T/ZJYBF 0005-2004 Active Group standards

T/ZJYBF 0005-2004 Oral dosage formulation packaging polyethylene terephthalate (PET) resin

Publish Date: 2024-06-11 Implement Date: 2024-06-11 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/ZJYBF 0005-2004

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Medical materials

Publish Date: 2024-06-11

Implement Date: 2024-06-11

Scope

Main technical content: Polyethylene terephthalate (PET) resin has broad market prospects and application potential. Due to its excellent safety, physical properties, economy, and recyclability, it has been widely used in the fields of chemical fiber, food packaging, drug (non-injection) packaging, and medical devices (such as blood collection tubes). During the drafting of this document, we mainly refer to the United States Pharmacopeia (USP) <661> "Plastic Packaging Systems and Their Component Materials" and the European Pharmacopeia (EP) 3.1.15 "Polyethylene Terephthalate Materials for Non-Injection Preparation Containers", and propose technical requirements for the identification of PET resin used in oral preparation packaging, including the appearance of the extract solution, the pH of the extract solution, the absorbance of the extract solution, the reducing substances in the extract solution, the dichlorodimethylsilane solubles, the eight metal contents in the extract solution, and the sulfate ash. In addition, we refer to the "Selected Pharmacopoeia Standards for Pharmaceutical Packaging Materials in Europe, America, and Japan" compiled by the National Pharmacopoeia Committee and the China Pharmaceutical Packaging Association, and provide relevant informational appendices.