Analytics laboratories

Endoceutics cGMP analytical laboratories perform method development and validations for pharmaceutical compounds, in accordance with compendia procedures, including USP and ICH, as well as Endoceutics’ SOPs, including for assay of steroid hormones and metabolites.

  • Method development and validation of drug substances and drug products as per ICH guidelines
  • Chemical and instrumental analysis following procedures described in the USP/NF, BF, AOAC, EP, other compendia and clients' procedures
  • Chromatography (HPLC and UPLC) and detection technologies (PDA, MS, ELSD, etc.) to meet the requirements for different types of compounds
  • Stability analyses and appropriate assay methods for drug substances and drug products as per ICH guidelines (all climatic zones)
  • Dissolution assays (IR, ER, MR)
  • Stability storage and testing as per ICH guidelines
  • Dose verification for clinical and non-clinical GLP studies

Endoceutics cGMP-compliant analytical facility is equipped with:

  • Waters HPLC Alliance
  • Waters UPLC H-Class
  • Mass Spectrometry (Sciex API 5000s and Sciex QTRAP 6500s)
  • Environmental chambers for stability studies
  • Clean Room
  • Dissolution equipment
  • PDA detectors from Waters
  • Fourier Transform Infrared Spectroscopy (FTIR)
  • Karl Fischer - Water Determination by Karl Fischer Titration

On March 31st, 2015 the Endoceutics laboratory received, OCDE GLP recognition from The Standards-Council of Canada. The Endoceutics laboratory has been inspected under the authority of the Standards Council of Canada Act (SCC) and observed to comply with the requirements of the OECD Principles of Good Laboratory Practice (GPL) (1998) and the conditions established by the SCC.

The Good Laboratory Practice or GLP specifically refers to a quality system of management controls for research laboratories and organizations in order to ensure the uniformity, consistency, reliability, reproducibility, quality, and characteristics of chemicals (including pharmaceuticals) of the non-clinical safety tests.

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