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`I § J-. 7 i °]_~
`REF
`'-- µ
`-
`
`q
`
`Equipment:
`Coming Stir Plate
`Advanced Micro-Osmometer 3320
`Laminaire horizontal flow hood
`Balance-Mettler 8240
`Balance-Sanorius LP6200S
`pH Meter-Orion350
`
`room:C 125
`room:C125
`room:C125
`room:C 125
`room:C125
`
`Asset# 000519462
`Asset#: 13324-00
`Asset#:A0129
`Asset#: A I 721
`Asset#:Al722
`
`Formulation:
`
`AL-37807 Vehicle at PH 5.5
`with Zn Chloride & PrOP. Gl Y •
`FID• 112286
`BATCH• 0?-47249
`lfl)E1 6-FFR-07
`EXP• 6-0CT-07
`STORAGEi RT
`
`Compounding Procedure:
`
`250 mL batch size
`
`I. Tare weighed a clean 400mL pyrcx beaker with stirbar .
`2. Added 80% batch quantity of purified water and began mix.ing .
`3. Weighed and added Boric Acid, Mannitol, Propylene Glycol, and Zinc Chloride.
`4. QS'ed to 95% with purified water .
`5. Stirred until completely dissolved
`6. Checked initial pH and recorded on batch sheet. ~= ~
`'5, $
`with IN HCI and/o IN NaO
`. Amount used
`7. Adjusted pH to
`8. Qs'ed to 100% with purified water.
`9. Mixed until homogenius .
`JO. Filter through 2-150mL 0.2micron Millipore filter units .
`( l 50mL in one for PET and IOOmL in the other to store at RD
`I l. Moved to Laminaire Flow Hood for remainder of batch preparation .
`12. Removed a small amount for the following tests:
`13. Final pH pH= ~. 5 (.
`14. Final tonicity Osmolality=
`~'-3
`.S:-" I .,f ,'4> .....
`c-i ,.., r
`I .'i. Visual Observations=
`
`0 . ()~l...5
`
`Submit D7 - ~ 7">-"( 'j for PET Screen:
`
`I. Submit a copy of the Batch Report, an FID sheet and the AR along with the sample .
`o,,.,._ .. +
`Submission ID number: I OflO'}" LI-/
`I So-I
`- -----·
`
`I oo ~
`
`• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •
`
`CONFIDENTIAL – PROTECTIVE ORDER MATERIAL
`
`I
`
`(cont. on page
`
`.g -.el
`
`)
`
`Date
`'1-t:.-o)
`
`ALCON 2015
`Argentum Pharm. LLC v. Alcon Research, Ltd.
`Case IPR2017-01053
`
`

`

`• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •
`
`J
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`NO: 13292
`BOOK
`TITLE J-1-:k., AL-17J'o/
`
`(cont. from page. ~ htr/.- )
`
`PAGE
`t:> J1 t....5 PROJECT #
`
`j
`
`NO: 39
`..:;.~s b q 2.
`
`Equipment:
`Coming Stir Plate
`Advanced Micro-Osmometer 3320
`Laminaire horizontal flow hood
`Balance-Mettler B240
`Balance-Sartorius LP6200S
`pH Meter-Orion 350
`
`room:Cl25
`room:Cl25
`room:Cl25
`room:Cl25
`room:Cl25
`
`Formulation:
`
`Asset# 0005 19462
`Asset#: 13324-00
`Asset#:A0129
`Asset#:A 1721
`Asset#:A 1722
`
`AL-37807 Vehi cle at PH 6.5
`with Zn Chloride & ProP. GI~ .
`FID• 112287
`8ATQ-i1 07 -47250
`MR)E: S- APR-07
`EXP1 6-C:CT-07
`STCRAGE• RT
`
`Compounding Procedure:
`
`250 mL batch size
`
`I. Tare weighed a clean 400mL pyrex beaker with stirbar.
`2. Added 80% batch quantity of purified water and began mixing .
`3. Weighed and added Boric Acid, Mannitol, Propylene Glycol, and Zinc Chloride .
`4. QS'ed to 95% with purified water.
`5. Stirred until completely dissolved
`6. Checked initial pH and recorded on batch sheet. p~'
`Amount used o . >G. I)
`l, . 5
`7. Adjusted pH to
`with IN HCI and/or
`r NaO
`8. Qs'ed to 100% with purified water.
`9. Mixed until homogenius .
`I 0. Filter through 2-1 SOmL 0.2micron Millipore filter units.
`(I 50mL in one for PET and I OOmL in the other to store at RT)
`11. Moved to Laminaire Flow Hood for remainder of batch preparation.
`12. Removed a small amount for the following tests:
`13. Final pH pH= C..- S/
`:::J-G.5
`14. Final tonicity Osmolality=
`c I e !\C ~I ..J J... '<YI
`15. Visual Observations=
`
`Submit O 7 - '-1 72-S o
`
`for PET Screen:
`
`I. Submit a copy of the Batch Repon, an FJD sheet and the AR alopg with the sample.
`Submission IDnumber: 10001eo1 '+ ~
`( 1so-vJ ~.,lo...,.; ·.H,.i)
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