Extractables and Leachables (E&L) Testing Services

Extractables and Leachables (E&L) Testing

Comprehensive E&L Testing for Regulatory Compliance and Product Safety

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Extractables and Leachables (E&L) testing at ResolveMass Laboratories Inc.

At ResolveMass Laboratories Inc., we specialize in Extractables and Leachables (E&L) testing to ensure the safety, efficacy, and compliance of pharmaceutical products, medical devices, and packaging systems. Our advanced analytical services such as LCMS, GCMS, ICPMS help you detect, identify, and quantify potential contaminants that could compromise product quality or patient safety.

What Are Extractables and Leachables?

Extractables are chemical compounds that can be extracted from packaging materials or medical devices under aggressive conditions.

Leachables are compounds that migrate into a product under normal conditions during storage or use.

Identifying and quantifying these compounds is critical to meet regulatory standards such as ICH Q3E, USP <1663> and <1664>, and ISO 10993.

Our Extractables and Leachables (E&L) testing Capabilities Include:

ResolveMass Laboratories employs cutting-edge instrumentation and techniques to provide accurate and reliable results:

LC-MS/MS and GC-MS Analysis: High sensitivity and specificity for volatile, semi-volatile, and non-volatile compounds.

ICP-MS: Detection of elemental impurities to ensure compliance with stringent regulatory requirements.
FTIR and UV-Vis Spectroscopy: Structural identification of unknown compounds.
Headspace GC-MS: Analysis of volatile organic compounds (VOCs).

Explore the Top 5 Analytical Techniques Used in Extractables and Leachables Analysis—including LC-MS, GC-MS, and ICP-MS—in our detailed blog here.

Stay ahead in your E&L compliance journey by understanding the impact of USP <1663> and <1664>—discover how these guidelines shape your extractables and leachables strategy in our in-depth article here.

Industries We Serve

Pharmaceuticals: Ensuring drug safety and compliance with FDA and EMA guidelines.
Biopharmaceuticals: Verifying the purity and safety of biologics.
Medical Devices: Testing for materials that come in contact with patients or drugs.
Food and Beverage Packaging: Ensuring the safety of materials used for food-grade packaging.
Learn how Extractables and Leachables (E&L) studies ensure the safety of pharmaceutical packaging—explore our detailed step by step guide here.

From risk assessment to regulatory compliance, our expert guide on E&L testing for inhalation and nasal drug products walks you through each critical step—read it here.

The Importance of E&L Testing: Regulatory Perspectives

Why Choose Resolvemass Laboratories?

State-of-the-Art Equipment: High-end HPLC systems with advanced detectors like UV, PDA, RI, and MS.
Expert Team: Experienced chemists specializing in analytical method development and troubleshooting.
Regulatory Compliance: Testing aligned with cGMP, ICH, and USP guidelines.
Customized Solutions: Tailored approaches for unique analytical challenges.

Our E&L Testing Process

Consultation: Understand your product, materials, and regulatory requirements.

Study Design: Develop a testing strategy specific to your needs.

Analytical Testing: Perform comprehensive extractables and leachables analysis.

Data Interpretation: Provide clear, detailed, and actionable reports.

Regulatory Support: Assist with documentation for regulatory submissions.

Understand the key factors influencing the cost of Extractables and Leachables (E&L) testing—from device complexity to regulatory requirements—in our detailed guide here.

Explore how a strategic E&L approach helped mitigate leachables risk in a complex biologic vial system—read our in-depth CRO case study here.

Contact us today

At Resolvemass Laboratories Inc., we are committed to providing innovative and customized solutions that enhance the effectiveness of therapeutic agents. Contact us today to learn how our custom polymer synthesis services can help you achieve your drug delivery goals.

If you want to learn the factors that influence the cost of E&L Testing, read our below article:

Cost of Extractables and Leachables Testing: What Influences the Price?

Choosing the Right Partner for Extractables and Leachables Testing in the United States

FAQ

1. What is the purpose of E&L testing?

The main purpose of E&L Testing is to identify and quantify chemical compounds that can migrate from packaging materials or medical devices into drug products, ensuring product safety, efficacy, and regulatory compliance

2. What regulations govern E&L testing?

E&L testing must comply with guidelines set by regulatory bodies such as:
ICH Q3E for impurities in drug products.
USP <1663> and <1664> for extractables and leachables in pharmaceutical packaging.
ISO 10993 for medical device biocompatibility.
FDA and EMA requirements for pharmaceutical and biopharmaceutical products.

3. What types of products require E&L testing?

E&L testing is necessary for:
Pharmaceutical containers and closures.
Biopharmaceutical products.
Medical devices and implantables.
Food and beverage packaging.
Cosmetics packaging.

4. What analytical methods are used for E&L testing?

We utilize advanced techniques, including:
LC-MS/MS: For identifying and quantifying non-volatile compounds.
GC-MS: For volatile and semi-volatile compounds.
ICP-MS: For elemental impurities.
FTIR and UV-Vis Spectroscopy: For structural identification.
Headspace GC-MS: For VOC analysis.

5. What is the difference between extractables and leachables?

Extractables are compounds that can be forcibly extracted from materials under extreme conditions.
Leachables are compounds that migrate into a product under normal storage or usage conditions.

6. How long does E&L testing take?

The timeline for E&L testing depends on the complexity of the product and the required analysis. Typically, testing can range from 2 to 8 weeks. Contact us for a project-specific estimate.

7. What are the risks of not performing E&L testing?

Failure to perform E&L testing can result in:
Product recalls or regulatory non-compliance.
Safety risks to patients or consumers.
Delays in product approval.

8. Can ResolveMass Laboratories help with regulatory submissions?

Yes, we provide detailed reports and regulatory support documentation to facilitate your submissions to regulatory agencies such as the FDA, EMA, and others.

9. How do I start an E&L testing project with ResolveMass Laboratories?

Simply contact us to discuss your product and requirements. Our team will design a customized E&L testing strategy and provide you with a detailed proposal.

10. Do you offer consultation services for E&L testing?

Simply contact us to discuss your product and requirements. Our team will design a customized E&L testing strategy and provide you with a detailed proposal.Yes, our experts offer consultation services to help you understand the testing requirements, select appropriate methods, and design a study that meets your regulatory and product-specific needs.

Extractables and Leachables Testing in Canada: Best Practices for Risk Assessment

References:

ICH Q3E: Guideline for Extractables and Leachables (E&L), Dated 30 June 2020

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