Solvias AG sell "Extractables & Leachables Testing"
Basic Information
954
75
17
4.5(27)
Category
Subcategory & Sub-subcategory
Trade Type
Sell
Service Name
Extractables & Leachables Testing
Service Provider(s)
Specifications
- Application: Extractables and leachables (E&L) testing service identifying chemical entities that may migrate from packaging, container-closure systems, or process equipment into drug products.
- Regulatory Status: Testing designed and executed per US FDA (USP <1663>/<1664>), EMA, ICH, and PQRI guidance for extractables and leachables studies.
- Certification Standard: Testing performed by an ISO/IEC 17025-accredited analytical laboratory.
Documents
FDA
GMP
ISO
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