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.
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:
- UV/Vis Spectroscopy
- Karl Fisher
- Molecular Weight Distribution
- Particle Size (LASER Diffraction)
- Specific Gravity
- Container / Closure Integrity Testing
All Analytical Testing is conducted in a Quality Control Laboratory according to cGMP Standards.