`
`MYLAN INST. EXHIBIT 1127 PAGE 1
`
`MYLAN INST. EXHIBIT 1127 PAGE 1
`
`
`
`T H E
`M E R C K I N D E X
`
`AN ENCYCLOPEDIA OF
`CHEMICALS, DRUGS, AND BIOLOGICALS
`
`TWELFTH EDITION
`
`Susan Budavari, Editor
`Maryadele J. O?Neil, Senior Associate E d i t o r
`Ann Smith, Associate Editor
`Patricia E. Heckelman, Assistant Editor
`Joanne F, Kinneary, Assistant Editor
`
`Published by
`Merck Research Laboratories
`Division o f
`M E R C K & CO., INc.
`- W h i t e h o u s e S t a t i o n , N J
`
`1996
`
`MYLAN INST. EXHIBIT 1127 PAGE 2
`
`MYLAN INST. EXHIBIT 1127 PAGE 2
`
`
`
`:
`
`:
`
`;
`
`°
`
`¢
`
`ity
`
`-
`
`i
`
`ic
`
`wi
`
`2,
`
`ing
`
`point
`
`de;
`
`itive
`
`in
`
`thi
`
`-
`
`.
`
`.
`
`?
`
`|
`
`Isotonic Solutions
`The following table provides data for adjustin
`¥
`of aqueous soluti
`ig the osmolality
`i
`i
`normal saalat d e p r o n
`o n g )a n d therefore isotonicwith bloodand tears.This?canbe achiovedbreseamatic wthe
`freeziTE e o ad o eperimentall
`or
`© sodium chloride
`equivalent method. The freezing point depression values have
`suivantval Hes, ia italics, re heen
`~ The top values listed for eac!cherhicel areNoch yur de e e
`point depres
`the second values, in italics, are
`point depressi
`freezing
`values' r acerees Celsius.The percentage concentration (w/v) at isotonicity is given in bold face in the ast column. non
`v a s n O s% e e Pome gebression,methoda n isotonic solution is prepared bymatching the freezing point depression
`Hee fo make a2 Hepes buf sluion i s o nAES a B a a s eee
`Om COREE g e
`i
`,
`;
`Freezing point depression of isotonic solution
`0.52
`Freezingpointdepression of 2% Hepes
`from table
`0.163
`Difference tobe supplied by Natl
`0357.
`0.9% NaCl has a
`freezing point depression of 0.52
`x% NaCl hasafreezing point de mession of 0.357.
`x/0.9
`Therefore
`= 0,357/0.52 - -
`x = 0.618
`Thus 0.618 g/100ml NaC] combined with 2g/100ml Hepes produce? an isotonic solution. Note: If more than oné component
`is in solution the freezing point depressions of each must be added together before the difference value is obtained.
`Using the NaCl equivalents me' od to prepare a solution involves: Multiplying the number of grams of each component
`fromthe, table at the nearest listed concentration. For example to make 60 mil
`corrected for volume by its NaClequivalent
`NaCl equivalents of each solution component.
`of 1% boric acid isotonic: Add the
`e e
`60 ml of 1% boric acid soln (0.6gboric acid?x 0.5g NaCl equiv.) =-0.3g
`Calculate the number of grams of NaCl required for'the volume being used. (60 ml need 0.54 g) Subtract the NaCl
`equivalents of the components from the total NaCl required. (0.54 -.0.3 = 0.24g) The difference is the amount of NaCl
`the difference is less than zero then the solution is already hypertonic
`which must be added to that specific volume. Note: I f
`and cannot be adjusted without altering the concentration of the components.
`
`-
`
`.
`
`.
`
`Sodium C h l o r i d eEquivalents and Freezing Point Depressions (°C)
`. . *
`f o r Certain Concentrations (w/v) of Solution
`
`oe
`
`1%
`
`o r
`
`QUO.
`
`e e
`
`wo
`
`0.5%
`
`:
`
`Chemical
`Acetrzoate methylglueam
`
`Acerizoate sodium
`
`yo
`
`=
`
`Acetyleysteine
`
`.
`
`Actylulfanlamide sodium
`:
`
`Actifevine
`
`Adenosine phosphate
`
`Adrenalone hydrochloride
`Mote
`Alcohol, dehydrate
`Alum, potassium =
`Aminacrine hydrochloride
`
`7
`
`Aminoacetic acid
`
`Aminocaproie acid
`F
`O
`
`|
`
`:
`
`8
`
`(
`
`wo
`
`,
`
`4
`
`?
`
`_?
`
`_
`
`_
`OS
`
`tA
`
`_?
`
`_
`
`638
`
`Ne
`
`.
`
`0.76
`
`o e
`
`058°
`
`j a e
`
`_
`
`032"
`
`e t
`MISC-47
`
`Concentration of Solution, NaCl Equivalents
`?At Isosmotic
`Concentration
`
`2%
`
`3%
`
`5%
`
`ue
`bre oe Oo Inae
`O
`gua ow,
`?G18;
`oes
`4g,
`f30
`970, 93 93,
`=
`AE
`20,
`(ihe
`(OG OR BS
`BRE
`1 8
`fue bie Oe
`_
`aye
`O41,
`BDe 5 |
`Ome
`OTT
`0B,
`=
`og
`_ , O e 1.28%
`_
`0
`Oe
`_
`RD OTROS OR a t
`Os!
`o e
`_
`?
`_
`OF.
`O e
`o f .
`_
`O e
`Oe
`
`MYLAN INST. EXHIBIT 1127 PAGE 3
`
`MYLAN INST. EXHIBIT 1127 PAGE 3
`
`
`
`?At lsosmotic
`=
`?
`o 7
`QS2
`Ose
`
`Ww
`
`?-asP
`D
`
`me +
`
`?_
`
`<
`
`~ w s <<
`
`ioatenteSubations(Coanieed)
`?
`?
`
`?
`
`?
`
`?
`
`|
`
`.
`~ ,
`
`:
`
`\
`
`4
`
`Geescal
`e a
`
`P Ammnelige
`i
`p-Assnesaiccyiaae
`e
`
`soem
`e
`;
`Ammonsemchlorite
`.
`Ammmoniem b a t e
`
`.
`
`-
`Asumomam phospicat,
`Ammon seliic
`
`?
`
`.
`
`Autimony
`
`potassiam
`
`tartrate
`
`_
`
`Autipyriec
`
`?
`
`Amrcolieep c o s :
`_
`Arginine slotamate
`:
`LArejni
`Arginine lydrocblonide
`e a e
`Arsenictioxide
`i acid
`Ascorbic
`sne methylnitrate
`Atropine
`
`Atropine
`
`soe
`
`sulfate
`
`Aurothioglucose
`
`sodium
`
`arbital
`Barbital
`Benzalkonium chloride
`,
`
`Benzethonium chloride
`
`Benzyl alcohol
`
`Bismuth potassium tartrate
`
`$s
`
`Bismuth sodiumtartrate
`
`MISC-48
`
`? .
`
`.
`
`-
`
`?
`
`e
`a s
`
`*
`=
`?
`
`?
`?
`?
`C
`
`?
`-
`
`_?
`
`?
