Analytical and Formulation Development Services
We provide analytical support, contract formulation development, and consultation services to pharmaceutical, chemical, and biotechnology companies. Our experienced scientists offer a full range of analytical services from lead discovery chemistry to cGMP release of finished products. Our familiarity and compliance with regulatory requirements of the Food and Drug Administration and other agencies enable our clients to have complete confidence in the quality and acceptability of all analytical data.
Preformulation Services
- Solubility, pH, solution stability
- Moisture content, sorption analysis
- Thermal analysis (thermal behavior, melting point)
- Structural characterization—FTIR, UV/Vis, fluorescence, NMR, MSn
- Particle morphology, size, and size distribution
- X-ray powder diffraction (XRPD)
- Polymorph screening
- Solid state stability
- Drug-excipient compatibility and packaging component compatibility
Formulation Development Services
- Solutions, suspensions
- Emulsions and self-emulsifying drug delivery systems (SEDDS)
- Semisolids for softgel fills
- Powders—blends and lyophilized
- Stability studies—informal and formal studies (ICH) including elevated, ambient, and subambient temperatures, photostability
- Degradation studies—temperature, pH, light, oxidation
- Dosage form design and evaluation: suspensions, solutions, emulsions/SEDDS
Analytical Services
- Method development and validation for drug substance, impurities, and stability-indicating analysis
- Reference standard characterization, impurity identification, and release testing
- Drug substance characterization—identity, assay, impurities, moisture, pH, residual solvents
- Excipient characterization—compendial testing
- Drug product characterization—identity, assay, content uniformity, moisture, dissolution
- Test article and dose formulation analysis—purity, homogeneity, and stability
- Degradation studies on drug substance and drug product
- Capability to synthesize impurities available within RTI
Customized Ancillary Services
- Experimental design approach
- Inventory management
- Repository storage
- Stability storage
- Specialized shipping services
- Chemical synthesis, radiolabeling
- Regulatory consulting
Compliance
- Registered with FDA as an analytical testing facility
- Registered with DEA for scheduled drug substances
- cGMP/GLP-compliant studies or R&D-type feasibility studies
Instrumentation and Equipment
- Instrumentation
DSC; TGA; XRPD; ESEM; VTI-SA vapor sorption analyzer; particle size distribution; optical microscope with hot-stage and digital imaging; pH meter; Karl Fisher titrator; rheometer; UV/Vis; fluorescence; FTIR; disintegration apparatus (USP); dissolution apparatus (USP, apparatus 1 and 2); ICP-MS; ICP-OES; ICP-high resolution MS; CE with PDA; GC with GC/MS; UPLC and HPLC with LC/MS, PDA, UV, ELSD, RI, fluorescence, and mass spectrometry (API 3000, 4000 (2), 4000 Q-trap (2), and 5000 LC/MS/MS systems; Agilent 6410 LC/MS/MS; Waters Acquity TQD LC/MS/MS; Thermo Electron LTQ, LTQ ETD, and LCQ Deca LC/MSn) - Equipment
Freeze dryer, Silverson homogenizer, propeller mixer, Polytron homogenizer, rotary evaporator, ovens, V-shell blenders, Fitz mill, stability chambers, freezers, refrigerators, laminar flow hoods, stand-alone barrier facility for toxic compounds
Related Research
Contact us for more information
- Brian F. Thomas