Analytical

CMC Analytical Support: Benefit from Our Extraordinarily Broad Experience

Many analytical laboratories develop and validate analytical methods and perform the specific assays required for the CMC section. Few, however, have the breadth of analytical capabilities and instrumentation to handle inorganic and organic substances, and to do physical as well as chemical characterizations, and to develop and carry out cGMP specification testing, stability studies and impurity identifications. At Ricerca, we have the expertise to perform all the analytical support needed for your drug approval and to prepare your entire CMC submission package for INDs and NDAs, shortening your time to file.

Our CMC analytical support services include:

• Method development and validation for determination of identity, potency, quality and purity of drug substance/drug product
  - specification testing
  - impurity profiles
  - bioavailability indicators
  - assays including stability indicating tests
• Characterization of drug substance/product and reference standards (including GMP, GLP capabilities)
  - chemical and physical properties, including organoleptic properties, solubility, mp, bp, optical rotation, etc.
  - proof of structure using elemental analysis, NMR, UV-Vis, mass spectrometry, and stereochemistry
• Polymorph Screening and solid state characterization of APIs
  - Solvent recrystallization, utilizing robotic equipment
  - Chemical and physical characterization of each form
  - Evaluation of stability relationships
  - Process development and engineering capabilities to develop a robust process for the production of the desired form of a given drug
• Preformulation Testing
  Product Properties
  - Solid State Characterization
  - Stability Evaluation
• cGMP QC testing
  - release testing
  - raw materials testing
  - process and cleaning validation
  - specification development
• cGMP stability testing of drug substance/drug product following ICH guidelines
  - 3-5 year storage stability studies
  - forced degradation studies
  - photostability determination
  - stability indicating assay development
• Validation protocols repeatability, internal precision, reproducibility and robustness
• Preparation of process reference standards, degradation products, analytical standards, impurities
• Recertification of release methods for currently marketed drugs