`
`‘
`
`sé
`
`-2:
`
`::
`
`-..~2E-'-:.‘."-.E;':.‘.’‘.
`
`
`.~3.".".%I"“-.-‘:$é!'."°
`
`F _
`
`»
`
`*
`
`‘-s....'...‘‘...-..‘
`
`I
`
`016
`
`Project
`~
`4
`_
`Continued fiom Page
`xi .
`é
`I
`’ _
`1‘E #33 at
`_
`.
`‘H #
`
`I:FI»IIIN!I§figlIl!HIIIII-ll-
`’
`V;'
`-
`0
`-I 2
`-
`-
`
`‘
`
`PhenylephrineIICl0phtI:almicSoIutiD!1
`u.5!3« 130
`Lo:#.-’Snm_,pIa#.' 5*-I-e.:‘l1{z.9g§ m15g'.e«m.—'3‘-
`$311!: (2.5E»‘!-
`ggggg no-{.2 :.<st:s'—~H-2.3‘
`3324?. Got.) .gg1§1'%-W%i
`USP Monograph: Phenylephrine HCE Ophthalmic sialuaim, omciat 6810112013 —: Ii30I2013
`
`'
`
`1-55 3
`
`Eg R
`
`USP Manngraph: Phenyiephxine RC1 Na53! Jefly, Officiai l}8f{m2l}!3 -1 1l3fiI2!}l3
`
`To determine the Phenyiephrine I-lydrochkxride assay levéls iii 111:: above lots.
`Balance:
`Model: _ £361 SIN:
`:.1*Hn54
`ealibramdweekly@daily@ % dne'@_&
`PH memn ‘'#_;.5'5«,, 5 E5;
`Model: W=
`ca1im:m@umearuse__1gL_oJ§_mibmmwimmsrus —2 J 4'-‘ ’-I"
`
`mmc :51calibralziondue_o_u[;gfit_{~_
`I4»Comm: 5m=
`
`'
`Fiow game:
`
`tau:-‘rt-Syn
`- V-:’~
`7} ~'U mum
`
`'
`lqjection vomme: 2:: [AL
`
`Run Time: 20’ min
`
`'
`
`Column Tenxparauue: Ambient Wavelength: 230 min
`
`I
`
`I
`- _'
`3
`
` emwm
`E) in ‘Water
`2)" Pheny]e1:E1ri11eRS
`3) Epinaphrineflimtatafifi
`4) sodium-1-ocranmiasliimata
`5} Phosphoricmsici
`5} Magma}
`
`Pflfiil’
`BXPWWR
`1.915%
`Mamgfircmrcr
`used-on {oiled I3
`687921024875
`Bamswazi
`_ Lj_,0F5113 ’ _"E!-_‘?':'Z-
`LL61’
`i?\‘t.i*£1«
`Lag»-.-51,13‘
`_fi3._E_¢_‘?o
`ILLS?
`Riswnzd
`glfga gmr
`a:.a.[1ui[;5
`*;s‘;*=:.i3.,.§5§ 1 admin
` _ § {$2
`an
`IS
`
`
`
`.
`
`,
`I
`I ' m,¢w
`
`pm.
`
`Ia» :4 L3
`
`I
`
`-
`
`‘
`
`II.
`II
`II
`
`I
`‘-
`
`-I
`II
`
`II
`-I
`II
`II
`II
`I
`IIIIIIIIIIIIIIIIIIII
`:9
`9
`{fig
`
`I
`
`Signed
`
`3
`Date
`
`'
`
`ead ajnd Understood By
`
`.
`
`.
`
`Date‘ .
`Signed
`PARAGON - EXHIBIT 2014
`
`0001
`
`Confirmed wt nextpaga _
`
`0001
`
`PARAGON - EXHIBIT 2014
`
`
`
`Project
`Vlflilllllfll,
`
`Continued fmm Page
`
`K
`
`-*
`
`'
`
`.5.’ _.
`
`3
`
`«' 33 ’
`
`.--= “=1
`
`1
`
`J3. C“ av-
`
`__
`
`.
`
`gm, 'koI(\./{3
`
`!