`o F
`n
`_
`-
`=
`_
`-
`? -
`
`?_
`?
`
`l
`
`C
`
`e
`_
`
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`
`e n<
`~
`?
`_
`_
`030
`OF.
`| ?
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`l
`_
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`O15
`
`ose
`YE)
`e s
`.
`0 2
`0
`1
`y e
`a n
`o n
`a w
`axar
`?
`1.10
`?
`a x
`o s
`403
`a f
`o o r
`O m
`a n r
`058
`055
`a r
`o e
`oa?
`_
`_
`055
`055
`_
`_
`a n s
`03sr
`052°
`?
`a 8
`0 2
`010
`013°
`OM
`= 013
`0 1 7 .
`o w .
`O14
`0166
`O29 - 03% O 5 2 .
`G17
`.00F
`o o r
`OH
`0 B
`- 027?O02S
`ggso.
`O52
`O4P
`?
`Ole
`f e r
`«028
`0 0 1 7 ? 0 T ? s i T ? i t i T s O L T
`9
`O27
`048
`052
`«O1F
`001%?
`84007
`030
`?
`031
`«(028
`«(0.27
`aoe
`O I
`o u r
`03F
`OAR
`?
`030 © 0.30
`?
`?
`?
`00Er = 0.1?
`?
`?
`?
`_?
`018
`0 2
`O18
`O18
`Ooo
`0 0 7
`02°
`03°
`801°
`B
`G
`O18
`020,
`005°
`026
`01°
`014
`O13
`007°
`0.037
`0.03
`0 0 r
`030
`O17?
`
`0
`o r
`oar
`.
`
`O3r
`
`o o r
`_
`
`Ose
`
`ose
`
`0 2 .
`
`S
`
`O11
`O19
`0.03
`o o f
`
`O50"
`
`0.14
`02e
`0.
`OOF
`
`O e
`
`o t e
`0.1
`01F
`
`§=«ogie
`
`oote
`
`o o r
`
`_
`
`o s .
`
`a
`7
`=
`
`«=
`
`tL, = 0.10
`O52
`O3P
`
`0.03
`ooo7
`032.
`0.087°
`
`016
`0.18
`0 0 K = 0OP
`0.08
`0.05
`0022
`OOP
`017°
`0.18
`00"
`0.04"
`0.10
`0.09
`003°
`«005°
`0.14
`o o r
`
`0.13
`60bT
`
`O12
`O1F
`
`0.03
`00r
`029
`037
`O15
`OIF
`0.03
`0 0
`0.16
`0.18
`0.07
`0.08
`0.13
`«ole
`
`MYLAN INST. EXHIBIT 1127 PAGE 4
`
`MYLAN INST. EXHIBIT 1127 PAGE 4
`
`
`
`Isotonic Solutions (Continued)
`Concentration of Solution, NaCI Equivalents
`At Isosmotic
`?5%. ? Concentration
`?
`19%
`O47
`O52 =
`119%
`?
`?
`0.27
`052°
`_
`?
`?
`?
`0.53
`052
`036
`052%
`
`1%
`#050
`028
`O17
`0.10:
`0.27
`015°
`
`0.5%
`052.
`014°
`0.20,
`0.067?
`0.27
`0.078
`
`2%
`?
`?
`O14
`O18
`0.27.
`031°
`_
`0.08
`0.08
` ?
`0.04
`0.02°
`0.27
`0.30
`0.23
`020
`015
`0.091?
`_
`9.50
`0.51
`O14?
`?
`029%
`0.34
`035:
`0.36
`020° O04
`0:097°
`_
`0.70 :
`0.70
`= ?
`0.200
`«860040
`021.
`021
`021
`@06I? «= 0.12?
`
`0.07)
`020
`?
`?
`_
`_
`?
`?
`_
`?
`?
`?
`?
`?
`?
`
`0.70
`052
`. 020
`O S
`_
`?
`?
`?
`?
`0.20
`? ? s « S
`?
`?
`?
`_?
`?
`022:
`OS®
`?
`_
`?
`?
`0.16 .
`0.52?
`_
`?
`
`3.33%
`333%
`
`1.70%
`1.10%
`25%
`25%
`1.29%
`1.29%
`4.50%
`4.50%
`
`4.5%
`45%
`
`41%
`41%
`?
`_
`
`. 5.52%
`5.82%
`
`Chemiemical
`
`Boric acid
`
`promodiphenhydramine hydrochloride
`
`putabarbital sodium
`
`Caffeine
`
`Calcium aminosalicylate
`
`Calcium chloride dihydrate
`
`Calcium chloride hexahydrate
`
`Calcium chloride, anhydrous
`
`Calcium disodium edetate
`
`Calcium gluconate
`
`:
`
`,
`
`Calcium lactate
`
`Chiniofon
`
`7
`
`Chloramine-T
`
`Chlorob
`robutanol, hydrated
`
`Chi
`
`Srophyll
`Cittic acid
`
`Co
`ongo red
`
`,
`
`oo
`
`ge
`
`.
`
`.
`
`-
`
`a
`
`Cro
`
`.
`molyn sodium
`
`Cupri
`
`Pric sulfate
`Cupri
`ric sulfate, anhydrous
`Cycloph
`Phosphamnide
`
`Dextr
`
`me
`
`Dex
`
`tose, anhydrous
`
`Diatri
`mizoate sodium=
`
`,
`
`.
`
`-
`
`2.
`
`?
`
`.
`
`|
`i
`
`-
`
`.
`
`-
`
`.
`
`3%
`?
`_
`010
`018
`0.27
`0477
`_
`_
`0.21
`038
`_
`?
`_
`?
`?
`_
`0.20
`B S
`0.16.
`0.14
`0.15
`0.18
`0.28
`« ( 0 . 0 9 . 1
`050°
`026:
`023
`021
`O22
`0 2 0 3 7 2
`9073
`0.14-:
`0.12
`0.11
`0.13
`O20
`013
`0:03
`007°
`0.22
`0.22
`0.23
`0,24
`0 . 2 0 3 8
`9064 «= 0.122.
`?
`?
`?
`?
`0.24
`_
`_
`?
`~.
`0.071°
`0.14
`0.08
`0.10:
`0.05
`0.06
`O e
`i 0 0 8 ?
`9.037?
`?«00S®
`018
`016
`O17
`O18
`0.17
`0.050 © 0 . 0 = 0.1
`0.28 = 047°
`0.05:
`0.05
`005
`0.05
`0.05
`«0.0
`001s
`0.0
`l S
`003°.
`009
`0.16
`0.14
`0.05
`O11
`0048
`O15°
`«=O.
`«0008
`0.20
`016
`0.14
`0.18
`0.09
`0054
`017°
`0.39%
`0.27
`0.30
`?
`0.25
`O e
`O e
`(028
`0.10
`0.10
`0.10
`pose 6 00e
`O I
`016
`016
`O s s
`«00 «=O.
`018
`O18
`O18
`-
`g l o
`(020???(03I
`OTB
`09
`(0.09
`©0009
`o e
`«01
`0.09
`
`~=?«0.132
`
`O15
`0.25
`0.23
`«(03
`_?
