MK-0431 Tablet
`3 Quality
`3.2.P.5.4 Batch Analyses
`
`
`Table of Contents
`
`List of Tables
`5.4 Batch Analyses
`5.4.1 Summary of Method Changes for the Dose Uniformity Methods
`5.4.2 Summary of Dissolution/Disintegration Method Changes
`5.4.3 Summary of Composite Assay/Degradate/Identity Method Changes
`
`
`1
`
`
`
`PAGE
`2
`3
`33
`34
`36
`
`3.2.P.5.4 Batch Analyses
`
`
`
`14-Nov-2005
`Final
`
`Merck Exhibit 2108, Page 1
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
`3 Quality
`3.2.P.5.4 Batch Analyses
`
`
`Table of Contents
`
`List of Tables
`5.4 Batch Analyses
`5.4.1 Summary of Method Changes for the Dose Uniformity Methods
`5.4.2 Summary of Dissolution/Disintegration Method Changes
`5.4.3 Summary of Composite Assay/Degradate/Identity Method Changes
`
`
`1
`
`
`
`PAGE
`2
`3
`33
`34
`36
`
`3.2.P.5.4 Batch Analyses
`
`
`
`14-Nov-2005
`Final
`
`Merck Exhibit 2108, Page 1
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
`
`MK-0431 Tablet
`3 Quality
`3.2.P.5.4 Batch Analyses
`
`
`List of Tables
`
`Table 3.2.P.5.4-0431-tablet: 1 Batch Analysis Results for MK-0431 Capsule
`
`Table 3.2.P.5.4-0431-tablet: 2 Batch Analysis Results for MK-0431 Injection
`
`Table 3.2.P.5.4-0431-tablet: 3 Batch Analysis Results for MK-0431 Tablet
`(Anhydrous Form Drug Substance)
`
`Table 3.2.P.5.4-0431-tablet: 4 Batch Analysis Results for MK-0431 Tablet
`(Monohydrate Form Drug Substance)
`
`Table 3.2.P.5.4-0431-tablet: 5 Summary of Dose Uniformity Methods
`
`Table 3.2.P.5.4-0431-tablet: 6 Summary of Dissolution Methods
`
`Table 3.2.P.5.4-0431-tablet: 7 Summary of Composite Assay Methods
`
`
`
`2
`
`
`
`PAGE
`4
`
`8
`
`9
`
`22
`
`33
`
`35
`
`37
`
`3.2.P.5.4 Batch Analyses
`
`
`
`14-Nov-2005
`Final
`
`Merck Exhibit 2108, Page 2
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
`
`MK-0431 Tablet
`3 Quality
`3.2.P.5.4 Batch Analyses
`
`
`3
`
`
`
`5.4 Batch Analyses
`Batch analysis data for lots of MK-0431 Capsules used in clinical and stability studies are
`provided in [Table 3.2.P.5.4-0431-tablet: 1]. Batch analysis data for one lot of MK-0431
`Injection are provided in [Table 3.2.P.5.4-0431-tablet: 2]. Batch analysis data for lots of
`MK-0431 Tablets used in clinical and stability studies are provided in [Table 3.2.P.5.4-
`0431-tablet: 3] for the anhydrous form drug substance. Batch analysis data for lots of
`MK-0431 Tablets used in clinical studies, stability studies, and at commercial scale are
`provided in [Table 3.2.P.5.4-0431-tablet: 4] for the monohydrate drug substance. In
`addition to batch analysis data, the tables provide information relating to the batch size,
`site of manufacture, date of manufacture, drug substance batch number(s) and type of
`study in which the drug product was used. [Table 3.2.P.5.4-0431-tablet: 1], [Table
`3.2.P.5.4-0431-tablet: 3] and [Table 3.2.P.5.4-0431-tablet: 4] also provide information
`related to the analytical procedure version used for testing of each batch. Please refer to
`[Sec. 3.2.P.5.4.1-0431-tablet] through [Sec. 3.2.P.5.4.3-0431-tablet] for details on each
`version used. Release testing of all batches was conducted at Merck Research
`Laboratories located in West Point, PA, except for batch numbers 1050570, 1050581, and
`1050582, where release testing was conducted at Pavia, Italy. At batch release, all lots
`passed the acceptance criteria at the time.
`
`
`3.2.P.5.4 Batch Analyses
`
`
`
`14-Nov-2005
`Final
`
`Merck Exhibit 2108, Page 3
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
`
`MK-0431 Tablet
`3 Quality
`3.2.P.5.4 Batch Analyses
`
`
`Batch No.
`
`Potency
`Theoretical Batch Size (Capsules)
`Manufacturing Site
`
`Table 3.2.P.5.4-0431-tablet: 1
`
`Batch Analysis Results for MK-0431 Capsule
`0431DFC001A001
`0431DFC001B001
`0.5 mg
`2.5 mg
`4,100
`16,300
`Quintiles, Ltd.
`Quintiles, Ltd.
`Riccarton, UK
`Riccarton, UK
`20MAY2002
`07JUN2002
`
`Manufacturing Date
`
`Drug Substance Batch No.
