Specialty Analytical Services

  • Radiochemical analyses

  • Impurity isolation and synthesis

  • Impurity identification and structure elucidation

  • Extractables and leachables programs

Although many research organizations can see a compound through the basic test procedures, Ricerca is one of only a handful of drug development partners that can see your program through the most difficult analytical problems.

 

Impurity isolation and synthesis

For compounds in need of more technical testing capabilities to succeed, Ricerca scientists and technicians utilize multiple prep-HPLC instruments to physically isolate impurities or identify chemical entities. Among our services:

  • Fraction collection and fraction concentration

  • From milligram to sub kilogram capacity

  • Peak purification

  • Isolation of materials for subsequent preclinical testing if synthesis is not a quick option

Impurity identification and structure elucidation

Ricerca also offers the complete spectrum of services needed to perform impurity characterization:

  • Chromatographic (GC, LC, IC) and ICP expertise

  • MS (GC and LC), MS-MS and NMR for structure elucidation

  • cGMP preparative-HPLC for isolation and purification

  • Synthetic chemistry capabilities to manufacture confirming material and standards

  • Process chemistry knowledge to determine the likely source of impurities, as well as the process optimization skills to eliminate them

Radiochemistry

With more than 25 years of experience providing custom radiosynthesis services for metabolism, toxicology and environmental-fate studies, Ricerca’s combination of technical skills and history of producing high-quality radiolabeled (14C, 3H) or stable-labeled (13C, 2H,15N) compounds gives development teams the best possible support to meet project requirements.

 

Our services include the cGMP preparation and release of APIs along with a certificate of analysis, and the preparation of high-purity radiochemicals and separation of chiral isomers. Ricerca is relatively unique in offering radiosynthesis and biology studies at a single site for unstable-labeled test articles. Radiochemistry services include:

 

  • 14C Labeled polymer synthesis

  • Storage and distribution of labeled compounds

  • Dilution of labeled compounds (including cGMP blending)

  • Stability studies with or without full GLP controls