Extractables & Leachables (E&L) Testing

Extractables & Leachables (E&L) Testing
Product Description

Container closure systems, drug delivery devices, and packaging materials can introduce potentially harmful chemical entities into drug products — making Extractables and Leachables (E&L) testing a critical component of pharmaceutical safety and regulatory compliance. ResolveMass Laboratories offers advanced mass spectrometry-based E&L studies that meet the evolving expectations of FDA, EMA, USP, and ISO standards, including USP <1664> and ISO 10993 frameworks.

Our extractables studies employ a broad battery of analytical techniques — including GC-MS, LC-MS/MS, ICP-MS, and headspace analysis — to comprehensively identify and quantify chemical entities that may migrate from materials under controlled extraction conditions. We apply both targeted and ...

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ResolveMass Laboratories Inc.

  • Country/Region:
    Canada
  • On CPHI since:
    2026
  • Certificates:
    3
  • Employees:
    1 - 24
Company types
Start-up
Primary activities
Analytical Services
Biopharmaceutical
Chemical Development
Contract Manufacturer
Contract Research Organisation
Out-licensing specialist
Pharmaceutical Company (generic finished products)
Pharmaceutical Company (innovator finished products)
View company profile
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Specifications
  • Selling Points
    Quality Service
  • Supplied from
    Canada
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ResolveMass Laboratories Inc.

  • Country/Region:
    Canada
  • On CPHI since:
    2026
  • Certificates:
    3
  • Employees:
    1 - 24
Company types
Start-up
Primary activities
Analytical Services
Biopharmaceutical
Chemical Development
Contract Manufacturer
Contract Research Organisation
Out-licensing specialist
Pharmaceutical Company (generic finished products)
Pharmaceutical Company (innovator finished products)
View company profile

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    Product Biosimilar Development Services

    The development of biosimilar products demands an exceptional level of analytical precision and regulatory sophistication. ResolveMass Laboratories provides end-to-end analytical and bioanalytical support across all stages of the biosimilar development continuum — from early feasibility and fingerprinting ...

ResolveMass Laboratories Inc. resources (1)

  • ResolveMass Laboratories Inc. Expert Pharma R&D, Polymer Synthesis & Testing Services

    Video ResolveMass Laboratories Inc. Expert Pharma R&D, Polymer Synthesis & Testing Services

    Welcome to ResolveMass Laboratories Inc., your dedicated partner in advanced pharmaceutical research and development. Based in Canada, we are a leading Pharma CRO and CDMO specializing in bridging the gap between complex science and real-world applications.At ResolveMass, we believe that Your R&D is Our Responsibility. Our team of PhD-level scientists brings deep technical mastery to every project, ensuring the highest standards of safety, compliance, and innovation. Our Specialized Services: Polymer Experts: Specialized in PLGA, PLA, and custom polymer synthesis for novel pharma projects. Nitrosamine Testing: Precision testing to ensure safety and regulatory compliance. Extractables & Leachables (E&L): World-class testing to protect the integrity of your pharmaceutical products. Custom Development: Tailored so
    2026-05-06