`
`Studies Used In
`Analytical Procedure (Method #)
`Appearance
`Composite Assay (% label claim)
`(HPLC, W0431_001A)
`Identity
`Content Uniformity (HPLC,
`W0431_003U)
`Mean (% label claim)
`RSD (%)
`Range (%)
`Degradates
`Any single unspecified
`Total Degradates (%)
`Dissolution (W0431_005D)
`(Mean; Range)
`10 min (%)
`15 min (%)
`30 min (%)
`60 min (%)
`† White, opaque hard capsule
`
`L-000224,715-
`006F007
`Clinical, Stability
`
`Conforms†
`95.2
`
`Conforms
`
`
`96.5
`2.3
`91.6-101.7
`
`None >0.1%
`0.0
`
`
`94 (88-101)
`97 (94-103)
`99 (96-103)
`99 (97-104)
`
`L-000224,715-
`006F007
`Clinical
`
`Conforms†
`99.7
`
`Conforms
`
`
`98.4
`2.1
`94.1-100.9
`
`None >0.1%
`0.0
`
`
`100 (98-103)
`101 (100-103)
`102 (100-104)
`102 (100-104)
`
`4
`
`
`
`0431DFC001E001
`5 mg
`3,203
`Quintiles, Ltd.
`Riccarton, UK
`12JUL2002 /
`18JUL2002
`L-000224,715-
`006F017
`Clinical
`
`Conforms†
`100.8
`
`Conforms
`
`
`97.6
`1.8
`94.6-99.5
`
`None >0.1%
`0.0
`
`
`100 (98-103)
`102 (99-104)
`103 (101-105)
`103 (101-105)
`
`3.2.P.5.4 Batch Analyses
`
`
`
`14-Nov-2005
`Final
`
`Merck Exhibit 2108, Page 4
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
`
`MK-0431 Tablet
`3 Quality
`3.2.P.5.4 Batch Analyses
`
`
`Batch No.
`
`Potency
`Theoretical Batch Size (Capsules)
`Manufacturing Site
`
`Manufacturing Date
`
`Drug Substance Batch No.
`
`Studies Used In
`Analytical Procedure (Method #)
`Appearance
`Composite Assay (% label claim)
`(HPLC, W0431_001A)
`Identity
`Content Uniformity (HPLC,
`W0431_003U)
`Mean (% label claim)
`RSD (%)
`Range (%)
`Degradates
`Any single unspecified
`Total Degradates (%)
`Dissolution (W0431_005D)
`(Mean; Range)
`10 min (%)
`15 min (%)
`30 min (%)
`60 min (%)
`† White, opaque hard capsule
`
`Table 3.2.P.5.4-0431-tablet: 1 (Cont.)
`
`Batch Analysis Results for MK-0431 Capsule
`0431DFC001F001
`0431DFC001G001
`10 mg
`20 mg
`1,800
`2,493
`Quintiles, Ltd.
`Quintiles, Ltd.
`Riccarton, UK
`Riccarton, UK
`21JUL2002 /
`24JUL2002 /
`22JUL2002
`26JUL2002
`L-000224,715-
`L-000224,715-
`006F017
`006F017
`Clinical
`Clinical
`
`
`Conforms†
`Conforms†
`101.5
`100.1
`
`5
`
`
`
`0431DFC001C001
`25 mg
`1,000
`Quintiles, Ltd.
`Riccarton, UK
`06JUN2002
`
`L-000224,715-
`006F007
`Clinical
`
`Conforms†
`97.5
`
`Conforms
`
`
`98.1
`1.7
`94.6-100.6
`
`None >0.1%
`0.0
`
`
`95 (89-102)
`99 (96-102)
`100 (96-103)
`100 (96-103)
`
`Conforms
`
`
`102.1
`1.7
`99.4-104.6
`
`None >0.1%
`0.0
`
`
`98 (90-102)
`101 (95-103)
`102 (99-103)
`102 (98-104)
`
`Conforms
`
`
`100.0
`1.5
`98.7-104.0
`
`None >0.1%
`0.0
`
`
`99 (95-100)
`101 (100-102)
`101 (100-103)
`101 (100-103)
`
`3.2.P.5.4 Batch Analyses
`
`
`
`14-Nov-2005
`Final
`
`Merck Exhibit 2108, Page 5
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
`
`MK-0431 Tablet
`3 Quality
`3.2.P.5.4 Batch Analyses
`
`
`6
`
`
`
`Potency
`Theoretical Batch Size (Capsules)
`Manufacturing Site
`
`Table 3.2.P.5.4-0431-tablet: 1 (Cont.)
`
`Batch Analysis Results for MK-0431 Capsule
`Batch No.
`0431DFC001H001
`50 mg
`1,001
`Quintiles, Ltd.
`Riccarton, UK
`02AUG2002
`L-000224,715-006F017
`Clinical
`
`Conforms†
`101.0
`
`Manufacturing Date
`Drug Substance Batch No.
`Studies Used In
`Analytical Procedure (Method #)
`Appearance
`Composite Assay (% label claim) (HPLC,
`W0431_001A)
`Identity
`Content Uniformity (HPLC, W0431_003U)
`Mean (% label claim)
`RSD (%)
`Range (%)
`Degradates
`Any single unspecified
`Total Degradates (%)
`Dissolution (W0431_005D) (Mean; Range)
`10 min (%)
`15 min (%)
`30 min (%)
`60 min (%)
`† White, opaque hard capsule
`
`
`
`3.2.P.5.4 Batch Analyses
`
`
`
`Conforms
`
`100.3
`2.2
`97.2-103.2
`
`None > 0.1%
`0.0
`
`95 (84-100)
`101 (101-102)
`101 (101-102)
`102 (101-103)
`
`14-Nov-2005
`Final
`
`Merck Exhibit 2108, Page 6
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
`
`MK-0431 Tablet
`3 Quality
`3.2.P.5.4 Batch Analyses
`
`
`7
`
`
`
`Potency
`Theoretical Batch Size (Capsules)
`Manufacturing Site
`
`Table 3.2.P.5.4-0431-tablet: 1 (Cont.)
