About This Service
Jarvogen is a specialized center for Extractable and Leachable (E&L) studies, having completed over 2,000 studies for pharmaceutical packaging systems. Our E&L studies assess the safety of drug-container closure interactions for parenteral, inhalation, ophthalmic, and oral dosage forms. Our data has been accepted by global regulatory agencies.
Key Information
Accredited by
What's Included
Instruments Used
LCMS/MS (Triple Quadrupole)
Non-volatile organic extractables and leachables
GC-MS / GC-FID
Volatile and semi-volatile organic compounds
ICP-MS
Elemental extractables and leachables
ICP-OES
Multi-element screening of extractables
Regulatory Standards
How We Work
Scope & Risk Assessment
Packaging materials identified, risk assessment performed, AET and SCT calculated.
Extraction Studies
Controlled extraction using multiple solvents; exhaustive and simulated-use extractions.
Analytical Testing
LCMS/MS, GC-MS, ICP-MS screening; compound identification and quantification.
Safety Assessment & Report
TTC-based safety evaluation; comprehensive E&L report for regulatory submission.
Ready to Start Your Extractable & Leachable (E&L) Studies?
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