Challenges in Implementation of the Method for Determination of Ammonia in Sodium Bicarbonate

Maria Zuckerman, Aalytical Development, Global R&D, Teva Pharmaceutical Industries, Ltd., Kfar Saba, Israel (Maria.Zuckerman@teva.co.il)
Tanya Kleiman, Aalytical Development, Global R&d, Teva Pharmaceutical Industries, Ltd., Kfar Saba, Israel
Svetlana Ginzburg, Aalytical Development, Global R&d, Teva Pharmaceutical Industries, Ltd., Kfar Saba, Israel

Implementation of the ion chromatographic (IC) method for determination of Ammonia in the common excipient – Sodium Bicarbonate caused noticeable professional challenges.

Among them: contamination of diluent (water), glassware and various analytical tools with Ammonia; problems of quality of deionized water; issues with accuracy and precision and carryover, etc.

All the difficulties were timely overcome and, as a result, the method has been successfully verified and several batches of Sodium Bicarbonate – released.

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Abstract Reference & Short Personal Biography of Presenting Author

Maria Zuckerman is Analytical project Coordinator in Analytical Development laboratory at Global R&D, Teva Pharmaceuticals, Ltd. She is responsible for methods development for small molecules API and drug products in generic development at Kfar-Saba R&D site. Maria joined Teva in 2012 and, since then, is involved in development of different and complex projects utilizing various analytical methods and technologies. Maria holds M.Sc degree in Chemistry from The Technion (Haifa Technological University)