Services & Solutions
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CMC-Product Development & Manufacturing
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Analytical Services
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Analytical Small Molecule
Dedicated teams for small molecule expertise
At Frontage, our analytical lab is well equipped and can provide variety testing for small molecule drug substances and drug products.
Small molecules are still used in many therapeutics and can be challenging to work with, which is why Frontage has a dedicated team with experience with formulation developments on various dosage forms, fully characterization of molecules, and GMP testing on drug substance and drug products..
Analytical Testing on Drug Substances
Frontage has equipped advanced instruments to perform various tests for drug substances, including characterization, GMP release and stability to support Drug Master File (DMF) filing and drug product manufacturing.
- Impurity Profile characterization and unknown impurity structure identification
- Solid characterization by DSC (Differential Scanning Calorimetry) and TGA (Thermogravimetric Analysis)
- Quantitative analysis by GC and HPLC with multiple detectors (DAD, RI, CAD, FLR, ELSD and MS)
- Elemental Analysis by ICP-MS and ICP-OED
- Residual Solvent Analysis by GC-FID and GC-MS
- Trace level genotoxic impurity analysis by high end LCMS (High Resolution MS and MS-MS)
- ICH Compliant Thermal/Humidity and Photo Stability Storage, 24/7 generator back up and e-monitoring
- Full USP monograph microbiology test
Analytical Testing on Drug Products
Frontage is a fully GMP compliant testing lab, can support testing from early non-clinical, clinical products to final commercial product testing throughout the whole drug product development process. Our analytical service can cover drug products in different dosage forms, including solid (tablets, capsule), semi solid (gel, lotion, ointment) and liquid (injectable, ophthalmic drug, oral solution) etc. We can provide phase specific analytical method development and validation, and other specific testing needs.
- Physical Property Test, include pH, Viscosity, Osmolality, Particulate Matter, Moisture, etc.
- Quantitative analysis by GC and HPLC with multiple detectors (DAD, RI, CAD, FLR, ELSD and MS)
- Impurity Profile characterization and unknown impurity structure identification
- Drug product Performance Assay, including dissolution for solid dosage product, in vitro drug product release for nano particle /microsphere drug product, IVRT/IVPT for semi solid product.
- Extractable/Leachable (E/L) study for drug product container/closure
- ICH Compliant Thermal/Humidity and Photo Stability Storage, 24/7 generator back up and e-monitoring
- Full USP monograph microbiology test
Resources To Consider
Stability Testing
CMC Stability Testing As A Quality Control Measure
CMC GMP Analytical Testing for New Chemical Entities and Commercial…
