API CHARACTERIZATION -
PHYSICAL CHARACTERIZATION & CHEMICAL CHARACTERIZATION
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. An understanding
of the physical properties and chemical stability of drug
substance results in well-informed decision making when selecting
the drug substance form and the optimal delivery system. The
experienced scientists of Cirrus' utilize state of the art
instrumentation and work closely with clients in designing
and conducting physical and chemical characterization studies.
Cirrus scientists have expertise in method development and
offer a wide range of approaches for the physical and chemical
characterization of small molecules, peptides and proteins
to meet the clients' needs.
Solid State Characterization
To determine particle size, shape and distribution,
Cirrus has a complete Sympatec® laser diffraction system
and has access to scanning electron microscopy. Additionally,
Cirrus has a Malvern Zetasizer that is used for sub-micron
particle sizing, (e.g., nanotechology projects). Our scientists
can evaluate thermal decomposition profile (TGA) surface area,
crystalinity vs. amorphous content, polymorphism, melting
point, glass transition temperature, hygroscopicity, hydrates/solvates,
FTIR spectra, density, and flowability.
Solution Properties
The partition coefficient (log P) and dissociation
constant(s) (pKa) can be determined at Cirrus. Our scientists
have years of experience solubilizing poorly soluble molecules.
Solubility studies can be conducted and can include a pH-solubility
profile. Once a molecule is in solution, the surface properties
of the solution (e.g., micellar solution, cyclodextrin solution,
emulsion, cosolvent mixture) can be studied via surface tension
measurements. Viscosity/rheological properties and colligative
properties can also be determined at Cirrus.
Solution and Solid State Stability
Cirrus scientists have the expertise to
study degradation kinetics and pathways, to identify mechanisms
of degradation and to conduct studies to provide pH-rate profiles.
Studies to evaluate excipient compatibility and packaging
material compatibility are routinely conducted at Cirrus.
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