`
`Batch Analysis Results for MK-0431 Capsule
`Batch No.
`0431DFC002D001
`0431DFC001D001
`100 mg
`100 mg
`6,152
`1,800
`Quintiles, Ltd.
`Quintiles, Ltd.
`Riccarton, UK
`Riccarton, UK
`31JUL2002 /
`23MAY2002
`05AUG2002
`L-000224,715-006F017 L-000224,715-006F007
`Clinical
`Clinical, Stability
`
`
`Conforms†
`Conforms†
`100.9
`97.4
`
`Manufacturing Date
`
`Drug Substance Batch No.
`Studies Used In
`Analytical Procedure (Method #)
`Appearance
`Composite Assay (% label claim)
`(HPLC, W0431_001A)
`Identity
`Content Uniformity (Weight
`Variation, WGM053)
`Mean (% label claim)
`RSD (%)
`Range (%)
`Degradates
`Any single unspecified
`Total Degradates (%)
`Dissolution (W0431_005D)
`(Mean; Range)
`10 min (%)
`15 min (%)
`30 min (%)
`60 min (%)
`† White, opaque hard capsule
`
`Conforms
`
`
`100.9
`0.9
`99.5-102.6
`
`None > 0.1%
`0.0
`
`
`83 (49-100)
`102 (97-108)
`101 (101-102)
`102 (101-103)
`
`Conforms
`
`
`97.4
`2.0
`95.0–102.1
`
`None > 0.1%
`0.0
`
`
`94 (78-99)
`96 (84-100)
`98 (95-100)
`99 (98-100)
`
`
`
`3.2.P.5.4 Batch Analyses
`
`
`
`14-Nov-2005
`Final
`
`Merck Exhibit 2108, Page 7
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
`
`MK-0431 Tablet
`3 Quality
`3.2.P.5.4 Batch Analyses
`
`
`8
`
`
`
`Table 3.2.P.5.4-0431-tablet: 2
`
`Batch Analysis Results for MK-0431 Injection
`Batch No.
`0431HSS004A001
`10 mg/mL
`727
`West Point, PA
`04MAY2004
`L-000224,715-006F029
`Clinical
`
`Conforms†
`98.2
`Conforms
`
`None >0.2%
`0.0
`4.6
`Conforms
`Conforms
`
`47
`22
`11.1
`
`Potency
`Theoretical Batch Size (Liters)
`Manufacturing Site
`Manufacturing Date
`Drug Substance Batch No.
`Studies Used In
`Analytical Procedure
`Appearance
`Composite Assay (% label claim) (HPLC)
`Identity
`Degradates
`Any single unspecified
`Total Degradates (%)
`pH
`LAL
`Sterility
`Particulate Matter (particles/vial)
`Container ≥ 10 µm
`Container ≥ 25 µm
`Fill Volume (mL)
`† Clear, colorless solution
`
`
`
`3.2.P.5.4 Batch Analyses
`
`
`
`14-Nov-2005
`Final
`
`Merck Exhibit 2108, Page 8
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
`
`MK-0431 Tablet
`3 Quality
`3.2.P.5.4 Batch Analyses
`
`
`9
`
`
`
`Potency
`Theoretical Batch Size (Tablets)
`Manufacturing Site
`Manufacturing Date
`Drug Substance Batch No.
`
`Table 3.2.P.5.4-0431-tablet: 3
`
`Batch Analysis Results for MK-0431 Tablet (Anhydrous Form Drug Substance)
`Batch No.
`0431FCT002E001
`0431FCT002E002
`0431FCT003E001
`5 mg
`5 mg
`5 mg
`35,000
`35,000
`125,000
`West Point, PA
`West Point, PA
`West Point, PA
`22APR2003
`22APR2003
`14JUL2003
`L-000224,715-
`L-000224,715-
`L-000224,715-
`006F023
`006F023
`006F024
`Clinical
`Clinical
`Clinical
`
`
`
`Conforms†
`Conforms†
`Conforms†
`97.8
`96.4
`98.3
`
`Conforms
`
`
`97.8
`0.6
`96.3-98.4
`
`None >0.1%
`0.0
`
`
`98 (97-99)
`99 (98-100)
`99 (98-100)
`99 (98-100)
`99 (98-100)
`
`Conforms
`
`
`97.7
`2.1
`93.3-99.7
`
`None >0.1%
`0.0
`
`
`101 (98-103)
`102 (99-103)
`102 (99-104)
`102 (99-104)
`102 (99-104)
`
`Studies Used In
`Analytical Procedure (Method #)
`Appearance
`Composite Assay (% label claim)
`(HPLC, W0431_009A)
`Identity
`Content Uniformity (HPLC,
`W0431_008U)
`Mean (% label claim)
`RSD (%)
`Range (%)
`Degradates
`Any single unspecified
`Total Degradates (%)
`Dissolution (W0431_011D)
`(Mean; Range)
`100 (100-101)
`5 min (%)
`101 (100-101)
`10 min (%)
`101 (100-101)
`15 min (%)
`101 (100-101)
`30 min (%)
`101 (100-101)
`60 min (%)
`† White, round, biconvex, film-coated tablet
`
`Conforms
`
`
`98.1
`0.6
`97.1-98.9
`
`None >0.1%
`0.0
`
`
`
`
`3.2.P.5.4 Batch Analyses
`
`
`
`14-Nov-2005
`Final
`
`Merck Exhibit 2108, Page 9
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
`
`MK-0431 Tablet
`3 Quality
`3.2.P.5.4 Batch Analyses
`
`
`10
`
`
`
`Potency
`Theoretical Batch Size (Tablets)
`Manufacturing Site
`Manufacturing Date
`Drug Substance Batch No.