`
`Safuflom
`'
`_
`A) MobilePhase~ [Ext 590 mL af(1) + 50:} ml. ms) + 1.1gof(4)}. axlzixed__§_;_f3_Lof{1) and____i_;g___L of(6) and
`mixedwel}. Then added 2. 2-:'.‘«Hrg af(4) andmixed weli. Adjustedpflto 2363 witi1{5). Exp. 1: gig 2‘'5
`E} Diiuezrt — (50:50) _£‘g_.1.5_'-_I.. of(§} and _§;:-_?;§+_L of(6)m1d mixed wen. mijusted pi-11:0 §£__¢>_‘~gwish (5).
`Exp.
`:1
`Pbenylephrine Stock Standard— [Ex 20 mgcm) into a 19 mL volumetric flaskandQS’dwith{3}}. Weighed-'g—§_-_§.;mg
`of{2) into 3.
`14:: mi.volumetric flask. Dissolved a_nd.QS’dwith (B). Mixed.mp. ;a'IwZr3
`Phenyiephrine Working Standard m Pipfiéred 1 mi. (DZ: into $3.20 1211. voiumetris: flask. Dissolved and QS‘:i with (C).
`Zvlixadw-aIt{conuenh*atIen=~4i.1mgfmL}. Exp. 1o{|.J\-3
`
`c)
`
`D}
`
`B}
`
`Phenylephrine Resolution Workixlg Standard —— iEx: Pipetted it) mi. of(C) into :1 1601111.. volumetric flask. Added 10.0 mg
`.333) andQsna w]:11(g}}_ 'Pip$fl;e,d
`5'. CI ml.am?) intoa_fi_t_3v*mL volumetric flask. AMw ng of
`(3) andqsaawith (B) andmixedwell. Bxp. dL t<>{u>1t '3'
`
`Sample Pram-ation
`
`. 2.5% Phenylepln-fine Solution: Pipettsed 2.0 ml. ofsample into 2120!} 11114 vohtmeiric flask, QS’d with {B-) and mixed welt.
`
`‘File-11 pipetted 4.0 ml. eftlte above solution into a 10 ml. volmnelric flask, QS’s with (B)
`Ami mixed w&ll(om:c:sm1'ation = -43.3: n1gfmL)._Exp. 115 ng !'~'r.uL who it’:
`10.9% Phenylephriue Sointion: Pipertedlo ml. ofsampia into a200 ml. votumetric f1ask.‘QS’d with (B) and mixed well.
`
`-
`
`Then pipezted 1.0 ml. aftha above solution into 21 10 mL Volumetric flask, QS’s with (B)
`And mixed wall (noncefitraiian ='— -l}.1xng/mL).Em 105% “'3
`
`Aaagpsr:
`
`Date:
`
`jg} ‘£0 3
`
`it
`
`Befliewudfiy: My
`
`Hate:
`
`{DIM £33
`
`..
`
`0
`0 I
`‘i ' i j
`I‘.
`§ S_
`-'
`-
`
`‘gm’
`
`.
`
`J I II
`Read and Understood By
`
`_
`
`Signed
`
`\
`
`We
`
`'
`
`Czintinued on Page '\fi$
`
`,
`
`Willi:
`
`Date:
`0002
`
`-s.
`
`r*“~\
`
`_
`
`0002
`
`
`
`v..'.|gm‘.
`
`.1
`
`j
`§
`
`5
`2
`
`-
`
`
`
`
`
`.9E».:1c:cacu. Wca3 '-:1a%an
`
`
`
`.*’~x_
`
`
`
`
`
`samp!eNamei Va?
`j
`{HF}
`
`!
`
`_
`
`0.00
`
`MJh_ff,_
`‘
`-"”
`
`
`N"la!!£5g!§!!!!!-FE:
`111$ ,.
`‘ __
`set~retnoa:PnerLn2_1:i_1s119,iL____
`-
`..Nemrrj.
`Ma-thud Sat!
`Report mamas
`new
`
`
`o.oo
`
`
`Pherrylaphrina
`-
`1 ‘I injecz sampses
`gfiqutlibfium _
`.....-...—....h._..___.-...——..,..-..j_._..__—_.-_.—.-.——_.._............._ ....._.......—..-.——:..>... . ...._........-......_..-...r...1..._.._T_.__..
