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Impurity Synthesis and Analysis
When something unexpected shows up in the chromatogram, we find out what it is, where it came from and whether it matters.
One place for the whole question
Impurity isolation, identification, synthesis and analytical release run as one service rather than across three suppliers.
- More than 500 impurities of newly launched drugs and clinical candidates delivered
- More than 500 impurities of generic drugs delivered for pharmaceutical companies
- Experience in isomer isolation and formation control, metabolite synthesis, unstable impurity synthesis, and API degradation
- A dedicated team of more than 50 synthetic chemists in impurity synthesis and more than 50 analytical chemists in impurity isolation and analysis
Isolation
- Recrystallization
- HPLC and MPLC
- SFC
- Chiral HPLC
Identification
- HPLC and MS
- GC and GC-MS
- SFC and SFC-MS
- NMR
Synthesis
- Novel chemistry
- Stereochemistry
- Labeled chemistry
- Unstable compounds
- Metabolites
A labeled impurity standard comes from the same chemistry as the unlabeled one.
Release
- Analysis
- Stability studies
Why it is worth knowing the answer
An unidentified peak becomes a specification argument at IND and a rejected batch later. Isolating it, assigning the structure and then making enough of it to qualify a method is the only way to close the question properly.