`
`Table 3.2.P.5.4-0431-tablet: 3 (Cont.)
`
`Batch Analysis Results for MK-0431 Tablet (Anhydrous Form Drug Substance)
`Batch No.
`0431FCT003E002
`0431FCT003E003
`0431FCT003E004
`5 mg
`5 mg
`5 mg
`125,000
`125,000
`125,000
`West Point, PA
`West Point, PA
`West Point, PA
`25AUG2003
`29SEP2003
`06JAN2004
`L-000224,715-
`L-000224,715-
`L-000224,715-
`006F029
`006F024
`006F029
`Clinical
`Clinical
`Clinical
`
`
`
`Conforms†
`Conforms†
`Conforms†
`98.0
`98.2
`97.0
`
`Studies Used In
`Analytical Procedure (Method #)
`Appearance
`Composite Assay (% label claim)
`(HPLC, W0431_009A)
`Identity
`Content Uniformity (HPLC,
`W0431_008U)
`Mean (% label claim)
`RSD (%)
`Range (%)
`Degradates
`Any single unspecified
`Total Degradates (%)
`Dissolution (W0431_011D)
`(Mean; Range)
`98 (92-101)
`5 min (%)
`101 (98-102)
`10 min (%)
`101 (100-102)
`15 min (%)
`101 (101-102)
`30 min (%)
`101 (101-102)
`60 min (%)
`† White, round, biconvex, film-coated tablet
`
`Conforms
`
`
`98.9
`0.9
`97.1-99.7
`
`None >0.1%
`0.0
`
`
`Conforms
`
`
`98.7
`1.6
`96.2-100.9
`
`None >0.1%
`0.0
`
`
`98 (97-101)
`100 (98-101)
`100 (99-101)
`100 (99-101)
`100 (99-101)
`
`Conforms
`
`
`97.6
`2.1
`95.5-102.4
`
`None >0.1%
`0.0
`
`
`98 (96-101)
`98 (96-102)
`98 (96-102)
`98 (96-102)
`98 (96-102)
`
`14-Nov-2005
`Final
`
`
`
`3.2.P.5.4 Batch Analyses
`
`
`
`Merck Exhibit 2108, Page 10
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
`
`MK-0431 Tablet
`3 Quality
`3.2.P.5.4 Batch Analyses
`
`
`11
`
`
`
`Potency
`Theoretical Batch Size (Tablets)
`Manufacturing Site
`Manufacturing Date
`Drug Substance Batch No.
`
`Table 3.2.P.5.4-0431-tablet: 3 (Cont.)
`
`Batch Analysis Results for MK-0431 Tablet (Anhydrous Form Drug Substance)
`Batch No.
`0431FCT001E001
`0431FCT001F001
`5 mg
`7.5 mg
`38,000
`38,000
`West Point, PA
`West Point, PA
`19FEB2003
`20FEB2003
`L-000224,715-
`L-000224,715-
`006F024
`006F024
`Clinical, Stability
`Clinical
`
`
`Conforms†
`Conforms†
`98.1
`97.0
`
`Studies Used In
`Analytical Procedure (Method #)
`Appearance
`Composite Assay (% label claim)
`(HPLC, W0431_009A)
`Identity
`Content Uniformity (HPLC,
`W0431_008U)
`Mean (% label claim)
`RSD (%)
`Range (%)
`Degradates
`Any single unspecified
`Total Degradates (%)
`Dissolution (W0431_006D)
`(Mean; Range)
`5 min (%)
`10 min (%)
`15 min (%)
`30 min (%)
`60 min (%)
`† White, round, biconvex, film-coated tablet
`
`Conforms
`
`
`98.2
`1.6
`95.2-100.6
`
`None >0.1%
`0.0
`
`
`81 (50-91)
`100 (99-101)
`100 (99-101)
`100 (99-101)
`100 (99-101)
`
`Conforms
`
`
`97.9
`0.8
`96.9-99.3
`
`None >0.1%
`0.0
`
`
`63 (54-73)
`98 (96-100)
`98 (96-100)
`98 (96-100)
`99 (97-101)
`
`
`
`3.2.P.5.4 Batch Analyses
`
`
`
`14-Nov-2005
`Final
`
`Merck Exhibit 2108, Page 11
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
`
`MK-0431 Tablet
`3 Quality
`3.2.P.5.4 Batch Analyses
`
`
`12
`
`
`
`Potency
`Theoretical Batch Size (Tablets)
`Manufacturing Site
`Manufacturing Date
`Drug Substance Batch No.
