Drug Substance Support

• Material characterization

• Preformulation

• Dose formulation analysis

If you‘re looking for a drug development partner that can go beyond routine quality control testing and provide serious expertise in preformulation, talk to Ricerca. We have the expertise to guide you through the early stages of development with a full range of state-of-the-art equipment on site.

Ricerca can quickly determine the most thermodynamically stable polymorph and maximize the bioavailability of your drug substance. All of the following studies are performed in-house:

• Dissociation constant (pKas)

• Partition coefficient (log P/D)

• Crystallization screening

• Salt and co-crystal screening

• Solubility

• Hygroscopicity and hydrates

• Stability

• Powder properties

• Polymorph screening

Material characterization and dose formulation is all handled by experienced scientists that can generate toxicity studies, as well as certificates of analysis in support of preclinical lot release or for reference standards. All of the following tests are available on site:

• Chiral purity

• DSC

• FTIR

• Heavy metals

• HPLC assays for purity and impurity content

• ICP

• Karl Fischer

• LC-MS and LC-MS/MS

• NMR (13C, 1H, 19P, 31F) and 2-dimension analysis

• Organic volatile impurities and residual solvents

• Particle size distribution

• Physical appearance

• ROI

• Specific activity

• TGA

• X-Ray diffraction