`
`016
`
`=?«0.27°
`
`~. 6.85%
`6.85%
`4.09%
`4.09%
`
`O13
`052°
`0.22
`S P
`_?
`
`_?
`
`016
`052?
`0.18
`052"
`
`016
`«(047°
`018
`OSI
`(0.09
`(0.09,
`0.28 = 052°
`
`~
`
`5.51%
`5.51%
`5.05%
`8.05%
`*. 10.55%
`10.55%
`MISC-49
`
`O O
`
`MYLAN INST. EXHIBIT 1127 PAGE 5
`
`MYLAN INST. EXHIBIT 1127 PAGE 5
`
`
`
`Isotonic Solutions (Continued)
`Concentration of Solution, NaClEquivalents
`At Isosmotic
`Concentration
`0 3 1 ,
`2.90%
`= 0.52
`2.90%
`2.16%
`2.16%
`
`Chemical
`
`Diethanolamine
`
`Dimethyl sulfoxide
`
`Disodium edetate
`
`Dopamine hydrochloride
`?
`
`Ephedrine hydrochloride
`
`Ephedrine lactate
`
`Ephedrine sulfate
`
`,
`
`Epinephrine bitartrate
`-
`Epinephrine hydrochloride
`
`:
`
`/
`
`Ergonovine maleate
`
`Ethylenediamine
`t o o
`Evans blue
`
`-
`
`.
`
`:
`
`4
`
`he
`
`?
`
`Ferric ammonium citrate, g r e e n . . .
`o s
`tes
`Ferric cacodylate
`-
`
`.
`
`:
`
`.
`
`Ferrous gluconate
`
`*
`
`aan
`
`05%
`0.31
`0:08"
`
`0.42
`0.122?
`
`?
`
`1%
`031
`017°
`
`0.42
`0.24" =
`
`0.24
`0.070°
`
`0 . 3 0
`0.085°
`
`0.32
`0.087
`0.28
`0.075°
`
`0.24
`0 0 7 °
`0.18°
`0.050°
`0.30
`0.088°
`0.20'
`0.055°
`0.46
`0.130°
`.06
`0.017°
`
`0.23.
`0.13°
`
`0 . 3 0
`0.17°
`
`0.30
`0.10?
`
`0.26
`0.14°
`
`0.23
`013%
`
`0.18
`0 . 0
`0.29.
`018°
`0.16
`0.08°
`0.44
`0.25°
`0.06.:
`0.03?
`
`*
`- .
`
`os
`
`a t
`ce
`
`.
`
`i
`
`.
`
`os
`
`a
`
`?
`
`4.44%
`4.44%
`
`3.11%
`3.11%
`
`3.2%
`3.2%
`3.72%
`3.72%
`4.54%
`4.54%
`
`5.7%
`5.7%
`?3.47%
`3.47%
`
`2%
`031
`O 0 3
`
`0.42
`0 , 4
`0.22
`0.24°
`
`3%
`?
`?
`
`?_?"
`_
`0.21
`0.38°
`
`0 . 2 9
`0.33°
`
`0.29
`0.50°
`
`0.29
`0.33?
`
`0.25
`0.28°
`
`0.22
`0.24
`0.17
`0.19"
`0.27
`0.31°
`0.13
`0.14°
`0.43
`0.50°
`0.06
`0.06°
`
`0.28
`0.48?
`
`0.24
`0.42°
`
`0.20
`035°
`0.16
`0.28°
`0.26
`0.43°
`?
`?
`?
`?
`0.05
`0.09°
`
`| 5%
`?
`?
`
`_?
`
`?
`
`_?
`_
`
`_?
`_?
`
`?
`_?
`
`?_?
`?_?
`
`?
`_
`0 . 1 6 . . .
`0.45°
`?
`?_?
`
`?
`?
`
`_?
`
`?
`0.05
`0.14°
`
`0.14
`0.39°
`
`?_?
`
`0.42,
`0.52
`0.20.
`0 . 5 2
`
`0.29
`0.52
`
`0 . 2 8
`0 . 5 2
`0.24 |
`0.52
`
`0 . 2 0 .
`0 . 5 2
`0.16
`0.52°
` . 0.26
`0.52°
`=>
`?
`?
`?
`?
`_?
`
`? '
`_?
`_
`?
`?
`_?
`
`0.18 \
`0.054
`0.10
`0.023°
`0.16:
`0.048°
`0.22:
`0,062
`
`0.36"
`0.09"
`
`o o r
`
` @.
`
`0.06 .
`0.013°
`O18'
`0.050°
`
`0.18
`0 , 0 5
`
`0.05
`0.015°
`
`~
`
`:
`
`~
`
`:
`
`2
`
`,
`
`>
`
`? 0 . 1 2 ,
`0.037"
`o t e
`°. Ou0°
`049
`
`w e
`
`?
`
`0.17:
`0.09°
`0.09"
`0.04".
`0 1 5 °
`0.08°
`021
`0.127
`
`0.31.
`0.18
`
`L
`
`0077
`
`0.05"
`°
`0.02°.
`018°
`.
`0.10
`0.18
`0 1 0
`0.05
`0.03°
`a
`0.12
`0.00
`
`=O.
`
`016
`0 . 0 8
`
`0.16
`0.17°
`0.08
`0.09°
`0.14
`O1S°
`0.21
`0.23
`
`0.29
`o
`033°
`
`0.05
` 0.05°
`0.18
`0.20
`0.18
`a 2 r
`0.05
`
`2
`
`0
`
`0.11
`0.12
`0.14
`1 °
`
`:
`
`:
`
`a
`2
`
`ot
`
`.
`
`oS
`
`F
`e
`
`lactate.
`
`e
`
`7
`
`Fluorescein sodium
`
`Lo
`
`Fluorourac
`
`Polini
`
`.
`
`Folinic acid-SF calcium '
`:
`p-Fructose
`
`ut
`
`|
`
`a
`
`Galactose, anhydrous
`
`Gentamicin sulfate
`
`_
`
`:
`
`.
`
`Glucoheptonate calcium
`ve
`
`Glucosulfone sodium
`_
`M I S C - 5 0
`
`0.15
`0.25°
`?
`?
`0.12
`0.2]°
`_
`
`0.27
`a 0
`947
`
`0.04
`04°
`0.07
`0.18
`F S
`931°
`0.18
`3
`0.05
`.
`
`(18
`
`?
`0.11
`0.33°
`_
`_
`
`?_
`
`?
`
`_
`
`0.27
`052°
`
`|
`
`3.34%
`334%
`
`0
`0.04
`0.12°
`
`_
`?
`
`0.18
`? @'5ze
`
`0.18
`0.522
`
`+
`
`5.05%
`5.05%
`
`492%
`g m
`
`:
`
`?
`
`0.05
`|
`
`1 0
`0.27°
`
`3 g
`
`.
`
`O N ,
`
`?
`
`?
`~~
`?
`
`?a50~?SCO
`
`0.10
`0.17
`0.13
`a 0 |Ct(«
`0.23
`
`MYLAN INST. EXHIBIT 1127 PAGE 6
`
`MYLAN INST. EXHIBIT 1127 PAGE 6
`
`
`
`I s o t o n i c Solutions (Continued)
`
`q
`
`035
`052
`U 4
`052
`~
`
`2.6%
`26%
`2,19%
`219%
`?