`
`Table 3.2.P.5.4-0431-tablet: 3 (Cont.)
`
`Batch Analysis Results for MK-0431 Tablet (Anhydrous Form Drug Substance)
`Batch No.
`0431FCT002F001
`0431FCT003F001
`0431FCT003F003
`7.5 mg
`7.5 mg
`7.5 mg
`140,000
`47,500
`47,500
`West Point, PA
`West Point, PA
`West Point, PA
`15JUL2003
`03NOV2003
`06JAN2004
`L-000224,715-
`L-000224,715-
`L-000224,715-
`006F024
`006F024
`006F029
`Clinical
`Clinical
`Clinical
`
`
`
`Conforms†
`Conforms†
`Conforms†
`98.3
`100.8
`98.3
`
`Studies Used In
`Analytical Procedure (Method #)
`Appearance
`Composite Assay (% label
`claim) (HPLC, W0431_009A)
`Identity
`Content Uniformity (HPLC,
`W0431_008U)
`Mean (% label claim)
`RSD (%)
`Range (%)
`Degradates
`Any single unspecified
`Total Degradates (%)
`Dissolution (W0431_011D)
`(Mean; Range)
`88 (83-93)
`5 min (%)
`101 (99-103)
`10 min (%)
`101 (99-103)
`15 min (%)
`101 (99-103)
`30 min (%)
`101 (100-103)
`60 min (%)
`† White, round, biconvex, film-coated tablet
`
`Conforms
`
`
`99.1
`0.9
`97.6-101.1
`
`None >0.1%
`0.0
`
`
`Conforms
`
`
`100.3
`1.4
`98.8-103.4
`
`None >0.1%
`0.0
`
`
`88 (81-98)
`103 (102-105)
`103 (102-105)
`103 (102-105)
`103 (102-105)
`
`Conforms
`
`
`98.2
`1.4
`96.3-100.2
`
`None >0.1%
`0.0
`
`
`100 (99-101)
`101 (99-102)
`101 (100-102)
`101 (100-102)
`101 (100-102)
`
`14-Nov-2005
`Final
`
`
`
`3.2.P.5.4 Batch Analyses
`
`
`
`Merck Exhibit 2108, Page 12
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
`
`MK-0431 Tablet
`3 Quality
`3.2.P.5.4 Batch Analyses
`
`
`13
`
`
`
`
`
`
`
`Potency
`Theoretical Batch Size (Tablets)
`Manufacturing Site
`Manufacturing Date
`Drug Substance Batch No.
`
`Table 3.2.P.5.4-0431-tablet: 3 (Cont.)
`
`Batch Analysis Results for MK-0431 Tablet (Anhydrous Form Drug Substance)
`Batch No.
`0431FCT002A001
`0431FCT002A002
`25 mg
`25 mg
`38,000
`38,000
`West Point, PA
`West Point, PA
`22JAN2003
`23JAN2003
`L-000224,715-
`L-000224,715-
`006F024
`006F024
`Clinical, Stability
`Clinical
`
`
`Conforms†
`Conforms†
`99.4
`99.4
`
`Studies Used In
`Analytical Procedure (Method #)
`Appearance
`Composite Assay (% label claim) (HPLC,
`W0431_009A)
`Identity
`Content Uniformity (HPLC, W0431_008U)
`Mean (% label claim)
`RSD (%)
`Range (%)
`Degradates
`Any single unspecified
`Total Degradates (%)
`Dissolution (W0431_006D) (Mean; Range)
`5 min (%)
`10 min (%)
`15 min (%)
`30 min (%)
`60 min (%)
`† White, round, biconvex, film-coated tablet
`
`Conforms
`
`99.4
`0.7
`98.5-100.7
`
`None >0.1%
`0.0
`
`41 (39-48)
`99 (99-100)
`99 (99-100)
`100 (99-100)
`99 (99-100)
`
`Conforms
`
`99.8
`0.5
`99.0-100.4
`
`None >0.1%
`0.0
`
`42 (35-48)
`99 (96-101)
`100 (99-101)
`100 (99-101)
`100 (99-101)
`
`3.2.P.5.4 Batch Analyses
`
`
`
`14-Nov-2005
`Final
`
`Merck Exhibit 2108, Page 13
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
`
`MK-0431 Tablet
`3 Quality
`3.2.P.5.4 Batch Analyses
`
`
`14
`
`
`
`Potency
`Theoretical Batch Size (Tablets)
`Manufacturing Site
`Manufacturing Date
`Drug Substance Batch No.
`
`Table 3.2.P.5.4-0431-tablet: 3 (Cont.)
`
`Batch Analysis Results for MK-0431 Tablet (Anhydrous Form Drug Substance)
`Batch No.
