Review & Monography

Regulations relevant to drug packing materials and research progress of analytical method of drug compatibility of pharmaceutical halobutyl rubber stoppers in our country

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  • 1. National Engineering Research Center for Synthesis of Novel Rubber and Plastic Materials, Yanshan Branch, Beijing Research Institute of Chemical Industry, SINOPEC, Beijing 102500, China;
    2. High-Tech Company Limited, Yanshan Petrochemical Company, SINOPEC, Beijing 102500, China;
    3. Synthetic Rubber Department, Yanshan Petrochemical Company, SINOPEC, Beijing 102503, China

Received date: 2021-07-15

  Online published: 2024-06-24

Abstract

The development of industry management regulations on immediate drug packing materials in China during the past 40 years was briefly overviewed. The upstream and downstream cooperation between drug manufacturers and rubber stoppers suppliers was tightened closely as drug and packing materials were bundled together for review and approval put into practice in the past two years which developed from earlier production licence and following registration approval after 2000. Drug compatibility studies and safety evaluation of drug packaging materials and drugs as necessary contents filled in drug marketing application were in line with the international standards. The common problems of compatibility of pharmaceutical halogenated butyl rubber stoppers in recent years were reviewed, including adsorption, extract and particle contamination, and the research progress of extraction and migration test analysis methods of volatile components, antioxidant and free sulfur, metal elements, silicone oil and non-volatile components in medical rubber plugs were summarized widely. It is of positive significance to improve the understanding of the effect of pharmaceutical rubber plug on drug quality and the safety in human health.

Cite this article

MENG Wei-juan, QIU Ying-xin, YU Pei-fu, QI Yu-hong, DENG Zheng-wei . Regulations relevant to drug packing materials and research progress of analytical method of drug compatibility of pharmaceutical halobutyl rubber stoppers in our country[J]. Chinese Journal of Pharmaceutical Analysis, 2021 , 41(11) : 1860 -1867 . DOI: 10.16155/j.0254-1793.2021.11.02

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