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Hydra Phaceutical in-house Analytical Services Team can support complete GMP testing for APIs, finished products and stability samples, thus providing you with the best turn-around time possible for product release and study results.

Further, our in-house Method Development & Validation team can support your needs from method development and validation to method transfer or pharmacopeia method verification.

By having both the MD&V and QC testing teams co-located, we can offer a seamless transition of methods between the two groups.

With our full range of incubators, we can perform all stability studies to support development of your product, as well as annual stability testing.

Method Development and Validation (Chemistry and Microbiology)

Our team of analytical science experts can develop & validate, or transfer, methods to support raw material and finished product testing. The transition to QC testing will be seamless and ensure excellent knowledge transfer.

We can carry out the full range of analytical development activities, including

  • De novo Method Development

  • Forced Degradation Studies

  • Method Validation

  • Method Transfer

  • Pharmacopoeia Method Verification

To specifically support characterization of semi-solids, our scientists have developed an expertise in In Vitro Release Testing (IVRT) using Franz and Enhancer cells

  • Development

  • Validation

  • Routine testing

Analytical QC Testing Solutions

Once developed or transferred, analytical methods will be used by our QC team to perform raw material or finished product testing

  • Chemistry

    • Assay

    • Related compounds / degradation products

    • Refractive index detection

    • Residual solvents (USP <467>) analysis

    • Size exclusion analysis

    • Dissolution


  • Physical Testing

    • Viscosity and basic rheology

    • pH

    • Osmolality

    • Particle size distribution by microscopy

    • Particle size distribution by laser diffraction

    • Droplet size (sprays)

    • Density and Specific Gravity

    • Deliverable volume and weight loss

Equipment Platforms

  • All chromatography instruments are powered by Waters Empower 3 software

    • Gas and liquid chromatography

    • Agilent and Waters HPLCs and UPLCs

    • Agilent GC with headspace

    • Waters LCMS

  • Dissolution apparatus

  • Brookfield viscometers (wide range of equipment)

  • Osmometer

  • Malvern Mastersizer

  • Malvern Spraytech

  • Microscope

  • FTIR and UV spectrometers

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