`0431FCT003A001
`0431FCT003A002
`0431FCT004A001
`25 mg
`25 mg
`25 mg
`120,000
`120,000
`140,000
`West Point, PA
`West Point, PA
`West Point, PA
`25APR2003
`28APR2003
`26AUG2003
`L-000224,715-
`L-000224,715-
`L-000224,715-
`006F023
`006F023
`006F029
`Clinical
`Clinical
`Clinical
`
`
`
`Conforms†
`Conforms†
`Conforms†
`96.3
`96.0
`99.3
`
`Studies Used In
`Analytical Procedure (Method #)
`Appearance
`Composite Assay (% label claim)
`(HPLC, W0431_009A)
`Identity
`Content Uniformity (HPLC,
`W0431_008U)
`Mean (% label claim)
`RSD (%)
`Range (%)
`Degradates
`Any single unspecified
`Total Degradates (%)
`Dissolution (W0431_011D)
`(Mean; Range)
`96 (91-100)
`5 min (%)
`100 (100-101)
`10 min (%)
`100 (100-101)
`15 min (%)
`100 (100-101)
`30 min (%)
`100 (100-101)
`60 min (%)
`† White, round, biconvex, film-coated tablet
`
`Conforms
`
`
`97.9
`0.6
`96.8-98.7
`
`None >0.1%
`0.0
`
`
`Conforms
`
`
`98.0
`3.3
`95.6-106.8
`
`None >0.1%
`0.0
`
`
`61 (51-99)
`99 (99-100)
`100 (99-101)
`100 (99-101)
`100 (99-101)
`
`Conforms
`
`
`99.8
`1.2
`97.7-101.4
`
`None >0.1%
`0.1
`
`
`89 (79-100)
`101 (98-102)
`101 (98-102)
`101 (99-102)
`101 (99-102)
`
`14-Nov-2005
`Final
`
`
`
`3.2.P.5.4 Batch Analyses
`
`
`
`Merck Exhibit 2108, Page 14
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
`
`MK-0431 Tablet
`3 Quality
`3.2.P.5.4 Batch Analyses
`
`
`15
`
`
`
`Potency
`Theoretical Batch Size (Tablets)
`Manufacturing Site
`Manufacturing Date
`Drug Substance Batch No.
`
`Table 3.2.P.5.4-0431-tablet: 3 (Cont.)
`
`Batch Analysis Results for MK-0431 Tablet (Anhydrous Form Drug Substance)
`Batch No.
`0431FCT004A002
`0431FCT004A003
`0431FCT004A004
`25 mg
`25 mg
`25 mg
`140,000
`140,000
`140,000
`West Point, PA
`West Point, PA
`West Point, PA
`29SEP2003
`30SEP2003
`06JAN2004
`L-000224,715-
`L-000224,715-
`L-000224,715-
`006F029
`006F029
`006F029
`Clinical
`Clinical
`Clinical
`
`
`
`Conforms†
`Conforms†
`Conforms†
`99.4
`99.1
`98.6
`
`Conforms
`
`
`99.2
`1.1
`97.9-101.7
`
`None >0.1%
`0.0
`
`
`57 (42-69)
`101 (99-103)
`102 (101-103)
`102 (101-103)
`102 (101-103)
`
`Conforms
`
`
`98.3
`1.0
`97.0-100.2
`
`None >0.1%
`0.0
`
`
`96 (86-101)
`100 (100-101)
`100 (100-101)
`100 (100-101)
`100 (100-101)
`
`Studies Used In
`Analytical Procedure (Method #)
`Appearance
`Composite Assay (% label claim)
`(HPLC, W0431_009A)
`Identity
`Content Uniformity (HPLC,
`W0431_008U)
`Mean (% label claim)
`RSD (%)
`Range (%)
`Degradates
`Any single unspecified
`Total Degradates (%)
`Dissolution (W0431_011D)
`(Mean; Range)
`67 (56-81)
`5 min (%)
`101 (99-102)
`10 min (%)
`101 (101-102)
`15 min (%)
`101 (100-102)
`30 min (%)
`101 (101-102)
`60 min (%)
`† White, round, biconvex, film-coated tablet
`
`Conforms
`
`
`99.4
`1.7
`95.0-101.1
`
`None >0.1%
`0.0
`
`
`
`
`3.2.P.5.4 Batch Analyses
`
`
`
`14-Nov-2005
`Final
`
`Merck Exhibit 2108, Page 15
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
`
`MK-0431 Tablet
`3 Quality
`3.2.P.5.4 Batch Analyses
`
`
`16
`
`
`
`Table 3.2.P.5.4-0431-tablet: 3 (Cont.)
`
`Batch Analysis Results for MK-0431 Tablet (Anhydrous Form Drug Substance)
`Batch No.
`0431FCT004A005
`25 mg
`140,000
`West Point, PA
`06JAN2004
`L-000224,715-006F029
`Clinical
`
`Conforms†
`99.2
`Conforms
`
`99.1
`1.0
`97.2-100.6
`
`None >0.1%
`0.0
`
`84 (71-96)
`102 (100-103)
`102 (101-103)
`102 (101-103)
`102 (101-103)
`
`Potency
`Theoretical Batch Size (Tablets)
`Manufacturing Site
`Manufacturing Date
`Drug Substance Batch No.
`Studies Used In
`Analytical Procedure (Method #)
`Appearance
`Composite Assay (% label claim) (HPLC, W0431_009A)
`Identity
`Content Uniformity (HPLC, W0431_008U)
`Mean (% label claim)
`RSD (%)
`Range (%)
`Degradates
`Any single unspecified
`Total Degradates (%)
`Dissolution (W0431_011D) (Mean; Range)
`5 min (%)
`10 min (%)
`15 min (%)
`30 min (%)
`60 min (%)
`† White, round, biconvex, film-coated tablet
`
`
`
`3.2.P.5.4 Batch Analyses
`
`
`
`14-Nov-2005
`Final
`
`Merck Exhibit 2108, Page 16
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
`
`MK-0431 Tablet
`3 Quality
`3.2.P.5.4 Batch Analyses
`
`
`17
`
`
`
`Potency
`Theoretical Batch Size (Tablets)
`Manufacturing Site
`Manufacturing Date
`Drug Substance Batch No.
