Extractables & Leachables (영문)
- 최초 등록일
- 2020.12.30
- 최종 저작일
- 2019.01
- 27페이지/ MS 파워포인트
- 가격 1,500원
소개글
"Extractables & Leachables (영문)"에 대한 내용입니다.
목차
1. Overview on E&L
2. Extractable assessment
3. Toxicology assessment
4. Leachable assessment
본문내용
1. Overview on E&L
What are extractables and leachables?
Organic and inorganic chemical entities that…
Extractable
could migrate
by using simulating solvents
at laboratory conditions
Leachable
actually migrate
by testing as drug product
at real storage condition
Currently available regulations
EMEA Guideline on plastic immediate packaging materials CPMP/QWP/4659/03 EMEA/CVMP/205/04
EMEA Guideline on the limit of genotoxic impurities CPMP/SWP/5199/02 EMEA/CHMP/QWP/251644/2006
USP <1663> Assessment of extractables associated with pharmaceutical packaging/deliver systems
USP <1664> Assessment of drug product leachables associated with pharmaceutical packaging/delivery systems
USP <1664.1> Orally inhaled and nasal drug products
FDA Guidance for Industry Container closure for Packaging Human Drugs and Biologics (1999)
USP <661.2> Containers-Plastic
USP <381> elastomeric closures for injection
EP Chapter 3.1 Material used for the manufacture of containers
EP Chapter 3.2 Containers
참고 자료
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