The scientific rigor behind the quality standards trusted by manufacturers and regulators around the globe – now available through USP’s R&D Analytical Solutions. New manufacturing technologies and increasingly complex drug formulations pose challenges for manufacturers and pharmaceutical companies to bring products to market.
Supporting you with in-lab analytical & process development by:
Solving challenging problems
Driving innovation
Containing costs and building efficiencies
We offer tailored and quality-focused solutions for your unique needs through:
Rigorous scientific expertise
Dedication to quality
Adherence to best practices
Method development and qualification
Materials characterization
Techniques
Case studies
Examples of method development and qualification work: identification, assays, stability indiciating, impurities, cleaning
Method development and qualification cover evaluation and screening, development and optimization, robustness/forced degradation, validation, and report
Purity analysis: elemental composition, description/appearance, water content, chromatographic purity, potential mutagenic impurities, residual solvents, residual metals, resiude on ignition
Isolation and identification: chromatographic isolation and sample treatment, identification (IR, NMR, MS)
Advanced characterization, including structural characterization and unknowns: qNMR, purity, coutner-ion, elemental analysis, vapor sorption, differential scanning calorimetry, chiral purity, optical rotation
Chromatography: GC, HPLC (PDA, fluorescence, refractive index, CAD, MALs, ELSD), prep HPLC, fraction collector, GCMS, LCMS, hi res LCMS (triple quadrupole, qToF, Maldi, single quadrupole, Orbitrap)
Spectroscopy and PAT: FTIR, Raman, and n-IF, UV-Vis, NMR (high field, benchtop)
Other: ICPMS, IC, oven, stability chamber (heat, humidity, light), KF, pH meter, centrifuge, advanced software packages, (e.g. QbD predictive degradation modeling software, and statistical)
- Low level nitrosamine impurity quantification
- Stability-indicating method development and validation by GC-FID
- Survey of peptide quantification methods and comparison of their reproducibility
- Degradation pahtyway investigation, and identification and structural characterization of a degradation product
For more information about USP’s R&D Analytical Solutions complete the form below.
