T/ZZB 2492-2021 Active Group standards

T/ZZB 2492-2021 Enteric-coated gelatin capsules with hollow shell

Publish Date: 2021-09-08 Implement Date: 2021-10-08 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/ZZB 2492-2021

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: The excipients used in pharmaceutical preparations and other substances

ICS Name: Medical materials

Publish Date: 2021-09-08

Implement Date: 2021-10-08

Scope

Main technical content: This document specifies the basic requirements, technical requirements, test methods, inspection rules, marking, packaging, transportation and storage, and quality commitments for coated enteric-coated gelatin hollow capsules (hereinafter referred to as "capsules"). This document is applicable to coated enteric-coated gelatin hollow capsules made by using capsule gelatin and additives with a three-layer coating process. This document is not applicable to colon-enteric-coated capsules.