`
`Table 3.2.P.5.4-0431-tablet: 3 (Cont.)
`
`Batch Analysis Results for MK-0431 Tablet (Anhydrous Form Drug Substance)
`Batch No.
`0431FCT001B001
`0431FCT002B001
`50 mg
`50 mg
`5,000
`12,500
`West Point, PA
`West Point, PA
`18SEP2002
`21NOV2002
`L-000224,715-
`L-000224,715-
`006F017
`006F017
`Clinical, Stability
`Clinical
`
`
`Conforms†
`Conforms†
`100.9
`100.7
`
`Studies Used In
`Analytical Procedure (Method #)
`Appearance
`Composite Assay (% label claim) (HPLC,
`W0431_009A)
`Identity
`Content Uniformity (HPLC, W0431_008U)
`Mean (% label claim)
`RSD (%)
`Range (%)
`Degradates
`Any single unspecified
`Total Degradates (%)
`Dissolution (W0431_006D) (Mean; Range)
`5 min (%)
`10 min (%)
`15 min (%)
`30 min (%)
`60 min (%)
`† White, round, biconvex, film-coated tablet
`
`Conforms
`
`102.7
`3.4
`98.4–115.1
`
`None >0.1%
`0.0
`
`84 (69-91)
`102 (101-103)
`102 (101-103)
`102 (101-104)
`102 (101-103)
`
`Conforms
`
`99.2
`2.6
`95.8-105.2
`
`None >0.1%
`0.0
`
`45 (40-52)
`101 (99-104)
`101 (100-104)
`101 (100-104)
`101 (100-104)
`
`3.2.P.5.4 Batch Analyses
`
`
`
`14-Nov-2005
`Final
`
`Merck Exhibit 2108, Page 17
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
`
`MK-0431 Tablet
`3 Quality
`3.2.P.5.4 Batch Analyses
`
`
`18
`
`
`
`Potency
`Theoretical Batch Size (Tablets)
`Manufacturing Site
`Manufacturing Date
`Drug Substance Batch No.
`
`Table 3.2.P.5.4-0431-tablet: 3 (Cont.)
`
`Batch Analysis Results for MK-0431 Tablet (Anhydrous Form Drug Substance)
`Batch No.
`0431FCT003B001
`0431FCT003B002
`0431FCT004B001
`50 mg
`50 mg
`50 mg
`30,000
`30,000
`100,000
`West Point, PA
`West Point, PA
`West Point, PA
`06MAY2003
`06MAY2003
`21JUL2003
`L-000224,715-
`L-000224,715-
`L-000224,715-
`006F023
`006F023
`006F029
`Clinical
`Clinical
`Clinical
`
`
`
`Conforms†
`Conforms†
`Conforms†
`96.5
`97.8
`99.5
`
`Conforms
`
`
`98.4
`0.8
`97.4-99.8
`
`None >0.1%
`0.0
`
`
`52 (46-59)
`100 (99-101)
`100 (99-101)
`100 (100-101)
`100 (100-101)
`
`Conforms
`
`
`99.5
`0.6
`98.8-100.9
`
`None >0.1%
`0.0
`
`
`70 (52-92)
`100 (99-100)
`100 (99-101)
`100 (99-101)
`100 (99-101)
`
`Studies Used In
`Analytical Procedure (Method #)
`Appearance
`Composite Assay (% label claim)
`(HPLC, W0431_009A)
`Identity
`Content Uniformity (HPLC,
`W0431_008U)
`Mean (% label claim)
`RSD (%)
`Range (%)
`Degradates
`Any single unspecified
`Total Degradates (%)
`Dissolution (W0431_006D)
`(Mean; Range)
`47 (41-53)
`5 min (%)
`99 (97-101)
`10 min (%)
`100 (99-101)
`15 min (%)
`100 (99-101)
`30 min (%)
`100 (99-101)
`60 min (%)
`† White, round, biconvex, film-coated tablet
`
`Conforms
`
`
`98.2
`0.5
`97.4-99.1
`
`None >0.1%
`0.0
`
`
`3.2.P.5.4 Batch Analyses
`
`
`
`14-Nov-2005
`Final
`
`Merck Exhibit 2108, Page 18
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
`
`MK-0431 Tablet
`3 Quality
`3.2.P.5.4 Batch Analyses
`
`
`19
`
`
`
`Potency
`Theoretical Batch Size (Tablets)
`Manufacturing Site
`Manufacturing Date
`Drug Substance Batch No.
`
`Table 3.2.P.5.4-0431-tablet: 3 (Cont.)
`
`Batch Analysis Results for MK-0431 Tablet (Anhydrous Form Drug Substance)
`Batch No.
