Pharmaceutical Analysis

The Pharmaceutical Analysis Group provides analytical support for product stability studies, raw material characterization, production release, and method development projects in a cGMP-compliant environment.

Services

• Method development and validation
• NDA, IND, and QC stability testing and program support
• Final product release testing
• Comparator product testing
• Forced degradation studies
• Dosing solution analysis
• Compendial testing
• Formulation development support
• Stability storage on site

Dosage Forms Analyzed

• Solids
• API
• Capsules
• Tablets
• Liquids
• Semi-solids
• Suspensions
• Lyophilized products
• Drug-coated medical devices
• Transdermal patches
• Cytotoxic and Potent materials
• Controlled substances (Schedule 1-5)

Testing Capabilities

Our laboratories perform a complete array of tests to support the drug development process. All instruments are fully qualified and all methods are validated.

• Chromatography - HPLC, GC, TLC
• Dissolution · Physical Characterization
• Impurity identification and profiles
• Polarographic Analysis
• Thermal Analysis
• UV-vis spectrophotometry
• Tandem mass spectrometry (LC/MSMS)
• Ion chromatographs
• Electrochemical analysis
• FTIR

The BASi Edge

• Strong technical staff. 1:4 Senior Scientist/Project Manager to Analyst ratio.
• Project flexibility.  We are committed to work with clients to help meet timelines.
• Program size. Single sample analysis to large stability programs (multiple dose concentrations, packaging configurations, and lots).
• Final report format. C of A, stability table, written text report, or client-defined format. All reports are available in electronic format with esigs.
• Scientist-to-scientist communication. Your point of contact is the Senior Scientist/Project manager assigned to your program.
• Strong regulatory history. GMP FDA inspection in 2003 and 2006 with no 483s.

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