Extractables and Leachables

Extractables and Leachables Testing

Extractables and leachables testing services are essential for pharmaceutical products. They help detect contaminants, ensure product safety, and support regulatory compliance.

At Synergy Bioscience, we provide extractables and leachables testing designed to meet strict industry standards. Our services support raw materials, packaging systems, and finished drug products with accurate and compliant results.

Avoid Contamination Early in Drug Development

Extractables and leachables testing identifies potential contaminants early in development. These contaminants can come from materials, packaging, or processing equipment.

Additionally, testing helps reduce risk before it becomes a problem. It ensures product safety and protects long-term stability.

Monomers, additives, stabilizers, and other chemicals may migrate into drug products under certain conditions. Therefore, early detection is critical.

Our Extractables and Leachables Capabilities Include

Products and Systems

• Pressurized metered dose inhalers (pMDIs)
• Nasal spray solutions and suspensions
• Injectables in vials and bags
• Lyophilized products
• Container closure systems and packaging materials
• Tubing, resins, films, caps, and single-use systems

Testing and Analysis

• Controlled extraction studies using LC-MS and GC-MS
• Direct injection and headspace analysis
• Leachables method development and validation
• Stability study monitoring
• Toxicological risk assessment
• Data interpretation and regulatory reporting

Advanced Analytical Capabilities

Our laboratories use advanced instrumentation to detect contaminants at ultra-trace levels. This includes high-resolution mass spectrometry systems such as LC-MS, GC-MS, and Orbitrap technologies.

Furthermore, our team applies validated methods to ensure accurate and reproducible results across all studies.

Regulatory Compliance and Expertise

Extractables and leachables testing plays a key role in regulatory submissions. Our team supports compliance with global regulatory guidelines, including FDA expectations.

Additionally, our scientists bring years of experience in impurity identification, method development, and validation.

We also apply Quality by Design (QbD) principles to improve efficiency and ensure reliable outcomes.

Toxicology and Risk Assessment Support

We provide integrated toxicological evaluations to assess safety risks. Our experts work closely with clients to determine acceptable limits and identify potential concerns.

As a result, you can make informed decisions about materials, packaging, and product design.

Why Choose Synergy Bioscience

• Advanced analytical technologies
• Experienced scientific team
• Regulatory-focused approach
• Reliable and reproducible results
• End-to-end testing support

Partner with Synergy Bioscience

Partner with Synergy Bioscience for extractables and leachables testing services you can trust. We help ensure product safety, stability, and regulatory success.

Contact us today to learn how we can support your development program.

Monomers and polymer additives such as antioxidants, plasticizers, stabilizers, dyes, metal catalysts and other harmful chemicals may potentially migrate into the product under storage conditions. Synergy Bioscience provides a complete service for testing extractables in container materials and leachables in final products. These tests are conducted in cGMP-compliant laboratories using technologies that detect ultra-trace levels.

Regulations make extractables and leachables studies an essential part of your development process. Synergy Bioscience provides full analytical support for extractables and leachables testing. Our dedicated and highly specialized team has more than 15 years of experience supporting numerous studies for various container/closure selections as well as process qualification and validation for different manufacturing processes.

Additionally, we can deliver an integrated toxicity/safety evaluation by experienced and American Board of Toxicology-certified toxicologists familiar with the application of PQRI recommendations. Our extractable/leachables team and toxicology experts work together to help you make informed decisions on which extractable compounds will be monitored as leachables in long-term stability studies.

Our extractables and leachables capabilities include

• Full extractables/leachables program support for (but not limited to):
  1. Pressurized metered dose inhalers (pMDIs)
  2. Nasal spray solution/suspension
  3. Injectables in bags/vials
  4. Lyophilized product
  5. Stoppers, vials, syringes, bags, nasal spray pumps, labels, adhesives/inks, implantable devices, tubing, resin, film, caps, foil, e-flow devices, gaskets, valves, and disposable materials used in bioprocess (single-use) Manufacturing
• Material and process qualification and validation for in-process manufacturing from an extractables/leachables perspective
• Controlled extraction studies with LC-MS, GC-MS direct injection, and GC-MS headspace injection sample analyses with data interpretation and toxicity assessment services
• Leachables method development and validation studies
• Material qualification for polynuclear aromatic hydrocarbons (PAH), N- nitrosamines, and other toxicologically concerned compounds
• Leachables monitoring for stability studies and routine extractables testing
• Reference standards for many extractable compounds commonly formed during the manufacturing process of the container/closure systems or their resins, including some that are not commercially available

We have extensive experience performing container closure qualifications for all types of container closure systems, designing extractables and leachables programs, and employing Quality by Design (QbD) principles to inform development decisions and meet regulatory requirements for E&L data in an efficient and economical manner.

Our scientists are armed with decades of trace impurity characterization experience, a large arsenal of mass spec and other instruments, and uncompromising resolve. Our state-of-the-art equipment, including HPLC-Orbitrap and Q-TOF mass spectrometers, provide the high-end identification horsepower required for this type of trace analysis.

We offer expert program design and regulatory support, employing a well-defined process to optimize your data package while actively managing “scope creep” often associated with extractables and leachables development. We begin by detailing a program customized to the route of administration and unique characteristics of your drug so deliverables, timing, and costs are predictable.

We’ve drafted sections of multiple NDAs, provided strategic program design to respond to time-bound FDA requests, and drafted responses to FDA deficiency letters.

Contact us to learn how we can help with your extractables and leachables testing, and determine the right strategic fit in your drug development program.

Microbiology Testing Services https://synergybioscience.com/analytical-testing-services/microbiology-testing/ 

FDA guidance on container closure systems https://www.fda.gov/regulatory-information/search-fda-guidance-documents/container-closure-systems-packaging-human-drugs-and-biologics