Extractables &
Leachables (E&L)
Testing Services
Comprehensive Chemical Characterization & Toxicological Risk Assessment for Pharmaceuticals, Medical Devices & Packaging Systems.
Advanced E&L studies using LC-MS/MS, GC-MS/MS, ICP-MS, and toxicological evaluation aligned with USP <1663>, USP <1664>, ISO 10993, USFDA, EU MDR, and PQRI expectations.
Trusted E&L Testing CRO in India
Accuprec Research Labs Pvt. Ltd. is a globally reputed Contract Research Organization (CRO) providing Extractables & Leachables (E&L) testing and Toxicological Risk Assessment (TRA) services for pharmaceutical, medical device, packaging, and biopharmaceutical industries. The organization supports global clients with advanced analytical characterization and regulatory compliance solutions.
Accuprec delivers scientifically robust E&L studies for:
- Pharmaceutical packaging systems
- Medical devices
- Combination products
- Pre-filled syringes
- Polymer components
- Elastomers & closures
- Single-use systems
- Bioprocess containers
Why Extractables & Leachables Testing Matters
Materials such as plastics, elastomers, adhesives, coatings, tubing, and packaging components may release chemical substances during manufacturing, storage, or clinical use. These migrated compounds can impact:
- Product safety
- Drug stability
- Device compatibility
- Regulatory approvals
- Patient health
Regulatory authorities now require detailed chemical characterization and toxicological justification under:
- USFDA
- EU MDR
- ISO 10993
- USP <1663> & <1664>
- PQRI
- BPOG guidelines
Incomplete E&L assessment is one of the major causes of regulatory deficiencies and delayed submissions.
Understanding Extractables & Leachables
What Are Extractables?
Extractables are chemical compounds released from materials under aggressive laboratory extraction conditions designed to simulate worst-case scenarios.
Common Extractables Include:
- Plasticizers
- Antioxidants
- Oligomers
- Residual monomers
- Additives
- Processing aids
- Residual solvents
- Metal impurities
What Are Leachables?
Leachables are compounds that actually migrate into the drug product or patient-contacting medium under normal storage or clinical use conditions.
These compounds represent real patient exposure risks and must be fully characterized and toxicologically assessed before regulatory submission.
Our E&L Testing Capabilities
Accuprec utilizes advanced orthogonal analytical techniques to maximize compound coverage and ensure regulatory confidence.
LC-MS/MS Analysis
Sensitive identification and quantification of non-volatile and semi-volatile organic compounds.
GC-MS/MS & Headspace GC-MS
Detection of volatile organic compounds (VOCs) and semi-volatile compounds (SVOCs).
ICP-MS / ICP-OES
Ultra-trace elemental impurity and metal leachables analysis.
FTIR & UV-Visible Spectroscopy
Material characterization and compound identification support.
HRMS Screening
Unknown compound identification and untargeted impurity profiling.
Our E&L Testing Services
Extractables Studies
Controlled extraction studies under:
- Aggressive solvent conditions
- Simulated use environments
- Elevated temperature studies
- Accelerated extraction conditions
Leachables Studies
Real-time and accelerated leachables evaluation under actual product-use conditions.
Toxicological Risk Assessment (TRA)
Scientific toxicological evaluation including:
- Exposure assessment
- Margin of Safety (MoS)
- Toxicological thresholds
- Daily Allowable Limits (DAL)
- Risk characterization
Unknown Compound Identification
Advanced analytical investigation and structural elucidation of unknown compounds.
Regulatory Documentation Support
Preparation of:
- E&L summary reports
- Toxicological assessments
- ISO 10993 documentation
- Biological Evaluation Report (BER) support
- Regulatory submission packages
Regulatory Standards & Guidelines
Accuprec designs studies in alignment with all major global regulatory frameworks and guidance documents:
USP <1663>Assessment of Extractables
USP <1664>Assessment of Leachables
ISO 10993-17Toxicological Risk Assessment
ISO 10993-18Chemical Characterization
USFDA GuidanceFDA-aligned analytical methods
EU MDR RequirementsEuropean regulatory compliance
PQRI RecommendationsProduct quality research institute standards
BPOG StandardsBiopharmaceutical process guidance
Our Extractables & Leachables Study Process
Material & Risk Assessment
Review of product composition, materials, and intended use.
Study Design
Selection of extraction conditions, solvents, and analytical strategy.
Analytical Testing
Comprehensive screening using orthogonal analytical techniques.
Toxicological Evaluation
Assessment of patient exposure and chemical safety risk.
Reporting & Regulatory Support
Delivery of regulator-ready documentation and scientific justification.
Requirement Understanding
We define a clear analytical strategy aligned to your product and regulatory objectives.
Method Development & Planning
Optimized analytical methods ensuring alignment with ICH, USP, and global standards.
Testing & Analysis
Samples tested using LC-MS/MS, GC-MS/MS, ICP-MS, FTIR, and HRMS platforms.
Reporting & Compliance Support
Detailed, audit-ready reports supporting ANDA, DMF, and eCTD submissions.
Applications We Support
Pharmaceutical Packaging
- Vials
- Syringes
- IV bags
- Closures
- Stoppers
Medical Devices
- Catheters
- Implants
- Tubing
- Drug-device combination products
Biopharmaceutical Systems
- Single-use systems
- Bioreactors
- Filters
- Disposable assemblies
Industries We Support
Pharmaceutical manufacturers
Medical device companies
Biopharmaceutical organizations
Packaging manufacturers
Combination product developers
CDMOs & CROs
Polymer & elastomer manufacturers
Scientific Precision. Regulatory Confidence.
Globally Accredited CRO
- ISO/IEC 17025:2017
- OECD-GLP
- USFDA
- EMA
- NABL
- AAALAC
- CDSCO
State-of-the-Art Infrastructure
- 120,000+ sq. ft. advanced testing facility
- Dedicated E&L analytical laboratories
- Advanced LC-MS/MS, GC-MS/MS & ICP-MS platforms
Experienced Scientific & Toxicology Team
Expert scientists and toxicologists providing end-to-end analytical and regulatory support for every study.
Single-Source E&L & TRA Solution
Integrated analytical characterization and toxicological risk assessment under one roof — faster timelines, seamless documentation.
