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Special Studies Discipline
FDCA Form 37 Approved21 CFR Part 11 Compliant
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Extractable & Leachable (E&L) Studies

Assessment of drug-container interactions using LCMS/MS, GCMS, and ICPMS. Data accepted by US & EU regulators.

E&LLCMS/MSGCMSPackaging
Regulatory AcceptanceUSFDA, EMA, PMDA
Dosage FormsParenteral, Inhalation, Ophthalmic, Oral
Turnaround Time30–60 working days
● Lab Capacity ActiveForm 37 Certified

Study Protocol Support

Direct access to analytical specialists for study design, method validation, and turnaround timelines.

Submit Sample MatrixDownload Service Spec Sheet
Direct Technical Desk:+91 76240 54108
Service Scope & Regulatory Framework

Rigorous Scientific Execution Built for Global Regulatory Dossiers

Jarvogen is a specialized center for Extractable and Leachable (E&L) 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.

Compendial Standards & Regulatory Alignment:
✓ USP <1663>✓ USP <1664>✓ ICH Q3E✓ BioPhorum✓ PQRI
Dual-Analyst Review

100% 4-eye verification of all chromatograms, integrations, and calculations before CoA generation.

ALCOA+ Data Integrity

Direct electronic data capture with immutable audit trails, restricted rights, and disaster backups.

Technical SpecificationscGLP Compliant

Regulatory AcceptanceUSFDA, EMA, PMDA
Dosage FormsParenteral, Inhalation, Ophthalmic, Oral
Turnaround Time30–60 working days
Quality Credentials
FDCA Gujarat Form 37ICH Compliant (Q1–Q14)21 CFR Part 11
Key Analytical Capabilities

What's Covered in the Testing Scope

Comprehensive assay, stability, and characterization endpoints validated to global pharmacopoeial standards.

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Extractables screening (organic and inorganic)Executed with validated SOPs and full raw data audit trails.
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Leachables monitoring in drug productExecuted with validated SOPs and full raw data audit trails.
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Threshold of Toxicological Concern (TTC) assessmentExecuted with validated SOPs and full raw data audit trails.
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Safety concern threshold (SCT) evaluationExecuted with validated SOPs and full raw data audit trails.
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Analytical evaluation threshold (AET) calculationExecuted with validated SOPs and full raw data audit trails.
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Container closure integrity testingExecuted with validated SOPs and full raw data audit trails.
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Packaging material characterizationExecuted with validated SOPs and full raw data audit trails.
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Risk assessment and safety evaluationExecuted with validated SOPs and full raw data audit trails.
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Regulatory submission support (USFDA, EMA)Executed with validated SOPs and full raw data audit trails.
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Studies for parenteral, inhalation, ophthalmic dosage formsExecuted with validated SOPs and full raw data audit trails.
Qualified Laboratory Infrastructure

Validated Instrumentation & Data Systems

All instruments operate with full IQ/OQ/PQ qualification, automated audit trails, and 21 CFR Part 11 software packages.

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LCMS/MS (Triple Quadrupole)

Non-volatile organic extractables and leachables

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
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GC-MS / GC-FID

Volatile and semi-volatile organic compounds

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
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ICP-MS

Elemental extractables and leachables

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
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ICP-OES

Multi-element screening of extractables

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
Study Execution Lifecycle

How We Execute Your Study

Standardized 4-stage laboratory workflow ensuring traceability from sample intake to CoA release.

01
Stage 01

Scope & Risk Assessment

Packaging materials identified, risk assessment performed, AET and SCT calculated.

02
Stage 02

Extraction Studies

Controlled extraction using multiple solvents; exhaustive and simulated-use extractions.

03
Stage 03

Analytical Testing

LCMS/MS, GC-MS, ICP-MS screening; compound identification and quantification.

04
Stage 04

Safety Assessment & Report

TTC-based safety evaluation; comprehensive E&L report for regulatory submission.

Scientific Questions & Answers

Technical FAQs

Standard testing is delivered in 30–60 working days. Expedited priority slots are available upon request with dedicated instrument reservations and expedited QC review.
Ready for Sample Testing?

Initiate Your Extractable & Leachable (E&L) Studies Study

Submit your sample matrix or request a pre-study analytical protocol discussion with our senior scientists today.

Schedule Scientific Consultation
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