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Technical Bulletins
"Finding Peaceable Photostability" article as seen in the April/May issue of PFQ magazine.
Authors: Robert W. Dotterer, Applications Engineer at CARON, and John Allen, Ph.D., Associate Professor of Chemistry at Indiana State University, Terre Haute. Click to download PDF White Paper: "Using Photostability Testing Chambers to Meet the Requirements of Drug Testing in Accordance with ICH Q1B"
Author: Bob Dotterer, Applications Engineer Click to download PDF Guidelines for the Stability Testing of New Drugs and Substances (ICH Topic Q1A(R2))
For US Markets: Federal Register Q1A(R2) For US Markets: Federal Register Q1A(R) For European Markets: European ICH Q1A(R2) For Canadian Markets: Canada Q1A(R2)_E Guidelines for the Photostability Testing of New Drugs and Substances (ICH Topic Q1B)
For US Markets: Federal Register Q1B For European Markets: European ICH Q1B For Canadian Markets: Canada Q1B_E Guidelines on Stability Testing of Biotechnological/Biological Products (ICH Topic Q5C)
For US Markets: Federal Register Q5C For European Markets: European ICH Q5C For Canadian Markets: Canada Q5C_E Stability Operations
Author: Terry Schindeldecker of Abbott Laboratories Inc. Published in the Manufacturing Confectioner, October 2000 The Manufacturing Confectioner Click to download PDF The Test of Time: Satisfying Stability and Photostability Requirement
Author: Bob Dotterer, Application Engineer, Caron Products Published in the Pharmaceutical Formulation & Quality in February/March, 2001 Pharmaceutical Formulation & Quality www.pharmaquality.com Click to download PDF You will need the free Acrobat Reader to view and print PDF documents. Click here to download a copy. |
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