Intertek Pharmaceutical Services sell "Extractables and Leachables Testing Services"
Basic Information
313
22
3
3.7(17)
Category
Subcategory & Sub-subcategory
Trade Type
Sell
Service Name
Extractables and Leachables Testing Services
Service Provider(s)
Specifications
- Extractables: Controlled extraction studies per USP <665>/<1663> using GC-MS, LC-MS, and ICP-MS techniques
- Leachables: Simulated clinical-use leachables studies per USP <1664> and region-specific EU/US/China guidance
- Barrier Properties: Container closure system risk assessment included as part of E&L method development scope
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