Analytical Services

Analytical Services2018-07-16T17:30:45+00:00
Analytical Services

We are a leading provider of contract drug product clinical development, commercial manufacturing, and analytical services to all sectors of the pharmaceutical industry.

Halo has complete in-house capabilities to handle all drug substance, drug product and compendial excipient testing needs. From method development through validation, Halo offers pharmaceutical testing services for any phase of development. In addition, Halo is equipped to handle stability programs on drug substance and drug product at all ICH conditions including stability testing of controlled substances. Halo can perform phase appropriate analytical validation for Phase 1 clinical drug products up to Phase 3 and commercial.  In order to save time, our analytical teams can develop methods for assay, impuritites or related substances and dissolution for IR and MR products.

Our equipment list includes but is not limited to:

  • Gas chromatography (GC) [Agilent with FID, TCD detection]
  • High pressure liquid chromatography (HPLC) [Waters and Agilent] with UV/Vis, PDA, ELSD detection
  • Ultra-High Pressure Liquid Chromatography (Waters) with UV/VIS, PDA and ELSD detection
  • Viscosity testing and measurement
  • Particle size analysis [Malvern, Ro-tap, Air-Jet Sieve]
  • Moisture analysis: Karl Fischer and Colorimetric Titrations
  • Dissolution USP Apparatus I and II (Distek, Vankel and Sotax dissolution units) along with Autosampler Agilent 8000 and Sotax AT70
  • FTIR (Perkin Elmer)
  • FT-NIR (Thermo Nicolet Antaris)
  • UV Spectrometry (Agilent)
  • Atomic absorption spectrometry
  • Water activity tester (Aqua lab)
  • Fluorescence spectrophotometer
  • Osmometer
  • Viscosity (Brookfield)
  • Densimeter (Precision & Anton Paar)
  • Penetrometer (Precision)
  • Polarimeter (Perkin Elmer)
  • Conductivity Tester (Swan and Horiba)
  • Photostability Chamber (Atlas)

Analytical Techniques

  • Forced Degradation (Stress) for the detection of impurities or degradation products
  • Method Development and Validation of Test Methods for Active Drug Substances and Drug Product
  • Analytical Method Transfers
  • Development and Validation of Analytical Cleaning Analyses and Studies
  • Process Validation Characterization
  • Residual Solvents as USP <467>
  • Qualitative and Quantitative analysis
  • Wet chemistry

Stability storage capabilities

ICH stability storage is available at the following temperatures and humidities.

TEMPERATURE HUMIDITY
-20°C
5°C Ambient
25°C 60%RH
30°C 65%RH
30°C 75%RH
25°C Ambient
40°C 75%RH

Halo offers a wide range of ICH stability storage services including stability storage of controlled substances:

  • All chambers kept physically locked
  • Audible and visual alarms for temperature and humidity
  • Back-up generator UPS on data logger ensuring continuous monitoring and alarm call outs
  • Facility monitored by access control