CMC - Analytical Services

CMC

 

At Frontage, an experienced team of scientists provides analytical services in support of your product development, as well as the chemistry, manufacturing and control (CMC) sections of your DMF, IND, ANDA and NDA filings. Frontage's team is experienced in analyzing a variety of dosage forms including oral solids, liquid, lyophilized, nasal spray, transdermal/topical and other products. Our chemists’ expertise includes chromatography (HPLC, GC, SEC, IC etc.), dissolution testing, Franz cells, ICP/OES or MS, HPLC/MS, GC/MS, Karl-Fisher and titrimetric methods, among others.

Frontage is a FDA registered lab with a DEA license for Schedules I-V controlled substances.

Services

  • Formulation analysis: Material characterization, Compound log P and solubility
  • Method evaluation
  • Method development
  • Method transfer
  • Method validation
  • Forced degradation studies
  • Extractable and Leachable studies (HPLC/MS, GC/MS, ICP/MS)
  • Complete compendial analysis (USP, EP, JP, BP, FCC)
  • API and Finished Product release testing
  • GMP Stability studies for early phase and commercial products
  • Reference standard qualification
  • Comparator product testing
  • Gap analysis
  • Impurity identification and structure elucidation:

Frontage brings specialized skill sets from various chemistry disciplines and equipment to efficiently elucidate the structures of unknown compounds found in APIs and finished products during stability evaluations. We employ a systematic approach for identification and isolation of these compounds, allowing for projects to be quickly and successfully completed.