A 16-page, color brochure describing an eight-step approach for rapid development of stability-indication methods has been released. This brochure includes information on a Method Development Kit, which includes four columns and a “how-to” handbook, for drug development scientists looking for proven methodology for creating stability-indicating assays.
These assays accurately quantify active ingredients in drug products without interference from degradation products, process impurities, excipients, or other potential impurities. Waters Corporation developed its approach on International Conference of Harmonization (ICH) guidelines for registering pharmaceuticals for human use.
Orders for the four-column Method Development Kit (Part # 186001100) can be placed (in the U.S.) at 800-252-4752 or with any international Waters office. Requests for printed copies of this brochure (Reference Code: 720000345EN) should be directed to info@waters.com.
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