`
`_?
`
`?
`_
`_
`?
`
`0.09
`o l e
`_
`_?
`
`?S
`
`Concentration of Solution, NaC]Equivalents
`At Isosmotic
`1% =~? 2% =
`05%
`Concentration
`3% «=
`5%
`018
`5.02%
`0.20"
`020
`019
`018
`019°
`0.22032?
`O11
`052"
`8.02%
`OSIP
`0.061"
`0.25°
`?
`025
`0,25
`0.14°
`0.29°
`0.070°
`?
`?
`0.36.
`035
`0,35
`020
`O40
`?
`0.10
`e e
`044
`041"
`041
`0.23
`0.118
`947°
`?~
`010°
`/
`0106
`0.10
`~?0.09
`Ol?
`2 s
`" 0 . 0 3 2
`0.068
`147%
`6 5
`?
`072
`061
`052
`0.208 = 9.378
`?
`147%
`s«i007?si07?ti«éd22 2 ?
`0.07
`0.07 = 0.07,
`«0.07.
`1 2 ? ?
`= 0.52"?s«
`122%
`0.04"
`0021°
`0.08)
`0 . 1 4 0 1 3
`0 . 1 3
`O T
`0 1 6
`6.80%
`0.14
`80%
`0,048
`0.08"
`038?
`0.18"
`0.23?
`052°:
`0.40'
`040:
`_
`?
`0 . 4 0
`0.40
`2.24%
`04a
`?
`052
`324%
`"023°
`0:115°
`?
`i 4 % .
`0.25.
`024
`0,28
`0.22
`0.080
`0.14
`5
`g
`.
`027°
`?
`?
`0.30:
`0.29:'
`0.28
`018 = 03?
`?
`0082
`0 1 8 0 0 1 "
`_
`0.01,
`004°
`o l ?
`0.00"
`930°
`?
`(0.30%
`0.08 = I T ?
`016:
`016°
`0.16
`0.18
`0.047°
`0.09"
`1
`4
`O17
`0
`0 . 0 0 . 1
`0.055"
`O11
`O11
`O12
`O12
`0.06
`003°
`012
`0.14)
`O12
`0.06
`0.13
`0.035°
`0.03:
`0.03:
`0.03
`0.008
`0.03?
`0.01%
`9 5 3 - 0 5 3 )
`=
`030°
`0,153?
`?_
`0:07'
`0.04
`041
`a 2
`0.07;
`0.04.
`a
`
`.
`
`Chemical
`
`p-Glucuronic acid
`m
`L-Glutamic acid°
`"
`Glycerin
`
`:
`
`Glycine
`*
`Gold sodium thiomalatei
`ms
`Guanidine hydrochloride
`
`5
`
`Heparin sodium
`
`Hepes
`
`:
`
`-
`oo
`
`Histamine dihydrochloride
`
`-?
`
`|
`
`Histamine phosphate
`m
`Histidine monohydrochloride
`a r
`:
`Hyaluronidase.
`a
`i
`Indigotindisulfonat
`BOundlisulfonate sodium =
`
`-
`
`v
`
`-
`
`olodohi
`
`Ohippurate sodium
`
`lodophthalein
`Sphthalein sodium
`
`sodium
`
`lod
`
`*pyracet
`
`-
`
`BS
`
`We
`lod
`?*Pyracet diethylamine
`
`deectee.
`
`.
`
`/
`
`lopami
`Pamidol
`
`Iso
`
`Propy! Alcohol
`
`Kanamyei
`
`?mycin sulfate
`
`Lactic
`tic acia
`
`aciq
`
`Lactose
`
`Lith
`
`um carbonate
`
`Lithium
`
`cht:
`
`m chloride
`
`_
`
`7
`
`"
`
`7
`o
`
`:
`
`'
`
`ow
`
`a
`a
`so
`
`mo
`
`;
`
`a
`o d
`7
`-
`
`.
`
`4
`=
`?
`,
`
`,
`m
`
`os
`
`;
`
`,
`"
`
`0
`
`.
`
`/
`
`--
`
`h o
`
`?oa
`
`oo
`
`,
`
`2
`
`1
`3
`
`L
`von
`
`0.08
`0.021?
`44:
`p a o
`0.06.
`0.019?
`OG:
`e o
`140°
`040° 2
`
`0.23
`039
`0.26
`4 g
`Ss.
`0.0L
`0 0 2 i ?
`?
`?_
`?
`_
`015)
`O15
`026
`o44
`2
`OL
`03?
`0.21
`010
`O11
`018
`02%
`O11
`O11
`O I
`030°
`003: 6
`0.03
`0.05°
`0.08°
`?
`?
`?
`?_
`007
`O12
`?
`
`0.07
`O22
`?
`
`0.07
`0.08
`0.39
`ogee
`
`0.08
`0.08
`0.08" = 0.1?
`_
`oe
`=
`_
`_
`?-
`_
`?
`
`009
`024
`?
`?
`?
`?
`
`OUD
`
`_
`
`_
`?
`- O15. = 592%
`O52
`sore
`0 , 0 9
`9.58%
`8B
`0529
`0.10 ° - 9.21%
`052
` 9a41%
`g73%
`O10
`0S?
`873%
`
`=
`
`..1,71%
`1.71%
`
`_
`0.53.
`0.52°
`ne
`?
`+ 23%
`039
`B B
`ts«R,
`009:
`+ 9.75%
`052?«078%
`0.98.
`0.92%
`052
`092%
`140
`. 0.65%
`052
`065%
`
`MISC-51
`
`MYLAN INST. EXHIBIT 1127 PAGE 7
`
`MYLAN INST. EXHIBIT 1127 PAGE 7
`
`
`
`5%
`OOD
`
`ase
`f i e .
`a 4
`a n e
`a e
`
`.
`
`O H H
`1%
`m n
`009
`009
`o n
`I S
`aos
`«(ale
`_
`6 0 4 5 S
`?
`a m
`ase
`«06 )|= S
`O17
`aor
`al7?
`a 2
`
`IsetenicSolutions (Continued)
`Concentration of Solution, NaCl Equivalents
`At Is
`Concentration
`O R
`LOD
`°
`36%,
`9.65,
`OS?
`0 4 5 .
`2m
`s
`rug
`457%
`63%
`635
`31
`w h
`Say
`STN
`
`A522
`
`?
`?
`?_
`?
`O24 .
`052
`028
`O52
`+024
`05%
`0.24
`052°
`?
`_
`_
`_
`
`Babe
`
`?
`
`~?
`
`?
`?
`
`033,
`_?
`
`37%
`37%
`321%
`321%
`368%
`368%
`381%
`381%
`
`5.02%
`5.02%
`
`70%
`L e
`
`y
`
`3
`
`é
`
`>
`
`n s
`
`C e n a
`
`Lyapoletesoddesn
`.
`DMinguesiemechloride
`
`.
`Magersiem solfane
`
`.
