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1) Reaction Temperature (Procedural temperature is 25C) a) Temperature Plus (+5C) 30C b) Temperature Minus (5C) 20C 2) Reaction Time (Procedural Time is 10 minutes) a) Time Plus (+5 Minutes) 15 minutes b) Time Minus (5 Minutes) 5 minutes 3) Volume of Solution-3 added (Procedural 2.0 mL) a) Volume Plus (+0.5 mL) 2.5 mL b) Volume Minus (0.5 mL) 1.5 mL Acceptance Criteria : All the system suitability requirements must be met for standard variations in HPLC parameters

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