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您的位置 : 橡膠密封件 > 综合色姑娘動態 > 密封件慎用的添加劑種類及參考資料

密封件慎用的添加劑種類及參考資料

时间 : 2019-03-16 20:00:01 浏览量 : 15

8. 附件


密封件慎用的添加劑種類

商品名稱

化學名稱或可能含有的物質

CAS #

可能産生的風險物質

補白

硫化劑及硫化促進劑

Diak 1#

六亞甲基二胺氨基甲酸鹽

143-06-6

有毒


促進劑M

(2-MBT)

2-巯基苯並噻唑

149-30-4

亞硝胺


促進劑DM

2,2'-二硫代二苯並噻唑

120-78-5

分解成2-巯基苯並噻唑


硫化劑HVA-2

N,N-間苯撐雙馬來酰亞胺

3006-93-7

有致癌性


促進劑BZ

二正丁基二硫代氨基甲酸鋅

136-23-2

亞硝胺类化合物


促進劑EZ

二乙基二硫代氨基甲酸鋅

136-94-7

亞硝胺类化合物


促進劑PZ

二甲基二硫代氨基甲酸鋅

137-30-4

亞硝胺类化合物


促進劑DTDM

4,4,-二硫代二嗎啉

103-34-4

有毒


促進劑TT

二硫代四甲基秋蘭姆

137-26-8

易喷出、挥发性亞硝胺


其他

爐法炭黑

C

1333-86-4

含多環芳烴類物質



9. 参考资料


1)化學藥品注射劑與塑料包裝材料相容性研究技術輔導准則(試行)(國食藥監注〔2012〕267號)

2)化學藥品注射劑與藥用玻璃包裝容器相容性研究技術輔導准則(試行)(國家食品藥品監督管理總局布告2015年第40號)

3)《中国人民共和国药典》2015年版 公例9621、9622

4)YBB00142002-2015藥品包裝材料與藥物相容性實驗輔導准則

5)ICH M7 (R1) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.

6)ICH Q3D Guideline for Elemental Impurities.

7)EMEA Guideline on Plastic Immediate Packaging Materials. (2005)

8)European Pharmacopoeia (Ph.Eur) Chapter 3 “Materials and Containers”.

9)United States Pharmacopeia (USP) Chapter 87, 88, 381, 1381, 1663, 1664.

10)Safety Thresholds and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products, PQRI Leachables and Extractables Working Group. (2006)

11)Comprehensive Determination of Extractables from Five Different Brands of Stoppers Used for Injectable Products. PDA Journal of Pharmaceutical Science and Technology 2009, 63 527-536.

12)Experimental Protocol for Qualitative Controlled Extraction Studies on Material Test Articles Representative of Prefilled Syringe (PFS) and Small Volume Parenteral (SVP) Container Closure Systems. PQRI Parenteral and Ophthalmic Drug Products Leachables and Extractables Working Group.(2011)

13)Perspectives on the PQRI Extractables and Leachables ''Safety Thresholds and Best Practices'' Recommendations for Inhalation Drug Products. PDA Journal of Pharmaceutical Science and Technology 2013, 67 413-429.

14)The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product (PODP) . PDA Journal of Pharmaceutical Science and Technology 2013, 67 430-447.

15)Extractables Characterization for Five Materials of Construction Representative of Packaging Systems Used for Parenteral and Ophthalmic Drug Products. PDA Journal of Pharmaceutical Science and Technology 2013, 67 448-511.

16)Simulated Leaching (Migration) Study for a Model Container-closure System Applicable to Parenteral and Ophthalmic Drug Products (PODPs). PDA Journal of Pharmaceutical Science and Technology 2016, 70 1-46.

17)Jenke, D. Compatibility of Pharmaceutical Products and Contact Materials. Safety Considerations Associated with Extractables and Leachables. Hoboken, NJ. John Wiley & Sons. 2009.

18)Ball, Douglas J., Norwood, Daniel L., Stults, Cheryl L.M., Nagao, Lee M., ed.

Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products. Hoboken, NJ. John Wiley & Sons. 2012.












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