For inquiries please call 1-919-321-4047 email: bizdev@cirruspharm.com

www.cirruspharm.com

Physical & Chemical CharacterizationCirrus Pharmaceuticals, Inc. is a contract product development organization providing services to the pharmaceutical and biotech industries.

Projects range from sample-based services to feasibility studies to full-scale product development.

Cirrus Pharmaceuticals, Inc. is registered with the United States Food and Drug Administration and is a cGMP compliant facility.

• Light Microscope

• Laser Diffraction System

• Coulometric Karl Fischer

• Powder Flowmeter

• Franz Diffusion Cell

• Dissolution Apparatus

• Optical & Polarized Microscopy

• Electrophoresis (Bioanalyzer)

Physical & Chemical Characterization

• Differential Scanning Calorimeter (DSC)

• Thermogravimetric Analyzer (TGA)

• Fourier Transform Infra-Red Spectrometer (FTIR)

• UV Spectrophotometer

• Tensiometer

• Viscometer

• Osmometer

• HPLC (with UV, MS, ELSD, RI, ECD,

and Fluorescence Detectors)

Ins t rumentat ion• Sieve Shaker

• Microplate Reader

• Tap Density Tester

• Autotitrator

• Dynamic Vapor Sorption

• Zetasizer

• Circular Dichroism

PREFORMULATION studies provide valuable information on the physico- chemical properties of the drug substance and result in well-informed decision making when selecting the drug substance form and optimal delivery system. When drug substance properties are well understood, problems in later stages of drug development are minimized, drug development costs are reduced, and the time from development to market is decreased.

Cirrus scientists have the experience to screen and select a drug substance with the most appropriate properties for the intended drug product.Our services range from single sample analyses to full method development, and comprehensive preformulation studies. We offer a wide range of characterization approaches for small molecules, peptides, and proteins.

Solid State Characterization

Polymorphism • Identification • Screening Crystallization Studies • Thermodynamic Stabilities

Form Selection • Salt Selection, Synthesis, & Characterization • Solid State Stability • Amorphous Form Characterization

Form Characterization • Particle Size & Size Distribution • Hygroscopicity • Crystalline / Amorphous Content • Bulk & Tap Density • Flowability • Surface Area • Crystal Shape & Habit • Wettability

Solution State Characterization

Solution Properties • Dissociation Constant (pKa) • pH-solubility Profile • Solubility in Aqueous • Partition Coefficient (log P, log D) • Intrinsic Dissolution & Non-aqueous Solvents • Surface Tension • Viscosity

Chemical Stability • Degradation Products & Pathways • pH-rate Profiles • Packaging Material Compatibility • Degradation Kinetics & Mechanisms • Excipient Compatibility

Peptide and Protein Characterization

Physical Stability • Aggregation • Denaturation / Unfolding • Adsorption • pH-solubility

Chemical Stability • Degradation Products and Pathways • pH-rate Profiles • Packaging Material Compatibility • Excipient Compatibility • Degradation Kinetics & Mechanisms