Formulation Analytical

We provide regulatory-driven, phase-appropriate, CMC laboratory and GMP analytical services. Our expertise ensures sufficient information for your Investigational New Drug (IND), Abbreviated New Drug Application (ANDA) and New Drug Application (NDA) filings. This is achieved through analysis services, pre-formulation and solid state characterization, method development and validation, stability studies, pharmaceutical impurity analysis, extractables and leachables and GMP batch release testing. Our scientists are adept at applying advanced technology in GMP compliant analytical development programs. 

Pre-formulation: Method Development and Validation, Stability Studies, Dissolution Particle Size Distribution, Thermal Analysis,Viscosity, Melting Point/Glass Transition Hygroscopicity, Powder Density /Flowability, Intrinsic Dissolution, Excipient Compatibility, Solubility Dissociation Constant, Specific Gravity, Disintegration 

Formulation: Inhalation, Oral, Nasal, Parenteral, Topical, Transdermal 

Facility & Equipment 

We are located in the heart of the Research Triangle Park life sciences cluster, with biotechnology and pharmaceutical companies, academic research institutions and teaching hospitals. The facility is designed for translational development activities and is well-suited for the development of a wide range of compound types and safety classifications, ranging from parenterals for biotherapeutics to oral dosage forms for small and large molecule. 

All our instruments are new or refurbished to factory specs from major manufactures,chosen for their ability to generate quality results. 

1. PE-Sciex LC-MS, prep HPLC, FT-IR

2. Liophilization

3. Multi-Kilo scale reactors

4. Scale-up reactors

5. API5000 API4000 and API3000 series with triple quard, and Q-trap systems

6. Agilent 1100,1200 series HPLC systems

7. Agilent 5977AGC/MS, fitted with a 7697A headspace apparatus

8. UV/Vis spectrophotometers

9. FT/IR spectrometers

10. Karl Fisher, Optical Rotation

11. Elemental Analysis