`{systemSuit 1*1't1E'[_" sjInjec§tsamp:es'
`irfienyisphsine
`§ my
`Diiuem
`320.0; ____1§_:n1ectsaT§rgs
`__
`Emenytepznriae
`_W_H
`_ -
`30.60
`‘ ResoIufioa1__l 20.6 i
`1 ‘ InjectSamples
`Phenyiephrine
`.
`
`'a.ueTi"::Z1"1'z7 Pé6T"é;EéEs_EmE”‘”w""m '
`pnenyeafimne
`'_""”"" W "‘”"*”‘”""_""""_"_”‘””+“”‘
`3: ll _.__..2 Irfi;-e:§amv1em..
`*
`§Pher:r:e.W=-=...---_.
`2
`*3 f5
`gusts-11510
`30.9
`2 :l1§<_aE§a;::3i:§§_h ____ EPhany)ephr1nem__
`:9 9
`§MS13»{fl
`.9
`_1:tjectSam’;_:12”s_m'__m_F_____"
`f__Phany1e1ahnrce
`gen 10 lstandard
`Jilr
`zgrngectsampkas
`'1-‘=hany:aphn'ne
`
`1
`
`1
`'
`
`=
`
`:;:.t;..; 1__;_.:a”«»;
`
`-1
`
`1.0
`
`'.an:mE
`
`:1-°__._..;
`
`.
`
`‘ .....:..-.r.--—-.-.‘—-.-. .-
`g s E
`mason 1.00060
`is
`"‘m.ra1;fe:;an.
`~10
`,....-,.‘fi‘1°_"J.1;P£???P°[
`
`'
`
`.
`
`
`
`L
`1%
`
`10MB
`
`J;;mzr=oM=s
`
`2
`
`‘
`
`i
`
`i
`
`
`
`
`
`IIIIIIIIIIIIIIIIIIII Continued <mPaaeI*
`
` ..-'..v.-
`
`
`
`
`
`..-.1-.a..-~..-....-..,.-;:-:.:..,u.-.5...-H‘..5.-3.;.'-.x-.-.-.
`
`
`
`
`'
`
`___h__
`__
`
`_
`
`_
`
`__
`
`E
`
`
`
`
`
`0003
`
`
`
`E,
`
`.
`
`Project
`._._.._.:.____.....-.
`'”
`1:3;
`Continued from Page‘
`4 l3 -' 3,3 _
`.3 ~-'--'* _='= n 18
`
`i9
`..
`.
`5'95-«if-hi
`IIII
`
`Pl:uucytcphrinuAssay
`
`Dam 1011:1113
`
`I)P20i‘.!~339
`Dam Packagetzls ‘
`Neat? s1tveofCa£§b1a:£ar9.‘Ju.e:G|f0SI2Gld
`HPIE Caultilieus:
`_
`was-snrmsymm #1
`Colman: Phenomena): Luna 511 Cm{4.<Smm xfififlnrrn :4 Sum} S\N: 5?36?.4—54
`Deiacmr: WaH>r$UV @ 230 am
`‘item Ru:5: 1.0%} Inuntirl.
`induction ‘Vanna: 20 KL
`Mnhilerlinsem 50:50 h1eOE-I:l-Igfi) with Li 1311. ofsodimn-1—oc1anesulfi:-hate
`WMm'sl’I'I31‘I:!:t# P{w1y!:phrin2_l3iDifl__Sys7_J5
`Phcu leriueficl ntdasfi
`
`in (H :5
`
`
`msmmx.
`
`.
`
`31
`0311;
`
`110
`V --=-
`
`II II
`
`
`
`
`Emmoic G-eluiafiw:
`R1813-H27: {(855-w3r9o¢436}*(o.1IJ2 mgrnL)*(2oo;2)*(10!-4)j= 24. I2 mgrm1..
`nrsia-ma: :(s1:1nn:9amsy»co.ao2 mgan1.)w;zae.eyr(;w:;;n9a35 mgbni.
