We can develop new methods or improve existing ones for your early drug development work through chemical manufacturing controls (CMC). The methods we create support the rapid testing of pre-clinical samples, formulation prototypes, and commercial samples. The resulting test methods are invaluable in ensuring drug identity, purity, potency, and performance.
Analytical Development Projects
Here are the steps most common to these projects:
- Plan out the method development.
- Generate the procedures for testing.
- Perform method validation and qualification protocols.
- Generate the validation and qualification test methods.
- Generate the validation/qualification reports.
- Transfer the technology.
LSI offers a wide range of anlytical testing, including thermal gravimetric analysis (TGA), differential scanning calorimetry (DSC), and modulated DSC. These methods are useful in finding:
- temperature and heat of fusion, vaporization and crystallization
- heat of reaction, including polymerization, oxidation and combustion
- temperature and heat of decomposition (e.g., dehydration)
- heat of solution, adsorption or desorption
- specific heat, activation energy, polymer crystallinity, curing time
- material purity, thermal and oxidative stability
- reactivity and reaction rates
- temperature and glass transition, softening
Particle Size Analysis
LSI also offers extensive particle size analysis. Particle size is the most important physical characteristic of particulate samples because it is an indicator of quality and performance. This is true in suspensions, powders, emulsions and aerosols. Smaller particles flow and distribute better, and materials of similarly sized particles are not as likely to segregate when combined, so particle size analysis is an important step in many industries.
Other Analytical Services
We use state-of-the-art instrumentation to support projects in medicinal chemistry, process development, drug formulation, pre-clinical and clinical drug development, and quality control of raw ingredients. For info or to request any of our services, please contact us.
LSI analytical services include:
- chromatographic separation
- quantitation of major and minor components in raw API and formulated drug products
- identification of impurities generated during manufacturing, stress testing, and stability studies
- analytical support for the design, synthesis, and scale-up of new chemical entities
- development of qualitative and quantitative analytical methods in HPLC, LC/MS or LC-MS/MS for support of pre-clinical drug discovery studies
- method qualification
- acquisition, processing and reporting of pre-clinical and pharmacokinetic and toxicokinetic data, including ADME, protein binding and metabolites identification
- development of qualitative and quantitative bio-analytical methods using LC-MS/MS (Applied Biosystems/MDS SCIEX API 4000 triple quadrupole mass spectrometer) for small molecules and metabolites in biological matrices (plasma, urine, and various tissues)
- analytical support for pharmacokinetics studies, dose formulation and dose verification, metabolite identification, stability, solubility, and other experimental needs
- development of small molecule extraction protocols for various biological matrices using liquid-liquid extraction (LLE), solid phase extraction (SPE) and protein precipitation techniques.
- PK data generation and interpretation for non-compartmental analysis using WinNonlin software.
- 96-well sample processing and analysis.
Contact us today to see how we can fill your analytical needs.