Analytical Testing 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.
Our clients can be assured their samples will be investigated using state-of-the-art instrumentation in the areas of chromatography, spectroscopy, microscopy and polymer testing. New equipment and regular upgrades reflect Oniosome commitment to customized solutions.
Saving of technical manpower to check and interpret results .Saving of time & reduced costs. Appropriate testing as per requirement of respective regulatory agencies.
Pre-formulation & Analytical Services
- Solubility, pH, solution stability
- Moisture content, sorption analysis
- Thermal analysis (thermal behavior, melting point)
- Structural characterization—FTIR, UV/Vis, fluorescence, NMR, Mass
- Particle morphology, size, and size distribution
- X-ray powder diffraction (XRPD)
- Polymorph screening
- Solid state stability
- Drug-excipient compatibility and packaging component compatibility
- 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
- HPLC, GC, GCMS, GCMS-HS,MASS (+ &- mode), MS-MS, LCMS, LCMS-MS,TLC, HPTLC, UV, FTIR,Florescence Spectrophotometer
- NMR Spectrometer 1H,13C,15N,31P, XRD, DSC, TGA,Particle size analysis with Zeta Potential,Dissolution study,In vitro permeation study (Franz diffusion study)
- Confocal laser scanning microscope, SEM (Scanning Electron Microscopy), FESEM, HRTEM, CRYO TEM, HOT stage microscopy/Polarizing microscope
- Atomic Absorption Spectrometer (As, Ba,Cd ,Cr ,Hg, Mg, Ni, Pb, Sb, Se, etc…), Elemental Analysis (C,H,N,S,O,F)