Analytical Laboratory in Irvine, California

Analytical Testing Services for Pharmaceutical Manufacturers

Contract Analytical Testing Services

LGM Pharma’s analytical laboratory supports pharmaceutical development and manufacturing programs from early-stage development through commercial production.

We extend internal CDMO/CMO capabilities by providing comprehensive testing services for drug substances and drug products, including:
  • GMP release testing
  • Stability studies
  • Method development
  • Manufacturing support testing

LGM Pharma supports analytical testing needs at our Irvine, CA facility.

LGM Pharma’s analytical laboratory supports pharmaceutical development and manufacturing programs from early-stage development through commercial production.

  • FDA-inspected
  • cGMP-compliant
  • ISO 9001-certified
  • DEA-registered for controlled substances

Our team offers a comprehensive suite of testing services for Manufacturers:

Manufacturing Support Testing

Testing equipment lines for any residual API or associated cleaning agents that may remain after cleaning:

  • Total Organic Carbon (TOC)
  • API or detergent residue to each equipment component – Provide Method Development/Validation
  • Microbial Assessments

Water System Validation

Testing water systems per USP:

  • Purified Water
  • Bulk Water
  • Water for Injection (WFI)

Testing Services

  • Bacterial Endotoxins
  • Conductivity
  • Microbial Counts
  • Total Organic Carbon (TOC)

GMP Release Testing

    Raw Materials/ Drug Substance/ Drug Product

    • ID
    • Assay
    • Wet Chemistry Tests
    • Compendial Testing (USP, EP, JP)
    • Microbiology Testing

    Impurities Testing

    • Residual solvents
    • Elemental impurities
    • Degradation impurities

    Stability Studies

    • Real-time stability testing
    • In-use stability studies
    • Accelerated stability testing
    • Forced-degradation stability studies
    • Formulation stability studies
    • Biologics stability studies
    • Freeze-thaw cycle studies
    • Photostability
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Blog: Stability Testing for Pharmaceutical Manufacturers

Read this guide to stability studies, shelf-life determination, and ICH stability requirements supporting pharmaceutical product development and regulatory submissions.

READ THE STABILITY TESTING GUIDE
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Whitepaper: Outsourcing Analytical Testing: Three Problems to Avoid

Contract analytical laboratories help pharmaceutical companies manage capacity constraints, maintain lean internal teams, and keep development timelines on track.

DOWNLOAD THE WHITEPAPER

LGM Pharma Core Services

cbox AnalyticalTesting - LGM Pharma

Analytical Testing Services

We tailor our services based on the unique regulatory requirements of various segments of the pharma industry.

EXPLORE OUR TESTING CAPABILITIES
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API Sourcing & Supply Chain Management

We leverage our network of over 220 pre-qualified API manufacturers and handle all logistics and regulatory requirements.

EXPLORE OUR DRUG SUBSTANCE SOURCING SERVICES
cbox CDMO SemiSolid - LGM Pharma

Drug Product CDMO Services

We provide U.S.-based development and manufacturing of solid, liquid, semi-solid, and suppository dosage forms.

EXPLORE OUR DRUG PRODUCT CDMO SERVICES