About This Service
AnalytiLab 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 USFDA, EMA, and other 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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