`MMagnesiess selfane, anhydrous
`
`Masniol
`Mexbronnim
`
`Mescuniccyanide
`
`Mescarybichioride
`-
`Micthecholierbromide
`
`Medacholinechiotide -
`
`Methemmnine
`
`Methiodalsodiam
`
`Methions
`
`,
`
`Methylergonovinemaleate
`
`:
`N-Methylgiecamine
`a
`Metuzamide ©
`
`Monocthanolamine
`
`"
`
`Morphi
`i
`lorphinehydrochloride
`Morphinenitrate.
`
`Morphinesulfate
`
`-
`
`i
`Necarsphenamine =
`Neomycinsulfate
`
`i
`
`:
`
`Nicotinamide.
`-
`Nicotions acie'.
`MISC-52
`
`«nie
`
`acid
`
`o a t e O32
`O 1 6
`O
`016
`84014
`008
`a o e
`O16
`O18
`aor
`Q o
`O14
`O13)
`007
`O a r
`028
`0 2
`0087? GIG
`032
`03%
`OIF
` O09F
`022
`«4023.
`006r
`012
`0.24
`024
`006°
`OIF
`0.32
`028
`0 0 r
`01°
`0.10
`0.10,
`002°
`007m
`020
`0.20
`O I
`0.0577
`0.04.
`0.04
`oar
`ool?
`0.53
`0.53
`0.15
`O16
`ame
`0.22
`a o r
`ONG
`0.04
`0.42
`a n e
`
`=§=?0:07°
`0.40
`o2r
`0.12
`aoe
`0.26
`Ore
`0.25
`One
`
`:
`
`-
`
`.
`
`.
`
`'
`
`-
`
`7
`"
`
`O30.
`17
`e
`
`;
`
`?
`?
`S
`a 4
`?
`O28
`_
`0 2 .
`052°
`0 1 8 - 8
`O17)
`a a
`OSI!
`(052
`«Ol = 0 9
`_
`«O12
`( O I
`«OIF
`68275
`013
`O14
`O15
`O2F
`038
`a e
`O12
`0.10
`O12
`I
`f
`03%
`O20F
`024
`?
`026
`O42
`?
`O27
`?
`028
`030
`O47
`?
`03°
`?
`024
`0.24
`?
`027
`O4P
`024
`024
`?~
`?
`027°
`O4P
`?
`?
`0.25
`O22
`_
`_
`?
`_
`?
`~
`_
`?
`8 93
`O18
`O18
`021 == 937°
`ose
`_
`0.03
`oor
`oop
`?
`?
`.
`o k t
`
`?
`
`Oa
`=
`
`898,
`
`_
`
`_
`
`(038,
`
`2 8
`
`0 ,
`
`49%
`t a s
`
`B38
`0.10
`a r
`023
`026
`_
`
`_
`U5
`O15
`o i e
`aor
`0.16
`0.19
`O h
`o i e
`a i e
`014-6012 0 On
`Oly
`0.
`=
`0.
`o g |
`021
`«69377
`=
`
`MYLAN INST. EXHIBIT 1127 PAGE 8
`
`MYLAN INST. EXHIBIT 1127 PAGE 8
`
`
`
`N x
`
`IsotonicSolutions (Continued)
`
`Chemical
`hydrochloride
`Papaverine hy!
`
`ine
`
`Paraldehyde
`
`a
`
`n
`
`Phenobarbital sodium
`
`Phenol
`
`25
`
`05%
`0.10
`0.028
`0.25-
`0.071
`0.24
`0.06
`" 0 , 3 8 :
`3 8 :
`0.10%
`
`.
`
`.
`
`.
`
`.
`
`18
`
`.
`
`Concentration of Solution, NaCl Equivalents
`At Isosmotic
`3% =
`2%
`Concentration
`1%
`_
`0.10
`0.10
`_
`0.06 = 9 . 1
`9.25
`0.25
`0.25
`0.14 = 0,28 ~? 4 3
`023
`024
`023
`0.17
`026
`939°
`0.35
`0.33
`.
`O19
`O39
`
`.
`
`_
`
`5%
`_
`_
`?
`_?
`?
`?
`?~
`?
`13
`0.36"
`
`_
`0.25
`0.52
`023
`0.52°
`0.32
`052
`0.11
`?s«0.52°
`
`-
`
`3.
`Sees
`3.95%
`3.95%
`2.8%
`28%
`823%
`8.23%
`
`Phenylethyl alcohol
`
`oa
`
`~
`
`3
`
`_~
`
`_?
`
`Polyethylene glycol 300
`
`Polyethylene glycol 400 -
`
`Polyethlene glycol 1500
`
`Polyethylene glycol 1540
`
`:
`
`os
`
`Polyethylene glycol 4000
`
`Polymyxin B sulfate
`
`.
`
`Polysorbate 80°
`
`3
`
`of
`c
`
`ou
`
`Polyvinyl
`Suny! alcohol (99% hydrolyzed)
`.
`
`Potassj
`Massium acetate
`
`8
`
`:
`
`,
`
`.
`
`-
`
`-
`
`6.73%
`6.73%
`8.50%
`8.50%
`10.00%
`10.00%
`
`153%
`153%
`
`0.052
`2 5 .
`0.070
`0.12
`0.034
`0,08:
`0.022°
`0.06
`0.015?
`0.02-
`0.005°
`0.02
`0.004
`0.10
`0.033?
`0.02:
`0.00°
`.
`? 9 . 0 2
`0.004
`0,59.
`O 7 7
`
`t
`
`.
`
`0.50
`0.140°
`
`O n e
`0.34
`
`0.58
`.
`0.1632
`
`O342
`
`O e
`
`;
`
`o n 3°
`
`0 45°
`
`076 0
`
`Potassi
`tassium chlorate
`
`|
`
`Potace;
`s i u m chloride
`
`Potassium
`
`iad:
`
`Potassium
`Im
`
`ni
`
`nutrate
`
`.
`
`Potassi
`*tassium permanganate
`Potag;
`2ssium phosphate,anhydrous
`:
`Potase:
`"sium Phosphate, monobasic
`
`Potace:
`lassiumsorbate
`
`.
`
`Potage:
`
`?Ssium sulfate
`
`.
`.
`017°
`0.24"
`0.09%
`?
`0.25
`0.25
`_
`?
`?
`0.14.
`0.25°
`0.13
`0.13
`0.12
`0.12
`0.12
`021°
`0.52
`037°
`014
`0.08:
`0.09
`0.09
`0.09
`0.11
`0.08
`0 . 2 7 2 5 2 ?
`0 . 0 = 0.1?
`0.04
`0.06.
`0.07
`0.07
`0.09
`0.07
`0 . 1 0 . 2 1 "
`0.03"
`(0.07
`0.52?
`0.3
`?_
`0.03
`0.02
`0.02
`0.02
`0.04
`0.09
`_
`001°
`=
`0.02.
`0.02
`0.02
`0.02
`0.03 ??(0.08?
`?
`0.00
`0.02?
`_
`0.07
`0.06
`0.09
`0.04
`0.04" = 0.07°
`?
`«0.09
`~?-.13°
`0.02
`0.02
`0.02
`?
`0.02.
`005°
`0.03
`?
`0.01?
`0.022
`?
`0,02
`0.03
`0.02
`0.02
`003
`0.00
`0.02
`_?
