Analytical Solutions, Inc.

Overview

Analytical Solutions, Inc. is a contract analytical laboratory that provides quality, timely and cost-efficient CMC-related analytical services to the pharmaceutical and nutraceutical industries. The company specializes in developing performance tests for topical and transdermal dosage forms. Work is conducted in compliance with FDA GLP and GMP regulations as required.

Analytical Solutions was founded in Durham, NC in 1994 by Dr. Kailas Thakker. Working closely with regulatory and compendial agencies, Analytical Solutions has emerged as a leader in the development of topical and transdermal dosage forms, successfully developing and validating numerous in vitro release test (IVRT) methods over the past ten years. Such method development work often supports formulation development; supports changes in manufacturing processes, composition or manufacturing sites; or supports post-marketing manufacture release testing (as per FDA's SUPAC-SS guidelines).

Standards & Methodologies

HPLC (High Performance Liquid Chromatography), Dissolution, Franz Diffusion Cell Apparatus for In-Vitro Release Rate Testing, FTIR (Fourier-transform Infrared Spectroscopy), UV-Vis Spectroscopy, TLC (Thin-layer Chromatography), Automated Titration (including Karl Fisher water determination), Wet-chemistry techniques,

Qualifications, Certifications, Accreditations & Licenses

Performs testing in compliance with FDA GLP or GMP regulations. Licensed to handle controlled drug substances (schedules 1-4).