`L-224,715-006F007
`
`Project Code : 0726
`
`
`K. HANSEN
`
`Prepared By:
`
`Empirical Fomula:C16H16F6NSO 408.329 H204P 96.987
`
`
`
`
`18-APR-20%
`Molecular Weight: 505 . 317
`
`
`
`.(ZR) —4-OXO-4- [ 3- (TRIFLUOROMETHYL) -5, 6-
`hemical name:
`
`IIIHYDROll, 2 , 4 ] TRIAZOLOI 4 , 3-A] PYRAZIN-7 (8H) -YL) -1- (2, 4 , 5-
`RI FLUOROPHENYL) BUTAN-Z-AMINE PHOSPHORIC ACID SALT
`
`
`
`Reference:
`588 G
`Amount Made:
`
`25-MAR—2002
`Date Of Manufacture:
`
`
`
`Sample ID(s) :‘
`200004568
`
`Structure:
`
`
`Date(s) Tested: 25-MAR-2002
`
`
`Nature Of Change:
`FIRST DELIVERY
`
`Milled:
`N
`Process Change:
`N
`
`
`Restricted ReIease By:
`J. ARMSTRONG AND R. nurse
`
` Send To: Bob Hartell urn-no 5209 PM Form
`
`
`
`
`
`
`10 g (stability) J. box-wart RYale-CZOB (already sent)
`
`
`72471—017
`
`Reserve Sample
`RY28
`1 gram
`
`
`‘/7-/?A€-A’
`-
`
`
`
`
`
`REFRIGERATED aming: PB-ECL CODE P3 ' storage Conditions:
`
`
`
`wen:
`powm-zn
`
`Reference Std-
`
`ggfifgln‘glsggfi?
`AGGLOMERAHON
`
`7-77 8% N9
`
`L—224715—ooaroos
`man 72471-011
`PPCL“ 0213276
`specrrzc ROTATION (some)
`DI HATER
`Solvent
`Concentration
`1.0 (uh/)3
`Wavelength
`355 m
`Specific Rotation
`44.4 degrees‘
`nsc CHARACTERIZATION
`1- onset 1
`216.9 degrees _C
`1'
`l
`, max
`219.7 degrees -c
`Delta H 1
`1131 J/g
`'l'G
`"JD. w,“
`Weight Loss 1
`224,2 degrees —c
`Final Temp
`envy METALS a! ICP/MS
`“5K2“, and 59A
`<10_ ppm
`regulated elements
`WC! AS-IS
`
` 500m; FREEZER -/y.
`MICROSCOPIC EXAM
`IDENTITY 3! ”IR
`
`.ance
`CLEAN
`Observations ’
`ANISOTROPIC,
`Conforms
`YES
`
`
`
`C
`
`
`F011“
`
`
`
`
`
`SURFACE AREA
`X-RAY
`surface “ea
`CRYSTALLINE
`observations
`
`
`PARTICLE SIZE
`151- mp DELIVERY
`Reference Std.
`
`
`Technique
`IMPURI'IY PROFILE
`
`
`
`
`
`D“"“’““°“ ”9°
`an 0.95
`0.13 a
`
`
`”m“ m"
`m 0.97
`0.14 a
`
`
`gigtrfiution
`Total impurities
`0.32 g
`(I of quantifiable
`1
`
`
`95% <
`impurities <0.10%
`I < size
`No other impurity
`0.05 I
`
`
`size
`->
`
`
`a
`e
`-
`_
`BULK DENSITY
`:nI'fRfTION - PERCRLORIC ACID
`Q
`Loose density
`Resuzt
`1. 224715 0065'
`
`Tapped density
`1°°-° ("MB
`TIWION - SODIUM HYDROXIDE COIDR (SOLID)
`
`Analyte .
`PHOSPHATE
`Solvent
`R
`1:
`
`esu
`19.9 ("I")?
`Concentration
`'SORBANCE - 151'
`1
`h
`
`ENGTH
`"an am
`A! x 1000
`
`NEPHELOS
`Wavelength 1
`
`wave en
`
`Concentration
`REJJ 1“
`F1 cg
`Result
`KARL
`S BER (
`
`PB
`<o.1 HIV!
`Water
`
`Solvent
`:iIDUAL SOLVENTS
`
`Concentration
`("/"H
`"'0'
`sample pg
`RESIDUE 0N IGNITION BY ICP
`
`DISC
`Wt! of residue
`<0.05 (u/H)!
`_
`.
`
`Solvent
`CHIRAL PUP-IT!
`(sample)
`Net wt.
`99.99 3
`L 224,715
`
`to Std
`1,400,224
`N.D. 8
`visual Comparison
`
`
`
`
` ‘ ‘Del. Sheet By:
`SCOTT THOMAS
`18-APR-2002
`
`
`
`I
`,
`Reviewed By
`v
`.‘A‘h‘
`-
`A
`93.4 ‘
`-‘
`
`
`Transferred By:
`Run ID:
`103263798
`
`
`
`
`”Sm“
`C: Egan RYElB-BZOS, Eiserle RYSlB-C221, Thomas RYBlB-CZOB, Wyvratt RY818~3201,
`Hansen RY800-8269, Armstrong RYBOO-D371, Palucki RY800—B363, Kumke RY819—405
`R Geomaanflal
`
`
`D DELIVERY SHEET: CHEMICAL FOR CLINICAL OR PRECLINICAL TESTING
`L00: K
`PULLED;,0mt WEIGHEDAZ. SENT:W4”;
`Merck Exhibit2135 a?”
`Mylan v. Merck, |PR2020—00040
`
`
`
`.
`
`mcno TRAC
`VOLUME
`63» um
`38. um
`143. um
`17_ 5
`25 um
`
`0.46 g/ml.
`0.60 gm.
`
`DI WATER
`
`1.0 (W/VH
`440 m
`5,
`
`1.0 (HIV)!
`1.1 ntu
`
`DI WATER
`1,0 (w/VH
`4 7 pH
`-
`DI WATER
`2_2 grams
`< 5n: 1
`
`.
`
`Puma}!
`M
`Rationale
`
`WT!
`Purity
`Rationale
`
`99.6 E
`L-2247l5 PH seam:
`SALT
`o
`_
`_
`”00 RF GC] x
`‘
`
`CHIRALH
`99 7 i
`BASED on 11ch
`1“ g
`
`-
`
`DEIONIZED HATER
`267 o
`'
`
`
`
`
`
`‘ Dry basis
`
`
`
`
`Merck Exhibit 2135
`Mylan v. Merck, IPR2020-00040
`
`