Pharma

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