Nitto Avecia Pharma Services
Analytical Development

Analytical Development

With over thousands of methods developed, validated, and/or transferred supporting IND/ANDA/NDA applications, Avecia Pharma's scientific team has a proven track record in nearly all drug forms, substances, and products.

Partner with Avecia Pharma's analytical development team

Avecia Pharma's analytical development group has experience in support of various dosage forms within the generic and branded pharmaceutical industries. The team's diverse background has enabled Avecia Pharma to develop an in-depth understanding of all facets of the drug development process. In addition, Avecia Pharma offers extensive experience in gap analysis and remedial validation of existing methodologies to comply with current CDER/ICH guidelines for validation.

As development partners, we design detailed protocols for method development, validation, and technology transfer based on the products phase in the drug development process.

At Avecia Pharma, our mission is to provide our clients with outsourcing solutions that make their drug development priorities possible.

Capable Support of Multiple Dosage Forms

  • Injectables (lyo and non-lyo)
  • Transdermal
  • Solids, semi-solids, and liquids
  • Inhalation/Nasal

Extensive Analytical Method Development and Validation Services

  • Assay and related substances
  • Chromatographic purity
  • Stability indicating assays
  • Forced degradation studies
  • Dissolution
  • Gap analysis and remedial validation
  • Residual solvents
  • Extractables/Leachables
  • Chiral drugs
  • Cleaning procedures
  • Characterization of reference standard and drug substances
  • Process validation support
  • Method transfer/training
  • Formulation development and product deformulation support
  • Comparative studies
  • Reference standard qualification
  • Counterfeit product evaluation
  • Vendor qualification

State-of-the-Art Instrumentation

  • Fast Resolution Chromatography:
    Agilent 1290
  • HPLC: Waters, Agilent, Dionex (UV-VIS, conductivity, FLD, PDA, RI, ELSD, CAD)
  • High resolution chromatography
  • GC/MS: Agilent MSD with El and Cl ionization source
  • GC: direct injection and head space capability (detectors: FID, TCD, ECD and NPD)
  • LC/MS: MSD with APCI & ESI
  • IC (conductivity and ECD)
  • DSC and TGA
  • Dissolution (apparatuses I, II, VI)
  • UPLC
  • LC/MS/MS: Quadrupole, triple quadrupole and time-of-flight of mass spectrometers with APCI and ESI
  • HIAC
  • Chromeleon software chromatographic data processor

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