The Formex Analytical team provides dedicated analytical support for all Formulations and Manufacturing projects, performing stand-alone Analytical Services as well. State of the art methodologies are utilized from raw material and active ingredient testing to stability and compendial testing. Analytical chemists work closely with formulators to provide comprehensive analytical service necessary for any formulation or manufacturing effort.

Compendial methods can be verified for the formulations being examined. Any analytical method can be transferred from the client, and optimized as needed to accommodate changing formulations. When methods are not available, they can be developed efficiently. All methods developed or transferred can be validated to the extent needed for the Phase of clinical assessment.

Formex offers stability testing and full ICH compliant stability storage for R&D projects and GMP manufacturing projects alike. Our stability services include protocol development, controlled storage facilities, analytical testing and report generation.

R&D Support

The Analytical Services group is composed of Quality Control and Analytical Research Development.

Quality Control is responsible for raw material, stability, and finished product testing.

Analytical Research and Development focuses on method development/validation and testing in support of formulation development.

These services support clinical trials, IND, NDA and aNDA applications. Analytical chemists work closely with formulators to provide comprehensive analytical support.

Method Development and Validation

The Formex Analytical team has the expertise and experience to fully support our client’s drug development efforts. Our Analytical scientists work closely with formulation scientists to provide the best analytical methods in a timely manner. In the absence of existing methods for a project, the Formex Analytical team can adapt related methods or develop new methods for the dosage form under development. Methods can be optimized to accommodate changes in drug formulations.

All methods either transferred in, optimized or developed can be validated at the client’s request. Our Analytical team can suggest the level of validation work to be completed based on the API, the dosage form and what phase of clinical trial assessment the dosage form is intended. Full documentation of all development and validation work can always be supplied for application and regulatory purposes.

Quality Control Testing

The Quality Assurance team at Formex has over 20 years experience, which allows us to provide our customers with a robust yet flexible support system to meet all their regulatory needs.

Our commitment to quality is evident in terms of compliance, reliability, and timeliness. We provide the highest quality by adhering to industry standards, applicable regulations, Good Manufacturing Practices (GMPs), International Conference in Harmonisation (ICH) directives, and industry guidelines in providing our services.

Analytical Instrumentation

Liquid Chromatography:

  • Dionex Corona Charged Aerosol Detector
  • Waters UV/Vis, PDA Detector
  • Waters, Agilent HPLC
  • Waters UPLC

Gas Chromatography:

  • Agilent G6890, G1888 Headspace Sampler

Spectometry:

  • Agilent Cary 60 UV-Vis Spectrophotometer
  • Perkin-Elmer Spectrum 100 FTIR
  • Molecular Devices Spectramax

Particle Sizing:

  • Malvern Mastersizer 2000

Thermal Analysis:

  • TA Instruments Modulated DSC w/Autosampler
  • Perkin-Elmer Pyris Thermogravimetric Analyzer

Dissolution and Disintegration:

  • Agilent Dissolution Test Station w/Autosampler
  • Hanson Research QC-21 Disintegration Test Systems
  • Vankel Enhancer Cell
  • Hanson Research Ointment Disk

Other:

  • Mettler Toledo DL38 Karl Fischer Titrator
  • Leica Polarizing Light Microscope
  • Varian/Venkel Hardness Tester
  • Erweka Friability Tester
  • Thermo Scientific Savant High Speed Solvent Evaporator
  • Rigaku X-Ray Powder Diffraction Analyzer

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