Several standards co-drafted by Shijiazhuang Sihua Pharmaceutical Group’s Bosheng Medical Devices have been incorporated into the new edition of the Chinese Pharmacopoeia.
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发布时间:2025-04-30
【概要描述】
The 2025 Edition of the Pharmacopoeia of the People’s Republic of China (hereinafter referred to as the “Chinese Pharmacopoeia”) will come into effect on October 1, 2025. Notably, it includes the “Guiding Principles for Rubber Seals Used in Pharmaceutical Packaging” (No. 9623), as well as five method standards—“Method for the Examination of Volatile Sulfur Compounds in Rubber Seals” (No. 4219), “Method for the Determination of Ash Content in Rubber Seals” (No. 4220), “Method for the Determination of Moisture in Rubber Seals” (No. 4221), “Method for the Determination of Surface Silicone Oil Content in Rubber Seals” (No. 4222), and “Method for the Examination of Specific Residues in Silicone Rubber Seals” (No. 4223)—which were jointly developed with the participation of Jiangsu Bosheng Medical New Materials Co., Ltd. of the Group. As a…
The 2025 Edition of the Pharmacopoeia of the People’s Republic of China (hereinafter referred to as the “Chinese Pharmacopoeia”) will come into effect on October 1, 2025. This edition includes five method standards—“Guiding Principles for Rubber Seals Used in Pharmaceutical Packaging” (No. 9623), “Test Method for Volatile Sulfur Compounds in Rubber Seals” (No. 4219), “Determination of Ash Content in Rubber Seals” (No. 4220), “Determination of Moisture in Rubber Seals” (No. 4221), “Determination of Surface Silicone Oil Content in Rubber Seals” (No. 4222), and “Test Method for Specific Residues in Silicone Rubber Seals” (No. 4223)—which were jointly developed with the participation of Jiangsu Bosheng Medical New Materials Co., Ltd. As the only pharmaceutical packaging materials company in China to have taken part in drafting these standards, Bosheng Medical New Materials’ comprehensive strengths in R&D, manufacturing, and quality control have thus been officially recognized by authoritative bodies. As an essential component of pharmaceutical products, pharmaceutical packaging materials accompany the entire lifecycle of drug production, distribution, and use. Their quality directly impacts the safety and efficacy of medicines and is critical to public medication safety. As a member of the Pharmaceutical Rubber Stopper Professional Committee of the China Pharmaceutical Packaging Association and a leading enterprise in the domestic pharmaceutical packaging industry, Bosheng Medical Materials consistently focuses on the development of key technologies for pharmaceutical packaging materials and the pharmaceutical sector. The company actively aligns with international advanced standards, has repeatedly chaired or participated in the formulation of national and industry standards, and has been granted more than 100 patents, thereby becoming a vital driving force in advancing and elevating the standardization of pharmaceutical packaging materials.
In recent years, Bosheng Medical Materials has consistently been driven by innovation, leveraging its “industry–university–research–application” innovation model to accelerate technological self-reliance and strength. The company has continuously enhanced the synergistic effects of its “one institute, two business units” structure, focusing on the R&D and manufacturing of novel pharmaceutical packaging materials. It has steadily advanced new-product development and technological upgrades, resulting in a diversified portfolio of pharmaceutical packaging products, including pharmaceutical rubber stoppers and medical infusion films. All of its products meet internal control standards that comprehensively exceed national industry standards, with some even capable of replacing imports and achieving domestic substitution. As a result, Bosheng has gradually grown into a high-quality supplier of products and solutions for the pharmaceutical packaging industry.
The Chinese Pharmacopoeia is an essential component of the national pharmaceutical standards and serves as the statutory technical standard that all relevant entities— including those engaged in drug research and development, manufacturing (including importation), distribution, clinical use, and regulatory oversight— are required to comply with. On March 20, 2025, the National Medical Products Administration and the National Health Commission issued an announcement stating that, in accordance with the Drug Administration Law of the People’s Republic of China, the 2025 Edition of the Chinese Pharmacopoeia has been reviewed and approved at the plenary meeting of the Executive Committee of the 12th Pharmacopoeia Commission and is hereby promulgated, effective October 1, 2025.
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