Process R&D and Analytical Services
- Autotitrator (Metrohm)
- Chromeleon (Part 11 compliant software)
- EasyMax Synthesis Workstation (Mettler Toledo )
- Fractional & vacuum distillation
- FTIR (Thermo Nicolet IS5) with Omnic Part 11 compliant software
- GC FID 6890 (Agilent)
- GC HS 7697A (Agilent)
- GC/MS (Agilent)
- HPLC (Agilent)
- HPLC 1290 Infinity II (Agilent)
- HPLC-MS 6125B (Agilent)
- IR (Shimadzu)
- KF Coulometer (Metrohm)
- K-F Titrator (Mettler Toledo)
- HPLC-MS (Agilent)
- Melting Point
- NMR 80 MHz
- NMR 400 MHz
- Stability Testing Capability
- HPLC-MS TOF (Agilent 6230)
(All instrumentation regularly calibrated by original equipment manufacturers.)
- Cleaning Methods
- Early Research Activities
- Impurity Identification
- In-Process Control
- Method Development
- Method Validation
Industry-leading R&D and Analytical Services
Effective R&D and Analytical Services are important to your business in spurring growth, controlling costs, and protecting your bottom line. We can help.
We know, for example, that the issues facing the industry around regulations and guidances such as Quality by Design and Q11 require that a fundamental understanding of the impact of impurities on the API quality is of utmost importance. Our analytical scientists, work hand-in-hand with process chemists, and have the tools and expertise to understand the issues related to fate-and-purge of impurities, as well as high level structural elucidation.
Kingchem analytical R&D is a part of our integrated services which also supports process R&D and product launch. We routinely perform method development and validation, release testing, and stability testing. In addition to supporting route-scouting and early research activities, we are also capable of performing production OOS investigations.
Kingchem also has a strong QC department with dedicated specialists for developing (or transferring in from customer), optimizing, and validating analytical methods. Our instrumentation list is continuously growing, and using software such as Chromeleon and Omnic 9 insures that we meet all of the 21 CFR Part 11 requirements for data integrity.
Let our experienced team of chemists, our industry-leading infrastructure of instrumentation and our formal project management process keep your objectives on track. We can set a schedule that moves quickly from route selection, process development and optimization, rapid lab process scale up, and finally through to commercial scale production. Along the way you’ll also realize the benefits of our IP protection mechanisms and our proactive, flexible and communicative style of our operations.
We invite you to contact us to explore how our R&D and Analytical services can help you.