GB/T 31063-2014 Active National standards

GB/T 31063-2014 Extracables in aqueous autoclavates for pharmaceutical closures of butyl rubber

Publish Date: 2014-12-22 Implement Date: 2015-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 31063-2014

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Rubber products and their auxiliary materials

ICS Name: Comprehensive products made from rubber and plastic

Publish Date: 2014-12-22

Implement Date: 2015-06-01

Pages: 18 pages

Scope

1.1 This standard specifies the chemical requirements and test methods for the high-pressure water extractables of pharmaceutical stoppers made primarily from butyl rubber. The performance requirements specified in this standard are the minimum requirements for the high-pressure water extractables of butyl rubber pharmaceutical stoppers (hereinafter referred to as stoppers).
1.2 This standard does not specify the steps for the compatibility study of stoppers with the intended pharmaceuticals.
1.3 This standard applies to butyl rubber pharmaceutical stoppers.