R&D Analytical Solutions

Advancing pharmaceutical development and manufacturing

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

Solving challenging problems

Driving innovation

Driving innovation

Containing costs and building efficiencies

Containing costs and building efficiencies

We offer tailored and quality-focused solutions for your unique needs through:

Rigorous scientific expertise

Rigorous scientific expertise

Dedication to quality

Dedication to quality

Adherence to best practices

Adherence to best practices

Services leveraging state-of-the-art laboratories and extensive scientific expertise

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, n-IR, 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)

Contact us

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