`O077
`0.59
`?
`?
`? -
`059 -
`934
`_
`?
`052
`0.49
`?
`?
`048
`?
`?
`0.52°
`?-0,27°
`?
`?
`0.76:;
`O
`?
`
`?
`?
`_
`O
`0.34
`
`owe
`
`0.34
`
`-
`
`1.88%
`1.88%
`1.19%
`
`2.59%
`
`162%
`162%
`
`211%
`211%
`218%
`2.18%
`2.23%
`2.23%
`211%
`2.11%
`
`MISC-53
`
`?
`
`0.34
`
`vor
`?
`?
`
`_?
`
`%?
`?
`?
`?
`?_
`
`_?
`
`?
`
`?_
`
`056,
`°
`052
`?
`?_
`
`0.43,
`052
`041°
`= 0.52
`0.40
`0.52
`043
`0.52
`
`0.56
`032
`.
`
`3
`
`o 3 .
`
`?
`?
`?
`?
`?
`39
`_
`O4e
`?
`0.43
`04% = ?
`036°
`44 ~?s 0,42
`_?
`?
`0. 25°
`?-0,48°
`Al.
`0 27°
`044
`0.25°
`
`0.40
`0.46°
`048
`0.49°
`
`_?
`_
`?
`?
`
`MYLAN INST. EXHIBIT 1127 PAGE 9
`
`MYLAN INST. EXHIBIT 1127 PAGE 9
`
`
`
`? ? e
`
`S S
`
`4 a a 7 ? ?
`
`Potassium thiocyanate
`n e o n
`
`i
`
`Povidone
`Propylene
`
`pyiene
`
`glycol
`
`061
`018°
`0.01
`o00r
`0.44
`0.12e@
`
`0.41
`Ouse
`0.28
`0.08?
`0.08
`0.022
`
`,
`i t e
`0.08
`0.022
`0.33
`0.09"
`0.17.
`0.047°
`0.12.
`0.033°
`0.47
`0.136
`0.08
`0.2260°
`0.14
`0.03"
`0.26
`0.07#
`0.34.
`0.097
`0.40.
`
`°
`
`0.68.
`0.197?
`0.45
`O12e
`0.40
`0.109
`0.50 »
`0142
`0.20
`0.055°
`;
`64
`OBE
`048°
`0.1379
`
`059
`03%
`0.01
`007
`0.43
`0 2 °
`0.36
`020°
`028
`0160
`
`?
`?
`0.01
`o o r
`0.43
`O47
`0.32
`030
`4028
`031°
`0.08
`007%
`
`0.07
`0.08
`0.08
`0.08
`
`0.08
`0 0
`0.07
`0 0 f
`0.08
`8008
`(kk
`0.38
`017
`0.17.
`0.17
`«(0.0% = 0.18
`0.08
`0.06
`0.04°
`0.06°
`0.46.
`0.45
`0.26°
`OS®
`?
`0.77
`_
`0.44"
`013.
`0.13
`0.18
`0.07°
`0.25
`0.25
`860.14
`860.277
`0.30
`035°
`0.40
`
`0.32
`0.18°
`0.40
`
`_
`
`0.65
`0.38
`0.43
`0 2 r
`0.36
`020
`946.
`028
`0.19
`O1P
`0.61
`937
`0.37
`=042?
`O2g = 4 ?
`
`0.41
`0477
`
`°
`
`0.3
`
`Ose
`0.43
`:
`04ap
`0.18
`0.20
`?
`
`?_
` ?
`0.10
`0.0
`?
`?
`0.29
`0 5
`«40027,
`047
`0.08
`015°
`0.07
`O12
`0.08
`0 1 °
`?
`a
`0.17
`0.28"
`0.05
`0.08°
`_
`?
`?
`?
`0.12
`020
`0.24
`0 4
`?
`?
`_
`
`??
`
`_
`_
`
`_
`
`_?.
`?
`
`0.01
`?
`?
`?
`_
`«2 =
`?
`_
`_
`0.07
`O1F
`0.08:
`021
`?
`?
`0.16.
`047°
`0.04 -
`0.18?
`?
`?
`?_
`?
`0.12
`033%
`?
`
`_?
`?_
`
`?
`
`?_
`
`=
`~
`
`=
`
`S o e
`
`0
`18°
`030
`_
`
`017)
`o a
`
`=
`
`059
`05s?
`?
`?
`0.43
`052
`
`_?
`
`027
`O52
`_?
`_?
`0.06
`O52
`
`?
`= 033
`0.52°
`0.16
`0.52"
`?
`?_
`045
`052°
`0.76
`0.52"
`0.12
`O52
`0.24
`52
`0.30
`0.52°
`0.40
`
`i n g
`152g
`
`210%
`
`33%
`33%
`
`149%
`149%
`
`274%
`2.74%
`
`5.51%
`S51%
`
`2.03%
`2.03%
`
`1.18%
`1.18%
`19%
`19%
`383%
`3
`299%
`299%
`
`225%
`
`0.65
`139 %
`B S
`139%
`4 1 - 2 2 %
`s e
`a h
`
`932,
`,
`O B
`
`O
`O52"
`
`,
`035,
`
`a t
`
`21%
`
`%
`5.29
`5.29%
`
`134
`%
`e t
`
`|
`
`|
`
`aly
`idoxine hydrochloride
`"
`
`~
`
`,
`
`Pye
`Resorcinol
`
`Rose
`
`Riboflavin phosphate, sodium
`o e
`bengal
`m e n s
`Rose bengal B
`.
`Silver nitrate
`a
`Silver protein, mild
`
`,
`
`Silver protein, strong
`
`Sodium acetate
`
`?
`
`:
`
`Sodium acetate, anhydrous
`*
`Sodium antimony] tartrate
`
`Sodium arsenate, dibasic
`
`,
`
`.
`oa
`
`oo
`
`~
`
`,
`
`.
`
`7
`
`.
`
`Sodium ascorbate
`
`Sodium benzoate
`
`t
`
`Sodium bicarbonate
`fiz
`me
`Sodium biphosphate monohydrate
`
`:
`
`7
`
`:
`
`Sodium biphosphate dihydrate
`
`Sodium biphosphate, anhydrous
`e e
`2
`Sodium bismuth thioglycolate
`-
`Sodium bisulfite.
`u
`:
`Sodium borate::
`
`}
`
`MISC:54
`
`POS
`
`T
`
`I
`
`MYLAN INST. EXHIBIT 1127 PAGE 10
`
`MYLAN INST. EXHIBIT 1127 PAGE 10
`
`
`
`.
`
`Chemical
`
`?
`TT
`bromide
`
`?ym
`
`sodium
`
`jum cacodylate
`
`-
`
`Sod
`
`?um carbonate, anhydrous
`Sodtu
`?um carbonate, monohydrated
`
`}
`
`Sod
`
`Sodium carboxymethy] cellulose
`
`odium chloride
`Sot
`
`0.5%
`0.58
`O16
`0.38
`010"
`0.74
`021°
`0.64
`0.18%
`
`Isotonic Solutions (Continued)
`Concentration of Solution, NaCl Equivalents
`At Isosmotic
`Concentration
` e ? : C « C
`1.6%.
