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L ISTEN D OODLE V ISUALIZE P RESENT C ONCEPTUALIZE R EALIZE

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3

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Hygroscopic Substances 1 4

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2 5

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2 3 15.0 6

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Hygroscopic Substances 2 3 15.0 4 7

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Hygroscopic Substances 5 4 2 3 15.0 8

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Hygroscopic Substances 4 5 2 3 15.0 6 27.2 9

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Hygroscopic Substances 4 5 2 3 15.0 7 mobile phase + antioxidant 10

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The Allegations Plaintiff Has Made 11

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The Allegations Plaintiff Has Made 12

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HPLC PumpInjector Detector Analytical Column Guard Column 13

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10% 100% 15 mg 100% 1.5 mg 0.15 mg = 1% DTX-14

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HPLC 0 Retention Time in min 1015 50 100 150 15

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HPLC 0 Retention Time in min 1015 50 100 150 16

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Plaintiffs Did Not Test All Versions Version 0 ManufacturerInnovative Input125% February 2012 February 2013 April 2013 Version 1 ManufacturerNHK Input125% Version 2 ManufacturerNHK Input137.5% Version 3 ManufacturerNHK Input 137.5% Stabilizer added October 2013 2014 17

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Plaintiffs Have Failed To Prove Potency Is False Plaintiffs EvidenceVirtus Evidence No Testing Versions 2 and 3 Own Lab, Wrong Tests Inputs Show Accuracy Certificates of Analysis Show Accuracy Allay Testing Shows Accuracy 18

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Reference Standard Analogy + 19

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L-MethylfolateWater Powdered Tablet Allowed to Oxidize and Absorb Water 20

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