Disclaimer 声明
n The content of this prentation reprents the opinions of Edward J. Smith and Packaging Science Resources, LLC alone and not necessarily tho of the PRQI, PDA, or any other organization with which he is affiliated.ppln>墨子怎么玩
n本报告中的观点仅代表我个人和公司。不代表我加入的PRQI、PDA以及其它协会。
军训心得体会大学2
Prentation Outline报告提纲
I. Best Extractables and Leachables (E&L) Practices for Large
Volume Parenterals (LVPs)大容量输液（LVPs）的可提取物和浸出物
（E&L)的最佳实践
-Guidance from the Pharmaceutical Quality Rearch Institute (PQRI)药品质量研究所的指导原则
II. The Role of E&L Studies in Demonstrating Compatibility E&L研究在相容性研究中的作用
III. E&L Details可提取物和可浸出物细节
a. Relationship between Extractables and Additives可提取物和添加剂的关系
b. Validation of Methods for E&L Tests E&L测试的方法验证
c. Extractables Tests vs. Tests to Determine Material Composition可
提取物测试和决定材料组成
IV. Summary and Discussion总结和讨论
3
Prentation Outline报告提纲
I. Best Extractables and Leachables (E&L) Practices for
Large Volume Parenterals (LVPs)
-Guidance from the Pharmaceutical Quality Rearch
Institute (PQRI)
I大容量输液（LVPs）的可提取物和浸出物（E&L)的最佳实践
－药品质量研究所的指导原则
II. The Role of E&L Studies in Demonstrating
谢燮Compatibility
III. E&L Details红包怎么做手工
质量要求a. Relationship between Extractables and Additives
b. Validation of Methods for E&L Tests
c. Extractables Tests vs. Tests to Determine Material
Composition
4
别什么一格
Extractables vs. Leachables
可提取物和可浸出物
n Extractables -chemical components that are removed from a material by exertion of an artificial or exaggerated force
可提取物——材料被人工的或扩大的外力所能提取出的化学物质-Force = solvent, temperature, time外力＝溶剂、温度、时间
-Extractables »Material/Component Test 可提取物»材料/组分测试
n Leachables -chemical components that migrate from a contact material into drug products during storage at “normal”conditions
可浸出物－在常规贮存条件下，材料与药品接触后可迁出的化学物质
-Leachables »Drug Product Test 可浸出物»药品测试
Leachables are usually a subt of extractables.
长效避孕药的副作用
可浸出物通常是可提取物的一部分。
5
Summary…总结
n AET is applied to Extractables & Simulation Studies…NOT
Leachables Studies AET适合于可提取物模拟研究……不适合于可浸出物研究
n There are no “accepted”SCTs for injectables such as LVPs; SCT for OINDP = 0.15 µg/day 对于注射剂没有可接受的SCTs，口服吸入制剂的SCT = 0.15 µg/day
n AETs calc. from an SCT equal to 0.15 µg/day, are very low for LVPs…frequently too low to measure.注射制剂从SCT计算得到的AET太低……通常很难测量
n Alternative SCTs for injectables are being discusd by
PQRI…no official SCTs yet published. PQRI正在讨论可替代的注射制剂的SCTs……官方SCTs尚未出版
n Simulation Studies are required to obtain “probable leachables”
from LVP products.注射制剂的可能浸出物从模拟研究中得到
6