`0.57
`S P
`1.6%
`3.3%-
`0.27 °°.
`052
`3.3%
`.068 .~ 1.32%
`052
`132%
`1.56%
`0.58
`156%
`052%
`?
`?
`1.00
`052
`+030
`052
`-. 0:13:
`0.52
`?
`?
`tens
`?
`4 0 3 8 ° .
`052 |
`0 5 2 .
`052
`_
`
`.
`
`0.9%
`09%
`3.02%
`3.02%
`6.85%
`6.85%
`
`5%
`?
`
`?
`
`?
` ?
`?
`?
`_
`?
`?
`?
`?
`?
`?
`?
`013
`(038°
`?
`?
`?
`?
`?
`?
`?
`_
`
`_?
`
`2%
`?
`
`3%
`?
`
`
`
`0.30
`033
`?_
`?
`?
`?
`?
`?
`_
`_
`030
`034
`014
`(0.16?
`
`0.28
`048
`?
`?
`?
`_
`?
`?
`_
`=
`0.30
`0 5
`014
`(0.23
`0.10
`0.11
`1 2 0 1
`?
`?_
`?
`_
`_
`?0.39
`04"
`
`?
`0.07
`008?
`_
`
`?
`
`_
`_
`0.05
`0 0
`
`_
`_
`
`Co
`
`Sodium citrate
`S
`Sodium colistimethate
`
`}
`
`Sodiumfolate
`
`mS
`a
`P
`Sodium hypophosphite .
`e e e
`
`Sodium iodide
`
`Sodium lactate
`
`|
`
`_.
`
`-
`
`E
`
`cE
`
`OF
`
`.
`
`-
`
`ae
`
`sulfat
`
`Sodium laury!
`ey
`Sodium metabisulfite
`sume
`
`a
`
`:
`
`.
`
`»
`
`° ¢°
`
`o y .
`
`ee
`
`1%
`0.58
`0 3
`0.32
`O18
`0.70
`0 4
`0.60 :
`032
`0.03
`0.03
`O00
`0.0077
`_
`1.00
`=
`0289
`032.
`031
`017°
`0.091
`015°
`016°
`0.08.
`0.045°
`012°
`014°
`0040 = «0.08
`0.68
`0.61
`019°
`03°
`0 4 1 © 039°
`OFT
`0.22.
`0 5 8 0 5 5 5
`O03
`0 1 6
`0.08:
`0.10
`029°
`00k.
`070°
`0.67
`9206
`038
`0745
`068:
`o o . O2Ie
`03%
`086
`0.84
`0.248 «= 0.4
`930.
`0.29.
`0 8
`=O?
`0.29:
` 0,30.:
`COR
`«O18
`044
`042
`024
`0.127°
`0.22
`0122
`053.
`03°
`0.61
`0 8 8
`010
`010
`«(«0.06?,-?s«i<?
`
`«0.28
`0 3 2 2 0 4 7 ?
`0.27
`0.28
`( 0 3 0 4 7 ?
`?
`041
`|
`?
`O47
`0.21
`0.21
`03°
`024
`?
`?
`?
`?
`?
`?
`0.09
`O
`?
`?
`
`41
`
`(0.21
`
`_?
`
`>
`
`0.24
`0.064
`056
`0 9
`0.62
`01777
`0.10:
`0.033?
`
`0.38
`0.106°
`
`0.36
`0.20°
`
`0.36
`0.41°
`
`Sodium nitrat
`mate
`Sodium nitrite
`
`a ,
`-
`
`Sodium nitroferricvani
`ttroferricyanide
`wut
`Sodium ph
`Phosphate
`
`vo
`
`s
`
`s
`
`.
`
`-
`
`.
`
`:
`
`6
`
`di
`
`Sodium phosphate
`h
`dihacic
`= Phosphate, dibasic dihydrate
`Sodium
`
`"alum
`
`dihaci
`ahydrate
`phosphate,
`Phate, dibasic dodecahy
`
`Sodium
`;
`
`dium
`
`Sodium
`
`phosphate, exsi
`Puosphate, exsiceated =
`:Propionat
`Pionate
`
`7
`
`Sodium
`
`«:
`UM rici
`tnoleate
`Soin;
`salicy]
`yiate
`
`volun
`
`a
`
`?
`
`_
`
`_?
`
`~?0.28
`
`237%
`237%
`172%
`172%
`_
`-_
`1.38%
`e 0 6 5
`?
`0522
`«138%
`066 i . 136%
`?
`186%
`C852
`083
`1.08%
`632
`1.08%
`027-5. 3.30%
`330%
`53?
`0.27: 1°
`3.33%
`g e
`S 3 3
`2.23%
`040°
`"os
`©=?-'2:23%
`0.20
`052°
`051
`052%
`
`ae
`
`~
`
`-
`
`ar
`
`-.
`
`.
`
`;
`
`4.45%
`445%
`+ 1.75%
`175%
`1.47%
`1.47%
`.
`
`0.61
`052
`_
`
`036:
`0.52°
`
`253%
`253%
`MISC-55
`
`?
`?
`me:
`
`?
`
`?
`?
`?
`?
`?
`?
`?
`?
`0.09
`S
`?
`
`_?
`
`MYLAN INST. EXHIBIT 1127 PAGE 11
`
`MYLAN INST. EXHIBIT 1127 PAGE 11
`
`
`
`Isotonic Solutions (Continued)
`Concentration of Solution, NaCl Equivalents
`eee!
`A
`t Isosmoti
`Concentration
`031)
`2:99
`052
`2.909,
`0.23
`3.95
`052
`392
`O 5 1 ) .
`1.78%
`082
`1.789,
`?_
`?
`§ 033,
`0.52
`0.30
`0.52°
`0.16
`0.52
`0.18
`0.52"
`?
`?
`?
`?
`?
`?
`?
`_
`0.10
`9.25%
`0.52°?«94.25%
`?
`?
`?
`
`5%
`?
`?
`?
`?
`_
`?
`
`?_
`
`?
`?
`?
`?
`?
`O16
`(0.48
`0.18
`0.52?
`0.16
`046
`0.06
`0177
`?
`?
`?
`_
`0.09
`0.260?
`
`9,
`O12"
`
`;
`poe
`?
`_?
`a
`_
`_
`
`2.72%
`2.72%
`
`2.98%
`2.98%
`
`5.48%
`5.48%
`
`-
`
`5.0%
`5.0%
`
`e s
`
`0.28,
`
`3 3 ,
`
`O21
`
`ONT
`
`-
`
`i
`
`?
`
`023,
`
`O20
`
`9%
`39%
`
`3.17%
`3.17%
`
`-2,61%
`Ferm
`
`4.24%
`4.24%
`
`1%
`1 %
`561%
`
`05%
`405%
`
`3.31%
`3.31%
`
`~
`
`_
`_
`
`~
`9 ,
`O16,
`
`=
`
`_
`
`_
`
`?_?
`
`?
`?
`?
`0.09
`0.1?
`005
`?-0.08°
`
`0.03
`O0r
`0.23
`0.40
`0.28
`Q49
`?
