Analytical Development and Quality Control
Analytical Development and Quality Control Services
Pharmaron’s integrated analytical teams offer comprehensive and high-quality analytical solutions in new drug development from preclinical to commercial production. Our integrated analytical teams utilize state-of-the-art equipment to deliver advanced solutions to API and drug product to meet all analytical technical and compliance challenges.
Pharmaron’s integrated solutions are tailored to each phase of the drug development program. Our teams have regular internal audits and are trained to ensure that the cGMP standards are maintained throughout the drug product development and manufacturing life cycle.
- Phase-appropriate achiral and chiral analytical method development, qualification, validation, tech transfer
- Impurity/degradant isolation, identification, characterization and profiling studies
- Genotoxic impurity method development, validation, testing and certification
- Trace metal method development, validation & testing
- Reference standard characterization, qualification and management
- Setting up specifications for in-process, drug substance and drug product
Capabilities
Analytical Development & QC
- Process control strategies from RSM to API to DP and analytical QC for manufacturing
- Cleaning method validations and verifications
- Formulation solubility, dissolution, disintegration and permeability studies
- Microbial Limit Test validation and testing
- cGMP batch release testing for API drug product and certification
- Forced degradation studies for drug substance and drug product
- ICH stability studies for drug substance and drug product
- Integrated data integrity and analytical data management system
ICH Stability Services for Small Molecule APIs and Drug Products
- Protocol development and stability study management
- Rigorous stability testing
- Storage under a range of conditions (frozen, refrigerated, long-term, intermediate, accelerated stability storage)
- ICH stability studies for IND/NDA/ANDA
Analytical Techniques
- Chromatography: UHPLC, GC, IC, SFC
- Detection: UV, DAD, ELSD, CAD, FID, µ-ECD, IC-CD, IC-ECD
- Mass spectrometry: LC-MS, LC-MS/MS (Q-TOF, TQ), GC-MS, GC-MS/MS
- NMR: 1H-NMR, 13C-NMR, multinuclear NMR, 2D-NMR
- Structural identification: NMR, HRMS, FT-IR, UV
- Solid-state characterization: XRPD, DSC, TGA, DVS, PSD, microscopy
- General testing: KF, potentiometric titrator, ROI, polarimeter
- Elemental analysis: ICP-OES, IPC-MS
- ICH stability and photo-stability chambers
