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Analytical Development & Validation

Bio-Concept can easily adopt your test methods or develop specific analytical methods for your product.

Highly experienced in developing, qualifying & validating analytical methods.

Our method development services cover a full range of analytical methodology including wet chemical, high-pressure liquid chromatography (HPLC) and gas chromatography (GC). The analytical group employs robust instrumentation such as Waters Alliance 2695 and Agilent Series 1100 HPLCs with multiple detectors including photo-diode array (PDA), UV/Vis, refractive index (RI), CAD, Conductivity and Fluorescence.

Clincal Image For final dosage forms, we develop stability-indicating assays for the active’s potency and related substances as well as methods to monitor preservative concentration. These procedures support both finished product testing and stability studies. Bio-Concept will customize a method validation protocol to your specifications and to meet current ICH or USP/NF requirements.

Our laboratory scientists can also perform a broad spectrum of testing to support your product’s development process:

  • pH
  • UV/Vis Spectroscopy
  • Karl Fisher
  • Osmolality
  • Molecular Weight Distribution
  • TLC
  • Viscosity
  • Particle Size (LASER Diffraction)
  • Specific Gravity
  • Container / Closure Integrity Testing
  • TOC
  • Appearance
  • Leachables
  • Conductivity
All Analytical Testing is conducted in a Quality Control Laboratory according to cGMP Standards.

Capabilities

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