ANALYTICAL
SERVICES FROM CIRRUS PHARMACEUTICALS
A full range of analytical services in support
of pharmaceutical and biotechnology product development is
offered at Cirrus. The services include method transfer, method
evaluation, method optimization, method development, method
validation, rapid analysis, forced degradation, stability
studies, impurity isolation, impurity identification, extractables
and leachables evaluation, API characterization, dissolution
testing. Our laboratories are equipped with state of the art
analytical instruments used for preformulation, formulation
development and product performance testing of inhaled, nasal,
parenteral, oral, topical, transdermal and novel dosage forms
for small molecules, peptides and proteins. Regulatory submission
required data can be generated using our validated instruments.
Analytical Services: Method Validation
Cirrus is registered with the FDA as a cGMP
testing laboratory, and validates methods developed at Cirrus
as well as methods transferred to Cirrus (that are often optimized
at Cirrus in preparation for validation). Method validation
includes:
- Specificity
- Accuracy and Precision
- Linearity and Range
- LOD/LOQ
- Ruggedness
- Robustness
- Solution Stability
Analytical Services: Related Substances
Identification (Impurities)
Our highly experienced analytical chemists
can identify potential degradation pathways and predict possible
degradation products. Forced degradation studies are conducted
according to ICH guidelines. Degradation products and related
substances can be isolated and purified. If desired, our scientists
can identify the structures of the purified degradation products
and related substances.
Analytical Services: Separation Science
A number of different separation techniques
with various detection modes are employed at our facility:
- High Performance Liquid Chromatography (HPLC)
- Gas Chromatography (GC)
- Liquid Chromatography/Mass Spectrometry (LC/MS)
- Microelectrophoresis
Projects include:
- Semi-preparative purifications
- Assay and impurity studies
- Full-scale stability analysis
Data acquisition and analysis software ensures
that data is collected and stored in a manner compliant with
cGMP regulations and permits a large number of samples to
be analyzed efficiently.
Analytical Services: Rapid Analysis
The analytical scientists at Cirrus have
expertise in LC/MSD (Mass Selective Detection) analysis. We
have developed fast and highly sensitive methods that accelerate
sample throughput yielding accurate and precise sample quantification
at concentrations as low as 1 ng/mL. Using LC/MSD analysis
can achieve 10-fold shorter run times than conventional methods
(e.g., HPLC). The resulting benefit LC/MSD provides for our
clients is an increase in turnaround time for large numbers
of samples.
Analytical Services: Biopharmaceuticals
Cirrus offers clients biomolecular characterization
by employing separation techniques such as size exclusion
chromatography, electrophoresis, isoelectric focusing, total
protein assays, ELISA, enzyme activity assays, secondary structure
evaluations, etc. |
