Services – Analytical Services

Analytical Services

We will be your partners in the Identification, Characterization, Impurity Profiling and Analysis of your products, be it a Pharmaceutical Finished Products, an API or an Intermediate.

ENEM offers a full spectrum of services.

Basic Analytical Services
  • Compendial testing as per USP, EP , BP and IP.
  • Method development, validation and testing for Non-Compendial products.
  • Residual solvent analysis.
  • Comparator testing with RLD.
  • Particle Size Characterization – Dry and Wet.
Stability
  • Stability storage: Accelerated, Long Term and Intermediate Stability testing.
  • Testing of Stability Samples and Trend Analysis.
Profiling and Characterization
  • Isolation and purification of Impurities above Identification Threshold by using Combiflash, Prep HPLC
  • Structure Elucidation of API and impurities by using NMR, LC- MS, FTIR and associated instruments.
Inhalation Testing*
  • By Laser Diffraction as well as Andersen Impactor.
Other Support Services*
  • Synthesis of standards and Impurities.
  • Formulation Development Projects
  • DMF Filing in eCTD format
  • Audit Services

WE OFFER ALL THE ABOVE SERVICES FOR BOTH THE EU, US AS WELL AS LATIN AMERICAN, AFRICAN AND ASIAN MARKETS

*Will be managed by us, but provided through other divisions of our organization.