Equipped for your science

Equipped for your science

Lannett has complete capabilities to put science to the test. We provide complete analytical development services. Our approved SOPs command specific requirements to method validation, verification, and/or transfer of testing procedures to ensure accurate results.

Our laboratory team is experienced, trained, and adaptable to any changes in the timeline. We are able to anticipate steps and reduce the number of surprises that could impact a project’s success.

Equipped for your science
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Flexible & Unique Formulation Development Solutions

We provide cGMP clinical material and commercial products via a variety of technologies.

Flexible & Unique Formulation Development Solutions
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    Dosage forms to support PK and tox studies
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    Optimization of existing formulations
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    Process development and scale-up
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    Excipient compatibility and dosage form design
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    Improved safety and efficacy
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    Reverse engineer formulation

Analytical Laboratory Services

Lannett’s laboratories are well-equipped and spacious; our large walk-in and reach-in stability chambers can be validated at a variety of conditions, the common being:

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    Long-term (25°C and 60%RH or 25°C and 40%RH)

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    Intermediate (30°C and 65% RH)

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    Accelerated (40°C and 75%RH or 40°C and 25%RH)

Analytical Laboratory Services

Analytical Tests

Analytical Tests
  • Method development and validation
  • Raw material, Packaging material, in-process, and finished product release testing
  • Full ICH stability finished product storage and testing
  • Physiochemical testing
  • Elemental Impurities
  • Residual Solvents
  • Extractables/ Leachable’s
  • Test procedures evaluated every five years

Analytical Methods

Analytical Methods
  • Chromatography: HPLC/UPLC with UV/RI/Conductivity/CAD, GC, TLC
  • USP Dissolution Apparatus 1, 2 and 7 testing
  • ICP-MS testing
  • UV-VIS spectroscopy
  • Atomic Absorption spectroscopy
  • Particle Size testing: Sieve, Laser diffraction
  • Total Organic Carbon (TOC) testing
  • Physical Properties: Refractive Index, Specific Density, Viscosity, Polarimetry,
    Moisture Content

Microbiology

Non-sterile Microbial Tests

Non-sterile Microbial Tests
  • Method suitability Testing
  • Raw material and finished product release testing
  • Water Activity Testing

Non-sterile Microbial Methods

Non-sterile Microbial Methods
  • Microbiological Examination of Non-sterile Products per USP <60>, <61>,
    <62>
  • Antimicrobial Effectiveness Testing per USP <51>
  • Water Activity Testing per USP <922>

Ask us about our formulation and analytical services

Contact Us