Clinical and Commercial Analytical Support
Providing Quality Release Analysis for Your Drug Substance or Drug Product
We are regarded as the high quality and low risk analytical service provider of choice for the release testing of clinical and commercial supplies. Our proven and extensive expertise supports a diverse range of dosage forms, including:
- Tablets and capsules
- Powders and granules
Analysis techniques include:
- HPLC / H(U)PLC
- GC (with headspace)
- Ion chromatography
- Karl Fischer water determination
- Identity by FTIR, 1H NMR, 13C NMR, 19F NMR, 31P NMR, XRPD and MS
- LC-MS / GC-MS
- Particle size
- Quantitative NMR
We are also able to support elemental analysis for the updated USP<232> and USP<233> chapters, with the use of fully GMP ICP-MS.
The synergy with our clinical trial supply services enables the rapid and effective analytical support for comparator testing, including method development and release.