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.
