Selecting an experienced, well-equipped, and qualified analytical laboratory service provider compliant with current good manufacturing practices can make all the difference in the drug development process. Overseen by an experienced quality assurance (QA) team, Moravek quality control (QC) staff utilize an array of qualified instrumentation to perform accurate and reproducible analytical services.
Moravek provides exceptional GMP analytical laboratory services using state-of-the-art qualified equipment. The instruments that we use for our GMP analytical laboratory services are meticulously maintained and qualified by a manufacturer’s certified representative. Some of the instrumentation used for our GMP analytical laboratory services includes:
- UHPLC and HPLC with radio and UV detection: for radiochemical and chemical purity
- LC-MS: for structural confirmation and specific activity
- Headspace GC-MS: for residual solvent analysis
- NMR: for structural confirmation
- ICP-MS: for trace metals analysis
- XRPD: for confirmation of crystal structure
- Particle size analyzer: for confirmation of particle size
- FTIR: for confirmation of identity
- Karl Fischer titrator: for determination of water content
Moravek’s analytical services are an essential part of the GMP production of 14C-labeled active pharmaceutical ingredients (APIs). Our comprehensive GMP analytical laboratory services include:
GMP Analytical Laboratory Services:
- UHPLC and HPLC method transfer
- Proton and 13C nuclear magnetic resonance (NMR)
- Liquid chromatography mass spectrometry (LC-MS)
- Gas chromatography mass spectrometry (GC-MS)
- X-ray powder diffraction (XRPD)
- Particle size analysis
- Inductively coupled plasma mass spectrometry (ICP-MS)
- Headspace gas chromatography (Headspace-GC)
- Karl Fischer titration
- Inquire about additional GMP analysis options
All of these services are performed by our experienced quality control staff. If you have any questions, don’t hesitate to contact us. We are happy to help.