`
`—
`
`"
`
`'
`
`s4msnmw:suva:agmnpnamaminswsay\1a1e1op1m;segMnaAssayImmsass
`
`
`Continued on Pas
`
`“"5,-3-I
`
`I
`
`Signed
`
`it: it
`
`Date
`
`Read and Understood By
`-
`
`Signed
`
`E
`Date
`
`0004
`
`0004
`
`
`
`
`
` -
`
`" 'F2&'pm-ten‘ by User; éustifi Srafriehaz {Sanaziuui}
`
`E’hTeny|§—>phrine Repggt
`Ffgieat mm’ F%:e11yiapIirIna_1 31b1?;Sys?;:J5
`
`,,.......-_-a.=u__...»_.._..___.._,.."fl
`
`
`
`fianpfsj-2 I-viafraé:
`S.é_'rrp'I<3 Type;
`was;
`inj3ét‘s.3'nM#;
`lnjefiéipn VDIUF?’Ef
`Run ‘I‘:rr'e:-
`'
`Sarrgala SE1‘
`
`
`Sléridarfi
`:1
`
`fii
`3
`29.00 ul
`'
`SDI). l‘«Iir1'uE_e;~3
`Hfiéaiyfaphfir:-3_j§3-1B1?b_J_S
`
`fiéqiliréd By:
`State Acquiraci:
`Acq. Nletiwd 5&2,
`ate: Fat:-._:i;-_§s'e:d:
`F-‘:’If::£f:;F3E._5§i'ig Iiiggfhréfiz
`éiffannél bane;
`Efihrfi
`l3Ei'$GJ‘.:
`
`f3ar’u3§3;¥u1
`€16.51 ?i2{)1;3 5:26:21] W
`H128-‘yiephfiné
`IEI1 $12313 9:46-.93 AM
`F§1gnyEep!?;riné E
`484
`'
`
`5
`
`..._“.r :
`
`
`J
`-’~—.‘-.—'7
`\ g—-¥—* =WJ* ,
`--T’-5'-F
`2.13:3 mu
`E_‘».{_’:-.‘_i
`3,13%
`tam;
`
`1<t=:.fi4}
`
`.
`
`'
`
`$6 flit
`1-wt;
`Wunuéeg
`
`Ema:
`
`
`
`
`
`,_
`K fie-~w ‘["-Ha$+r1_—1“1 .
`,
`29.1313 Ema
`2-mi)
`Efim}
`zam 33050
`
`WE
`
`Phermyaaph:ii:rL'e
`
`
`FEa‘Khiar1"i?
`01Eai.ne;':nr0ms
`
`' RT
`553:2"
`
`Hafigdhi Aizea
`
`2' F‘fiE;fi1;PEEPhfln§.: 8.432 '-Eaafié 335556 _
`
`‘EH41-:§.':(:'01’.‘§a;;3!Ira.;1;1%ei’s
`
`
`
`I
`00 0:vi0ai}.;%aai;a%.ééé9;ii»a‘~:§?»i§%;:§=:é
`0
`liiage‘ ?3§a
`
`0005
`
`0005
`
`
`
`
`
` Phenv'ephrin% REF?9??
`w______
`Justin Sanéchez [Sa‘na:i1J1.;1}
`Ffp§ef:{f\|afi‘BT' Phehyiephtinemiaiei?_Sys?;.1S
`
`
`Reparteci by User:
`
`03AMF#E0*NF9
`
`EMATEELM
`
`_Sanpre )‘}$arre:-
`_Sé§n1:Ia Ty ‘pa:
`Wat
`1njecztan_#:
`lnjectirm ‘doturrvé
`Run fine;
`0
`Sanfife S=;e§i_!§£}an*e:
`
`$_E3f3C!3f‘(i
`{Jrti-mw n
`5
`2
`29.05‘; ul
`3&0. Mn'u£s35
`F?1e:nvf£*phr'ir:-:i_*t-3-1t31?_._,J‘$
`
`Acquired By:
`Date Acquired;
`Acq-. Nefiwiid $8!‘
`{me F’rc_a:i:—;s$_'ed_:
`H‘r§_¢e§ fng Efiafladd:
`§_‘-'h_':3nnz=;I1__r~1an*g:
`Chm Desrsrz:
`
`'San-Ghéui
`'H1f1?*!2§13i§:2E3§:-2i) PM
`Flaenytephrinfi
`:¢:1s:2:313 9‘-4e;¢;.n AM
`Fifzgnyiaphrinté 3'
`1584
`'
`
`
`
`
`
`.
