Analytical Services
Advanced Analytical Support for your Synthetic and Solid Chemistry projects
At Enantia, we understand the critical role that precise and reliable analytical testing plays throughout the drug development lifecycle. Our analytical services provide comprehensive support across drug discovery, drug substance and drug product development. From early-stage research through to regulatory submission, our expert team is dedicated to delivering accurate, consistent results with advanced instrumentation and cutting-edge techniques.
As part of our analytical services, we develop and validate methods for small molecules using state-of-the-art chromatographic, spectroscopic, and mass spectrometric techniques. Our equipment includes a wide range of detectors such as FID, MS, VWD, MWD, DAD, LS, and RI, ensuring sensitive and versatile detection across different analytical platforms.
Analytical support to synthesis activities
- Method development and validation for the determination of chemical and enantiomeric purity
- Assay and Related Substances
- Impurity Profiling and Characterization: identification and quantification of impurities, including out-of-specification and nitrosamine impurities
- Reference standard preparation and characterization. Delivery of a Certificate of Analysis.
- Analysis on demand following existing methods
- Complete small organic molecule characterization
- Purification Services with chiral and non-chiral methods
- Carry-over of impurities
- ICH Stability Testing & Regulatory Compliance
- Forced degradation studies
- Molecular Weight (MW) & Polydispersity Index (PDI) Determination
Solid-state analysis during solid form development
- Identification and characterization of crystalline and amorphous forms
- X-Ray diffraction (XRD) and Thermal Analysis using differential scanning calorimetry (DSC) and thermogravimetric analysis (TGA)
- Particle Size Determination (PSD) using laser diffraction and optical methods
- Unit cell and Absolute Configuration determination through Single Crystal analysis
Physicochemical characterization and pre-formulation studies of candidates and drug substances
- Kinetic and thermodynamic solubility studies
- Intrinsic dissolution rate (IDR)
- Hygroscopicity and water activity studies through Karl Fischer (KF) and Dynamic Vapor Sorption (DVS) studies
- Stability Assessment to monitor transformations during manufacturing and storage at different temperature and relative humidities
- Particle Shape and Morphology characterization
- Excipient compatibility
Solid-state troubleshooting
- Detection and quantification of one crystalline form in another crystalline form. Limit of Detection of crystalline forms in complex matrixes.
- Determination and quantification of an amorphous form in a crystalline matrix or vice-versa
- Evaluation of sample and coating thickness
- Batch troubleshooting: identification of developing and manufacturing issues giving raise to different properties between batches
- Comparability studies: generic vs innovator
- Infringing form detection: crystalline impurity identification in drug substance and drug product, related Hatch-Waxman litigations
- Unkown visible and sub-visible particle isolation and identification
Equipment
At Enantia, we utilize cutting-edge instrumentation and techniques to ensure precise analysis, characterization, and optimization of chemical compounds and solid forms. Our state-of-the-art facilities and expert team enable us to provide high-quality analytical support and comprehensive solid-state research, tailored to meet the needs of your project.