Access our separation services at any phase of the drug development process. Our expert scientists routinely isolate materials of interest, including controlled substances and potent compounds, through classic and chromatographic techniques. We perform purification of materials of interest such as APIs and intermediates via HPLC or LPLC on gram to kilogram scale. We also perform chiral resolutions of racemates via HPLC or SFC on multigram scale.
Our skilled scientists systematically monitor process-related impurities and degradants via LC/MS, helping you to develop robust and scalable manufacturing processes.
We have expertly designed our chromatographic and classic methods for the enhancement and isolation of critical impurities. Once isolated (in milligram quantities) from the original source via HPLC or SFC, our skilled scientists use advanced spectroscopic techniques:
- Nuclear magnetic resonance (NMR)
- Mass spectrometry (MS)
- Raman (infrared and ultraviolet)
These techniques are applied directly or in conjunction with capillary NMR and hyphenated techniques such as LC/MS/MS, accurate mass and LC-NMR.
We’ll accurately identify your material of interest at speed. Upon identification of the target impurity, we offer scale-up processes for the isolation of gram quantities of impurities or degradants for use as reference materials. Relative response factors are also determined based on rigorous analytical testing.
We’ll help you to reliably and cost-effectively identify and quantify impurities across your research, development and commercialization processes.
Partner with us and we’ll help advance the development of your compound with chiral method development and chiral HPLC solutions.
Our expert scientists provide you with comprehensive HPLC screening of chiral stationary phases from diverse manufacturers to ensure the achievement of appropriate selectivity and quantitation limit. We can determine the chiral and diastereomeric purity of your drug substances, drug products, intermediates and raw materials.
We’ll get your compound where it needs to go.
Partner with our expert scientists who are highly skilled in chiral method development and delivering rapid, robust solutions including:
- Screening on normal and reverse-phase, polar organic and polar ionic modes, providing a mobile phase array that covers a wide range of polarities.
- Chiral SFC method development to complement chiral HPLC, mostly focusing on applications for preparative resolution processes.
- Qualification of chiral chromatographic methods performed against ICH guidelines
Partner with our experts across all phases of your drug development process and we’ll deliver chiral resolution solutions that will accelerate your scale-up.
Our extensive chiral method development platform using HPLC and SFC allows us to rapidly develop chromatographic methods for scale-up to preparative applications. Our comprehensive in-house inventory of chiral stationary phases (CSP) in bulk and packed columns for SFC and HPLC correlates to the wide array of CSP screened during method development.
We are committed to accelerating your compound. Our skilled scientists conduct resolution of gram to kilogram quantities of racemates on a regular basis for research and nonclinical safety studies.
The combination of SFC and HPLC technology for chiral applications enables us to deliver unmatched throughput, efficiency and quality on each process.
Collaborate with us and we’ll help you develop strategic insights into the manufacturability of your compound with rapid, creative solutions, accelerating the path of your complex molecules to commercial manufacture.
Utilize our chemical purification knowledge and expertise to purify your APIs and intermediates from impurities or degradants using HPLC, LPLC or superfluid chromatography services.
Our dedicated scientists conduct feasibility studies that include:
- Method development
- Component correlation between methods
- Target confirmation by LC/MS
- Method optimization
- Loading studies
- Stability assessments of the isolates during each stage
Enjoy the advantages of green technology and faster isolation. As part of our integrated offering, we employ SFC as a complementary chromatographic tool for compounds or mixtures at the appropriate polarity range.
Upon completion of the feasibility studies, we scale up the process for the purification of your target components with HPLC, LPLC or SFC, depending on the drug development phase and manufacturing stage.
Our extensive inventory of chromatography media for preparative applications (chiral and achiral) provides extensive screening options as well as quicker turnaround on the processes. We apply both classic and chromatographic techniques to isolate materials of interest, including controlled and potent compounds.
- Potent compound isolation
- SFC Purification
- Controlled substance isolation