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`TRA VAT ANRA W MATERIALS:
`(see attached batch-record).
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`EQUIPMENTS:
`Mettler PG503-S Balance, # 1726 Room C218
`M'ettler PB 5001-S Balance, # A 1855 Room C218
`Orion 710A pH meter, ID: No.A1732 ,Room C218
`Filter Unit, 0.22µ,Lot No. H4AN70830, Exp. FEB 2007
`NUAIRE Biological Safety Cabinet, Unit #18068-00. Rm. Bl32
`Microosmometer # 00103389 Rm. B132
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`EXPERIMENTAL PROCEDURE
`'f- '~~'!- , 2 -C>o.,-........
`LN 9988:087
`FID 106039 Batch No 04- 36405
`
`Tare weighed a clean bottle with a Stir bar :Y+~ -tr Grams. Added purifed water to make about
`50% ofbacth weighLAdded Boric acid, Sorb11ol and Zmc Chloride stock solution.Stirred to
`dissolve these. Added AL06221/HCO40 stock solution. QSed with purified water to about 95%
`of batch weight.Stired and Adjusted pH 6.0 with NaoH. QSed to 100% with purified water
`Final Weight i,OO · 6 0 grams
`<+- 11.1-<><1-, 3 .1o p....,
`5L
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`Initial pH
`3 ·b"33
`Amount of NaoH solution= 5"· ""16~ (I r<.J
`Amount of HCL solution = rv-"'
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`Final pH 6 · ~ '2..
`Osmolality = l'fC{ .....,oSM
`The formulation is then filtered using coming filter unit with a 0.22 µm filter. It was capped in the
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`One bottles of lot no. o4- 36 40S--l....was submitted for PET test to Microbiology group.
`LIMSsubmissionnumber
`IDbOi'-1"'746
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`Date
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`• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •
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`CONFIDENTIAL – PROTECTIVE ORDER MATERIAL
`
`ALCON 2013
`Argentum Pharm. LLC v. Alcon Research, Ltd.
`Case IPR2017-01053
`
`