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Analytical Solutions, Inc.
2300 Englert Drive
Durham, NC 27713 US
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).
In-Vitro Release Rate Testing (IVRT)(Using Franz Diffusion and/or enhancer cells), Analytical Method Development and Validation (IVRT and HPLC), Product Performance Testing (Dissolution, Content Uniformity, Release Rate), Stability Testing and Storage, Preformulation Studies (solubility, excipients/vehicle compatibility, etc.), USP tests, Analysis of: * Cleaning Validation Samples, * Process Validation Samples, * Preclinical Dosing Solutions
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