Comprehensive Identification of Organic Contaminants with Advanced Analytical Expertise
Even trace organic compounds from packaging or device materials can threaten safety, stability, and compliance – putting your product and reputation at risk.
At Leeder Analytical, we specialise in uncovering those pesky problems before they begin. Our NATA-accredited Melbourne laboratory delivers precise, reliable E&L testing using advanced chromatography and mass spectrometry to:
- Detect complex organic contaminants
- Meet global regulatory requirements
- Ensure product integrity and patient safety
From product launch to regulatory submission, we help you move forward with clarity and confidence.
Understanding Organic Extractables and Leachables
Identifying Critical Organic Contaminants in Healthcare and Consumer Products
Organic extractables and leachables are carbon-based compounds that migrate from plastic, rubber, or other materials into your product – particularly into drug products, medical devices, or consumer goods. These compounds include:
- Plasticizers & Additives: Phthalates, BPA, antioxidants, and UV stabilisers
- Process Residuals: Monomers, oligomers, catalysts, and reaction by-products
- Degradation Products: Compounds formed through oxidation, hydrolysis, or photolysis
- Manufacturing Aids: Release agents, lubricants, and surfactants
Why does this matter?
These organic contaminants can:
- Pose toxicological concerns: Many organic compounds have established toxicity profiles
- Reduce therapeutic efficacy: Through interaction with active pharmaceutical ingredients
- Compromise product stability: By catalysing degradation reactions
- Violate regulatory thresholds: Leading to compliance issues and market delays
Our role is to help you spot and understand these risks, before they become problems.
Why Choose Leeder Analytical for Organic E&L Analysis?
Leeder Analytical delivers specialised expertise in organic compound identification and quantification, backed by decades of experience in advanced analytical chemistry.
- Specialised Organic Analysis: Focused expertise in identifying complex organic contaminants
- Comprehensive Analytical Approach: Utilising GC-MS, GC-MS/MS, LC-MS, and LC-MS/MS for complete coverage
- Method Development Expertise: Custom analytical approaches for challenging matrices
- Structure Elucidation Capabilities: Advanced techniques to identify unknown organic compounds
- Toxicological Assessment Support: Data interpretation for safety evaluation
With our world-class laboratory in Melbourne, Leeder Analytical is the trusted partner for pharmaceutical companies, medical device manufacturers, and regulatory bodies seeking accurate organic compound identification and quantification.
Our Organic E&L Testing Capabilities
We specialise in analysing a comprehensive range of organic extractables and leachables:
- Volatile Organic Compounds (VOCs): Solvents, residual monomers
- Semi-Volatile Organic Compounds (SVOCs): Plasticizers, flame retardants
- Non-Volatile Organic Compounds: Antioxidants, polymer additives
- Polymer-Related Compounds: Monomers, oligomers, and degradation products
- Process-Related Impurities: Catalysts, reaction by-products
- Degradation Products: Oxidation and hydrolysis products
Advanced Analytical Techniques
Our organic E&L analysis employs multiple complementary techniques for comprehensive coverage:
- Gas Chromatography-Mass Spectrometry (GC-MS): For volatile and semi-volatile organic compounds
- Liquid Chromatography-Mass Spectrometry (LC-MS): For polar, non-volatile organic compounds
- High-Resolution Mass Spectrometry: For unknown compound identification and structure elucidation
- Multiple Reaction Monitoring (MRM): For ultra-sensitive quantitation of target compounds
- Headspace Analysis: For volatile organic compounds in closed systems
Comprehensive Testing Process
Our organic E&L analysis follows a systematic approach:
- Consultation & Study Design: We work with you to understand your specific product, materials, and regulatory requirements
- Extraction Studies: Using multiple solvents and conditions to ensure comprehensive coverage
- Screening Analysis: Broad-spectrum identification of potential organic contaminants
- Targeted Quantification: Precise measurement of identified compounds against relevant standards
- Data Interpretation: Expert analysis of results in the context of safety thresholds and regulatory limits
- Comprehensive Reporting: Detailed documentation suitable for regulatory submission
Regulatory Compliance
Our organic E&L analysis helps you meet global regulatory requirements:
- TGA Guidelines for Medicine Containers and Medical Devices
- FDA Guidance for Industry on Container Closure Systems
- EMA Guideline on Plastic Immediate Packaging Materials
- ISO 10993-18 for Chemical Characterisation of Medical Device Materials
- USP <1663> and <1664> on Extractables and Leachables Assessments
- ICH Q3B Guidelines for Impurities in Drug Products
Everything you need to stay audit-ready – with data you can trust.
Need specialised organic leachables and extractables testing?
FAQs
What types of organic compounds do you test for?
Our comprehensive analysis covers the full spectrum of organic extractables and leachables, including:
- Plasticizers (phthalates, adipates, citrates)
- Antioxidants and UV stabilisers
- Monomers and oligomers
- Process residuals and catalysts
- Lubricants and slip agents
- Degradation products
How do you identify unknown organic compounds?
We employ a multi-technique approach for unknown identification:
- High-resolution mass spectrometry for accurate mass determination
- MS/MS fragmentation pattern analysis
- Comparison with extensive spectral libraries
- Retention index matching
- Structure elucidation using complementary techniques
- Reference standard confirmation when available
What is the sensitivity of your organic compound detection?
Our advanced instrumentation can detect organic compounds at parts-per-billion (ppb) levels, with quantification typically in the low parts-per-million (ppm) to ppb range. The specific detection limits vary by compound class and sample matrix.
How do you determine which organic compounds to target?
We employ a risk-based approach considering:
- Material composition and manufacturing processes
- Extraction conditions and product-specific factors
- Known additives in polymers and other materials
- Historical data from similar products
- Regulatory guidance for specific product categories
Can you help with toxicological assessment of identified compounds?
Yes, we provide comprehensive data to support toxicological evaluation, including:
- Accurate identification and quantification
- Comparison to established safety thresholds
- Historical context from similar studies
- Literature references (where available)
- Recommendations for further investigation when needed
How long does organic E&L analysis take?
Standard organic E&L analysis typically requires 2-4 weeks, depending on complexity. Expedited services are available for urgent projects.
Ensure Comprehensive Organic Compound Identification with Expert E&L Analysis
Leeder Analytical delivers specialised organic extractables and leachables testing to:
- Identify and quantify complex organic contaminants with precision
- Support regulatory submissions with comprehensive data packages
- Protect product quality and patient safety through expert analysis
Contact Our Experts Today for a customised organic E&L testing strategy tailored to your specific needs.
Call: +613 9481 4167