`
`2000
`
`22.00
`
`24.00
`
`’r"""'r”;_“‘1-"T.-—r—rv-'r"'-.--"=5
`
`303353
`
`28.00
`
`33,59
`
`m0000W%W0000
`
`
`
`”‘i"."1""""I”"”‘l“"‘I"‘—]""?*“"""""“' W=’<--“-ff%rT*?~*%
`F-400
`?;§fi
`8;£!€.‘f
`B,'5£3
`'9,
`Eefinutég
`
`:-
`
`.
`_
`r“"]Mw “i~WwWW*Tfr¥fi#' '
`,
`»
`.
`~«———%
`13.00
`9 59
`H5. 50
`H‘: §D
`
`5 RT gfiéighti Area f
`:=eag.:n;an:;
`_
`:5."i-'5i3‘s3_§
`:
`:
`Efiineifitarine
`: 20 F1'*u3_fiylep}1'rlna 3 3,432 5a4r;i§. : 335585 f
`
`
`
`Hepor:a,aaiE§'§ki:
`
`'fifienyrepn:?:ne¥.ee.
`
`
`00
`0
`'
`Fri-n1.-éga 9:4$;§3AM_0 1jo
`'
`' "
`Péga: mm"
`
`0006
`
`0006
`
`
`
`
`
`Ph9“Y'eDh"fl§BRPJ
`
`Frqéect Narré; F11enylephrinE_131D17m$ys?,,}$.
`Justin Sanchez {Sanch._Ju1)
`Repnrted by User:
`
`
`sjan1:ate'Na'niz;-r
`‘Semis Ty pg:
`Via!
`Inj'a'.r;_u::n 1::
`kzjeqflon Voiumi.‘
`mm Tune:
`Sarmie Set-fsie'.1:T'e'
`
`-
`8antI:hJui
`Afiquirad By;
`Spikedw Ssisgfiér
`1fiI1?i2€313'6_:05_9f4$ PN1
`Data Acquired:
`Lhw-knew :1
`Hlenyraphriné
`Acq. Meifiad Seat‘
`7
`101156201 3 9;_4$:4-5 AM
`Data: F’rcscessed.:
`1
`F_E1eny£a'phr'ina 8
`Prg¢’essing Mefihczgd;
`20.60 2;!
`434'
`Qiwanner r~,ién‘a:
`33.0 Mnutes
`ighnl Cx=._ésr;r;."
`H1erjsylephrine_131D.1 ?"__JS
`
`
`
`
`
`
`lflhenyiephrééne«.B.45ff
`
`
`" ""”'+ Ix I
`E
`L
`J" 113
`I__.
`3 3"":"“% ?'”§'“ T"'f "* ;F “’!‘”T“?’§
`V-MK}
`3.94}
`30135}
`13.59
`11.00 M
`05.00
`18,110
`29133
`2-253$
`2-‘$.03?
`'$E.i§'i}
`'25J)v’.‘!
`M30111 $33
`.==.-..==-_._.j—j-——,—‘.~:~.-.,.-_..__.____.¢.-,q:__.__._._.0._. ,,‘._____._r_0__‘_M___"___j,_____.,,.,.___.,_ ,.__,__,,,,,,_,_,,,_.,,.,_..._
`
`
`
`_
`_
`_
`‘g ‘
`.
`.
`--"-=W°{—r~e-"""_v"~*"7"”"?»*+~r*j***r*“"“:”“**r“*"’r"— -g
`,
`.
`.
`,
`.
`3.5:;
`am;
`ma
`u-ma
`13.55
`_ H H
`i‘.%‘£'m_!i.°;$
`0 RT T9:-eight: Ereg 0_
`' Peafihiarra
`5353:; i;
`4
`.j
`.1.E3:\inE;;_nhrine
`2 2 90 Pitehylephfine 51451 sacra-g 392363 A-
`
`
`
`Report i»}sc_«t'm.-.».'-i-. Pné{{yieprmneA
`
`
`p;me;g"§,45;45 AM" =::ma:'2<313
`'
`I
`I=ia'g-Q1 of’!
`
`0007
`
`0007