Preformulation and CMC Support

Kuecept offers bespoke contract preformulation and analytical research services focused on supporting the characterisation, formulation, comparability and stability testing of new active ingredients. Our group has vast expertise within the field of solid-state analysis, which we combine with specialist analytical techniques to give our customers a detailed physico-chemical profile of their development compounds.

In addition, these studies aim to highlight any potential stability and processing problems that may occur and used at the correct time, can help you de-risk your development and choose the correct path for later preclinical and clinical formulation development activites.

Our preformulation / CMC services include:

• LogP/LogD/pKa
• Purity measurements and impurity profiling
• Solubility profiling (pH, biorelevant buffers and aspirated human fluids)
• Stability in human fluids (gastric fluid, intestinal fluid and faecal slurry)
• Permeability assessment (PAMPA, Caco-2)
• Solubility enhancement (solubility in co-solvents, surfactants, complexation agents, salts etc.) see Solent™
• Assay development and validation
• ICH stability (inc. forced degradation studies)
• Initial solid-state properties for crystalline / amorphous materials: optical microscopy, SEM, refractive index, particle size, XRPD, DSC, spectroscopy, moisture soprtion
• Polymorph and salt screening
• Amorphous content detection and quantification (inc. method evaluation)
   

Quality Assured

We work to an internal quality system which assures the integrity of our reports. This system comprises comprehensive scientific and data checks, documented procedures and training records.

Confidential and Secure

We sign a non-disclosure agreement with all customers before accepting samples for analysis. As soon as we receive your samples we will record them in our logbook under an anonymous project related code. Your samples will be stored securely in a locked safe under appropriate conditions.