One-Stop-Shop Analytical Services

We provide all Pharmaceutical Analyses through our world wide laboratories (GMP accredited, FDA audited)
KTE is certified with ISO 9001:2008 for sampling registration and shipping.

According to GMP, FDA, USP, Ph.EU, BP

  • Assay and Related Compounds
  • Validations methods by HPLC and GC Including:
    Accuracy, precision, specificity/ selectivity, linearity and range, sensitivity, LOQ , LOD , robustness.
  • Heavy Metals by ICPMS, and ICP SFMS –routine analyses (USP 232 and 233 methods)
  • Heavy Metals by ICPMS, and ICP SFMS – validation methods (USP 232 and 233 methods)
  • Residual Solvents by GC and GC-HS
  • Dissolution tests , including automatically profiling
  • Raw Materials Testing Laboratory
  • Final Product Release Laboratory
  • Leachables and extractables tests for packages
  • ID tests by LC MS