Products
& Services
Methods Development/Validation
The staff of experienced pharmaceutical scientists at QTI are
specialists in developing novel methods of analysis for your products.
We have developed methods using a wide range of analytical techniques
including:
- HPLC
- GC
- GC/MS
- Ion Chromatography
- Dissolution
- UV
- DSC
- TGA
- TLC
- ICP
- AA
- Karl Fischer Water
After a suitable method is developed, we work with our customers
to design and execute a validation study, which meets their specific
technical and regulatory requirements.
Upon completion of a method development and validation project,
the detailed procedures and results are presented to the client
in a comprehensive report. Included are the analytical method,
protocols, all test results, appropriate graphs, calculations
and raw data. Many of our clients receive customized reports based
on their specifications.
Method transfer is an important function at QTI. When a client
has a validated method they want performed, QTI conducts a method
transfer based upon an agreed protocol. This assures that the
method performs according to the client's acceptance criteria
in our laboratory.
Once a successful transfer is completed for a specific method,
the client and regulatory authorities have complete confidence
in the results.
Stability Studies
QTI provides stability testing and storage for our client's projects
in pharmaceuticals, biotechnology, and diagnostics. Our cGMP facility
maintains continuously monitored storage chambers at ICH conditions
with full emergency power backup and security monitoring. The
QA staff has validated all stability chambers following IQ/OQ/PQ
protocols. Additionally we have the capability to handle
special conditions for temperature, light, and humidity for accelerated
testing, as well as controlled substances.
The stability department supports customer studies with a full
range of the latest analytical equipment including HPLC, GC, UV,
and Dissolution. Our fully validated computerized data acquisition
system assures accuracy of results and flexibility in customer
reporting requirements.
We have experience in all types of stability studies from bulk
drug substance to pilot formulations, clinical batches and marketed
products. QTI can support studies with:
- tablets
- capsules
- creams
- lyophyles
- liquids
- sterile products
- transdermals
- metered dose inhalers
- dry powder inhalers
- ointments
- suppositories
- raw materials
- excipients
Results are analyzed statistically and can be reported in customer
supplied format suitable for regulatory submission.
Storage conditions include:
- 25°C/60% RH
- 30°C/60% RH
- 40°C/75% RH
- ICH Photostability Chambers
- Freezers
- Flexible temperature and humidity chambers for special conditions
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