ASI’s Services Include:

• Analytical Method Development and Validation
• Release, In-process, and Raw Materials Testing
• Product Performance Testing (Dissolution, Content Uniformity, Release Rate)
• Stability Testing
• Preformulation Studies (solubility, excipients/vehicle compatibility, etc.)
• USP tests
• Analysis of:
  * Cleaning Validation Samples
  * Process Validation Samples
  * Preclinical Dosing Solutions
  * Preclinical and Clinical Samples in Biological Fluids

To provide these services, ASI employs the following analytical techniques:

HPLC (High Performance Liquid Chromatography)

• Multiple automated systems for unattended operation
• Gradient and isocratic pumping systems
• UV-Vis, Florescence and RI detectors
• Acquisition software systems with audit trail

Dissolution

• USP Apparatus 1 and 2
• Extended water bath for 2 liter vessels

Franz Diffusion Cell Apparatus for In-Vitro Release Rate Testing

• 3 banks of cells, 9 cells each

FTIR (Fourier-transform Infrared Spectroscopy)

UV-Vis Spectroscopy

TLC (Thin-layer Chromatography)

Automated Titration (including Karl Fisher water determination)

Wet-chemistry techniques

LC/MS/MS (Services provided through a sub-contract)

ASI is a leading laboratory in developing and validating In-vitro Release Rate Testing (IVRT) methods, which serve as highly specialized performance test for topical dosage forms such as creams, ointments, gels and lacquers. For additional information regarding IVRT testing click here.

For additional information regarding stability storage testing services click here.

Call us at (919) 549-9700 or Email us at info@ASI-RTP.com

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