Drug Outsourcing

Analytical Chemistry R&D Services

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Core Capabilities

  • Method Validation
  • Genotoxic Impurity ID
  • Chiral/Enantiomer Separations
  • Forced Degradation Studies
  • GMP/GLP Stability Studies
  • LC/MS, GC/MS, NMR
  • Raw Materials Release
  • API Release
  • FDA Inspected
  • DEA Registered

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Analytical Chemistry R&D Services Capabilities Sheet

Analytical Method Development & Validation Expertise

At SCYNEXIS, we believe a key differentiator of our Process Chemistry Team is our expert Analytical Chemistry support group. Today’s pharmaceutical environment demands rugged, sensitive and specific analytical methods to support FDA regulatory filings. SCYNEXIS has demonstrated success in developing and validating analytical methods for API’s intended for Phase I clinical trials through NDA submission. We understand the API development industry and continually strive to meet our clients’ most critical deadlines. Our Analytical Chemistry Team leadership consists of tenured veterans from companies including AAI, Catalent, Merck, and GSK.

Phase-Appropriate GMP Validations

At SCYNEXIS, we focus on delivering phase-appropriate method validations in a timely and cost-effective manner. We work in close partnership with our clients to identify the level of analysis and validation required by FDA and ICH guidelines. All validation packages are reviewed by our Quality Assurance Department and in 2009, our GMP systems were audited by the FDA as part of a General Inspection and Pre-Approval Inspection (PAI). No 483’s were issued.

Analytical R&D at SCYNEXIS

Our team works in state-of-the-art facilities with access to a comprehensive suite of cutting edge analytical instrumentation. Highly sensitive genotoxic impurity methods have been developed for numerous clients and we have performed full API release testing for more than 50 programs. A broad array of analytical platforms and techniques is available:

  • Chromatography (LC/GC)
  • Ultra Performance LC (UPLC)
  • Preparative Chromatography
  • OVI by Headspace GC
  • Empower & Chemstation
  • LC-MS/MS & GC/MS
  • NMR (500 MHz & 400 MHz)
  • DSC/TGA
  • FTIR Spectroscopy
  • Agilent, Waters, Varian

Analytical service offerings include:

  • Method Development
  • Method Validation
  • Chiral/Enantiomeric Purity
  • In-Process Reaction Monitoring
  • Genotoxic Impurity ID
  • Reference Standard Qualification
  • Drug Product Stability
  • Dissolution
  • GLP/GMP Stability Testing
  • Forced Degradation Studies
  • Structural Elucidation
  • Raw Materials Testing
  • CMC Documentation
  • API Release Testing
  • API Stability Studies
  • Polymer/Biopolymer Analysis