
Issue Date
2014-12-22
Implementation
2015-06-01
Centralized Committee
中国石油和化学工业联合会
Issuing Authority
中国石油和化学工业联合会

Application Summary AI generated

This standard specifies the method for determining the amount of water-extractable substances released from butyl rubber pharmaceutical closures when subjected to high-pressure steam sterilization (autoclaving). It is applied in the pharmaceutical industry to evaluate the chemical purity and safety of rubber stoppers, seals, and other closures used for drug packaging, ensuring they do not contaminate injectable or liquid medications during sterilization.

Related Standards

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.