Analytical Testing

Analytical testing is the activity that will provide information about the characteristics and quality of your product. In order to obtain a comprehensive view, different analytical tests and instruments are used to examine the starting materials, intermediates, and final product.

Characterization is a key element in your product's life cycle. Therefore, analytical testing will be required from early developmental stages through all clinical production stages leading up to commercial production. During the clinical and commercial stages, analytical testing is required for APIs and excipients release for production, finished product release, and stability studies. The methods are chosen based on the product profile as well as the regulatory requirements. 

 

 

​          Tip from our scientists

For commonly used materials, the pharmacopoeia provides test methods and procedures. However, a change in the drug matrix (i.e., different formulations ingredients) will probably require method adjustment or even a new method development.

 
 

Services for you

  • Testing by using methods developed by Nextar or customer's pre-developed methods:

    • Quantitation of Active Pharmaceutical Ingredient (API), antioxidants, and preservatives (assay).

    • Impurity analysis and profiling.

    • Forced degradation studies including photostability, heat resistance, pH effect, etc.

    • Full range of short- and long-term stability studies according to ICH guidelines.

    • Residual Solvents.

    • Water Content by Karl Fischer test (including coulometric measurements).

    • Container and Closure Testing

    • Dissolution and drug release profiling

    • Particle Size Distribution (PSD)

    • Leachables and extractables

    • Zeta potential

    • Cleaning validation methods development and validation

    • Conductivity

    • Tapped density

    • Friability and Hardness

    • LOD- Loss On Drying

    • Melting Point

    • Wet Chemistry Techniques

    • Disintegration

  • Nextar is well equipped with the following state of the art equipment:   

    • LC-MS/MS

    • HPLC systems with the following detectors: UV, PDA, and Corona CAD universal detector

    • UPLC with PDA and Fluorescent detectors

    • UV Spectrophotometer

    • Viscometer/Rheometer suitable for low sample volumes

    • Osmometer

    • Particle Size Analyzers (Malvern) – Multi-angle light scattering (nm to micron scale)

    • Dissolution testers- Hanson with autosampler

    • GC with MS, FID, and TCD detectors including liquid and headspace samplers

    • Karl Fischer (water content) including coulometric measurements

    • LOD- Loss On Drying

    • ROI- Residue on Ignition

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