`~
`0.22
`90377
`_
`~
`016
`o27
`?
`?
`
`Oage
`
`9.27
`9.479
`
`Chemical
`
`Sodium succinate
`
`Sodium sulfate
`
`Sodium sulfate, anhydrous
`
`Sodium sulfite, exsiccated
`
`Sodium tartrate
`
`Sodium thiosulfate
`
`Sorbitol hemihydrate
`
`Streptomycin calcium chloride
`v
`Streptomycin hydrochloride
`
`.
`
`,
`
`Streptomycin sulfate
`
`Strychnine hydrochloride
`
`Strychnine nitrate
`
`Sucrose
`
`Sulfobromophthalein sodium
`°
`P
`
`?acid
`Tannic act
`
`acid
`
`-c
`
`Tartanicacl
`thylammonium bromide
`Tetraethy/amm
`
`lammonium chloride
`Tetraethylamn
`hydrochloride
`Thiamine y
`
`.
`
`amine
`
`.
`
`Thiocyanate sodium
`<-TEPA
`Thio-TE
`.
`Tribromoethanol
`
`;
`Triethanolamine
`
`.
`
`a
`
`_ monohydrate
`Trisodiumedetate
`¥
`MISC-56
`
`he
`vey
`es.
`
`2%
`3%
`1%
`_
`031
`0.32
`?
`0.18 = 0.368
`025
`0.26
`0.23
`0 4 °
`018
`028
`_
`_
`0.54:
`?
`0.30
`?
`_
`0.65
`?
`?
`037°
`?
`0.33 = 0.33
`?
`0.38
`0.19%
`?
`0.31
`0.31
`?
`0.18
`0.3%
`016
`016
`0.16.
`«0.09 ~=? 1 9 0 . 2 8 "
`0.20
`0.19
`0.19
`O I . = 0.21?
`0,32",
`0.17
`0.17
`0.16
`0.09
`0.19
`0.28
`0.07.
`0.07
`0.06
`0.03
`O10
`0.077
`0.14
`0.18.
`0.09 = 0.16
`?
`0.12
`0.06?
`
`_?
`
`_?
`
`0.5%
`0.32
`0.092
`0.28
`0077
`0.58
`0.16"
`0.72
`0.208
`0.33
`0.09%
`0.32
`0.0922
`0.16
`0.04
`0.20 -
`0.057°
`0.18
`0.05°
`0.08 .
`0.020
`0.20 -:
`0.060
`0.12
`0.03"
`0.08
`0.023?
`0.07:
`0.01"
`0.03:
`0.03.
`0 0 r
`0.009
`025
`0.26:
`0.07° = 0.14"
`0.36
`0.33
`018
`0.098
`0.36
`0.34
`010°
`OIF
`025
`0.26
`0.074
`013°
`0.17
`0 4 r
`016
`0.0%
`0.0
`0.03°
`
`0.08-
`0.04
`006:
`0.03?
`
`0.09
`0.09
`005
`0.06
`003
`0.03
`0.24
`?0.27°
`0.30
`034
`0,33
`03%
`023
`028
`_
`0.71
`?
`020°
`016
`0.16
`018
`0.04°
`0.05
`0.06
`0015
`0.05°
`0.20:
`0.22
`0.21
`0.058 ? 0 . 1 2 . 2 5
`029
`0.29
`0,28
`0.079
`015°
`031°
`
`MYLAN INST. EXHIBIT 1127 PAGE 12
`
`MYLAN INST. EXHIBIT 1127 PAGE 12
`
`
`
`I
`
`o
`
`? Chemical
`
`Isotonic Solutions (Continued)
`s
`Concentration o f Solution, NaCl Equivalents
`Isosmotic
`A t
`Concentration
`
`2% °° =
`
`3%
`
`5%
`
`0.5%
`
`1%
`
`thamine
`Trome
`
`an blue
`
`TP
`Tubocurarine chloride
`
`Urea
`
`ethan
`
`u
`
`Uridine
`
`Warfarin sodium
`
`Zinc chloride
`
`Zinc p-phenosulfonate,
`
`Zinc sulfanilate
`
`Zinc sulfate
`
`Zinc sulfate (dried) ?
`
`0.26
`0.07
`0.26
`007°
`014
`0.0422
`
`~
`
`.
`
`:
`
`i
`
`.
`
`|
`
`-
`
`,
`
`-
`
`|
`
`0.26
`015°
`0.26
`O18
`013
`0.07?
`0.53
`0.55
`.0.30°
`0.158°
`0.31
`0.31
`017°
`0.089
`O12?
`O12
`0.00
`0.035
`017
`O18
`0.09
`0.049
`066 «= (0.61
`?
` 0.190°
`?0.35°
`0 1 7 °
`018
`018
`0.17
`0.18
`0.29 ~?
`0.10 = 0.19?
`048°
`0.053?
`0 2 1 ° 0.20 © « 0 . 9 . 8
`9 2 2
`0.12). 022
`0.066?
`86032
`«(05RP
`Sti
`O B
`916)
`015°
`0.08
`0.045
`0.22?
`024
`0 2 3 - 0 2 2
`0 2 1
`0.136
`_
`0.3622
`0.072?
`0.252"
`References
`l. E.R. Hammarlund, K. Pedersen-Bjergaard, l Am. Pharm. Assoc., Sci. Ed. 47, 107(1958):
`a
`2. E.R. Hammarlundet al., J. Pharm. Sci. 54, 160 (1965).
`3. E.R. Hammarlund, G. L. Van Pevenage, ibid. 55, 1448 (1996).
`H W.E. Fassett et al., ibid. 58, 1540 (1969).
`Oo
`CERi
`e
`i d ot
`e e t ) ,
`1, i R. Gennare as. "Remingion?' s Pharmaceutical Sciences (Mack Publ. Co., Easton, PA., 17th ed., 1985) pp 1455-
`72,
`8 E.R. Hammarlund, J, Pharm. Sci. 78, 5199
`(1988).
`
`0.26
`0.26
`045°
`030°.
`_
`=
`?
`?
`010
`O11
`0 . 1 2 2 0 1 7 "
`_
`_
`?
`_
`?
`031
`035°
`_?
`Of2
`012°
`020°
`0.13?
`015°
`O16
`018
`0.20
`
`°
`
`2.
`
`?
`?
`?
`?
`0.09
`2 8 °
`?
`?
`?
`?
`0.12
`033°
`§ 0.15
`043
`_
`
`°
`
`3.41%
`3.41%
`
`1.73%
`1.73%
`2.93%
`2.93%
`8.18%
`818%
`6.10%
`6.10%
`
`0.26
`0522
`_
`=
`?
`?
`0.52
`052
`0.31
`0522
`0.11
`0.52?
`0.15 ~
`052°
`?
`?
`?
`?
`?
`
`s?(?i
`
`035°
`
`?
`
`052°
`i 2 0 4
`?si0522
`
`CC %
`7.65%
`5 2 %
`452%
`
`'
`
`oo
`
`~ ~
`
`MISC-57
`
`MYLAN INST. EXHIBIT 1127 PAGE 13
`
`MYLAN INST. EXHIBIT 1127 PAGE 13
`
`