DifGen Pharmaceuticals LLC, 100, Overlook Center, Suite 2099, Princeton, New Jersey 08540 USA
info@difgen.com

ANALYTICAL R&D

ANALYTICAL CAPABILITIES

1, Qualification of APis , Inactive ingredients and Packaging materials
2. Reverse Engineering determination of Q1/Q2
3. Complex Analytical Charectrization of Petides such as CD, 1D/2D NMR,SV-AUC, SEC-MALLS, LCMS/MS, Intrinsic  Flouresence,SEC-UV, Bio-assay
4. Complex LAI/Depot Injection Charecterization
5. Charecterizations of Liposomes such as Lipid Anaysis Size, distribution, polydispersity, surface charge, Encapsulation efficiency, Qualification of Individual components,lamerality and stability

ANALYTICAL CAPABILITIES

1. In-vitro, Invitro Pelation, Discriminatory method Development
2. Development and Validation of stability indicating Analytical methods, Routine analysis, and stabilty testing for Development.
3. Cleaning method development. Validation and transfer of fineshed product to cGMP site.
4. Photo stability, compatibilty of Diluent /Reconstituent studies(as required by the product)
5. Standalone Analytical service to its partners