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Facility validation support

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If you have a complicated method development or validation project that cannot be performed in-house because of its difficulty, or you need the work finished on a shorter time than your laboratory can do, Nersic can help.  As a partners, we can plan comprehensive protocols for method development, validation, and technology transfer based on regulation of the target market. Our scientists has a proven track record in method developments and validation services using the following techniques with a multitude of drug, natural health products, cannabis, cosmetic & personal care products:

  • Gas chromatography (GC)
  • Gas chromatography/mass spectroscopy (GC/MS)
  • High-performance liquid chromatography (HPLC)
  • Liquid chromatography/mass spectroscopy (LC/MS)
  • Inductively coupled plasma (ICP) spectroscopy
  • Inductive couple plasma/mass spectrometry (ICP/MS)
  • Ultraviolet/visible (UV/VIS) spectroscopy
  • X-ray Crystallography
  • Analytical Microscopy (Light and Electron Microscopes)
  • Fourier Transform Infrared Spectroscopy (FTIR)

The studies involved in Nersic’s validation consulting include:

  • System suitability test
  • Accuracy & Recovery
  • Precision (Test/Re-Test Reliability & Intermediate Precision)
  • Specificity & Selectivity
  • Limit of Detection (LOD)
  • Limit of Quantitation (LOQ)
  • Linearity & Range
  • Samples Stability in Matrix
  • Stock Solutions Stability
  • Specificity
  • Homogeneity
  • Ruggedness
  • Robustness