`0431FCT007B001
`0431FCT004B003
`0431FCT004B002
`50 mg
`50 mg
`50 mg
`12,500
`100,000
`100,000
`West Point, PA
`West Point, PA
`West Point, PA
`24NOV2003
`14JAN2004
`27AUG2003
`L-000224,715-
`L-000224,715-
`L-000224,715-
`006F024
`006F029
`006F029
`Clinical
`Clinical
`Clinical
`
`
`
`Conforms†
`Conforms†
`Conforms†
`98.4
`99.1
`99.1
`
`Studies Used In
`Analytical Procedure (Method #)
`Appearance
`Composite Assay (% label claim)
`(HPLC, W0431_009A)
`Identity
`Content Uniformity (HPLC,
`W0431_008U)
`Mean (% label claim)
`RSD (%)
`Range (%)
`Degradates
`Any single unspecified
`Total Degradates (%)
`Dissolution (W0431_006D)
`(Mean; Range)
`64 (50-79)
`5 min (%)
`101 (100-102)
`10 min (%)
`101 (100-102)
`15 min (%)
`101 (100-102)
`30 min (%)
`101 (100-102)
`60 min (%)
`† White, round, biconvex, film-coated tablet
`
`Conforms
`
`
`95.0
`0.9
`93.8-96.8
`
`None >0.1%
`0.0
`
`
`Conforms
`
`
`98.0
`2.7
`84.9-99.9
`
`None >0.1%
`0.0
`
`
`36 (32-41)
`98 (94-100)
`99 (98-100)
`99 (98-100)
`99 (98-100)
`
`Conforms
`
`
`99.5
`1.7
`96.1-101.2
`
`None >0.1%
`0.0
`
`
`53 (44-58)
`100 (95-102)
`101 (97-102)
`101 (99-102)
`101 (100-103)
`
`14-Nov-2005
`Final
`
`
`
`3.2.P.5.4 Batch Analyses
`
`
`
`Merck Exhibit 2108, Page 19
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
`
`MK-0431 Tablet
`3 Quality
`3.2.P.5.4 Batch Analyses
`
`
`20
`
`
`
`Potency
`Theoretical Batch Size (Tablets)
`Manufacturing Site
`Manufacturing Date
`Drug Substance Batch No.
`
`Table 3.2.P.5.4-0431-tablet: 3 (Cont.)
`
`Batch Analysis Results for MK-0431 Tablet (Anhydrous Form Drug Substance)
`Batch No.
`0431FCT001C001
`0431FCT002C004
`100 mg
`100 mg
`30,000
`35,000
`West Point, PA
`West Point, PA
`17DEC2002
`13JAN2004
`L-000224,715-
`L-000224,715-
`006F024
`006F029
`Clinical, Stability
`Clinical
`
`
`Conforms†
`Conforms†
`98.9
`99.9
`
`Studies Used In
`Analytical Procedure (Method #)
`Appearance
`Composite Assay (% label claim)
`(HPLC, W0431_009A)
`Identity
`Content Uniformity (HPLC,
`W0431_008U)
`Mean (% label claim)
`RSD (%)
`Range (%)
`Degradates
`Any single unspecified
`Total Degradates (%)
`Dissolution (W0431_006D)
`(Mean; Range)
`5 min (%)
`10 min (%)
`15 min (%)
`30 min (%)
`60 min (%)
`† White, round, biconvex, film-coated tablet
`
`Conforms
`
`
`102.8
`1.7
`98.9-105.3
`
`None >0.1%
`0.0
`
`
`31 (21-38)
`98 (91-102)
`99 (97-101)
`100 (98-102)
`100 (98-102)
`
`Conforms
`
`
`98.5
`0.5
`97.6-99.5
`
`None >0.1%
`0.0
`
`
`37 (35-44)
`98 (97-99)
`98 (98-99)
`98 (98-99)
`99 (98-99)
`
`
`
`3.2.P.5.4 Batch Analyses
`
`
`
`14-Nov-2005
`Final
`
`Merck Exhibit 2108, Page 20
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
`
`MK-0431 Tablet
`3 Quality
`3.2.P.5.4 Batch Analyses
`
`
`21
`
`
`
`Potency
`Theoretical Batch Size (Tablets)
`Manufacturing Site
`Manufacturing Date
`Drug Substance Batch No.
`
`Table 3.2.P.5.4-0431-tablet: 3 (Cont.)
`
`Batch Analysis Results for MK-0431 Tablet (Anhydrous Form Drug Substance)
`Batch No.
`0431FCT002C001
`0431FCT002C002
`100 mg
`100 mg
`35,000
`35,000
`West Point, PA
`West Point, PA
`28JAN2003
`29JAN2003
`L-000224,715-
`L-000224,715-
`006F024
`006F024
`Clinical
`Clinical
`
`
`Conforms†
`Conforms†
`99.6
`98.8
`
`Studies Used In
`Analytical Procedure (Method #)
`Appearance
`Composite Assay (% label claim) (HPLC,
`W0431_009A)
`Identity
`Content Uniformity (HPLC, W0431_008U)
`Mean (% label claim)
`RSD (%)
`Range (%)
`Degradates
`Any single unspecified
`Total Degradates (%)
`Dissolution (W0431_011D) (Mean; Range)
`5 min (%)
`10 min (%)
`15 min (%)
`30 min (%)
`60 min (%)
`† White, round, biconvex, film-coated tablet
`
`Conforms
`
`99.8
`1.2
`98.0-102.2
`
`None >0.1%
`0.0
`
`38 (35-40)
`100 (99-102)
`102 (100-104)
`102 (100-104)
`102 (100-104)
`
`Conforms
`
`99.1
`0.6
`98.3-100.0
`
`None >0.1%
`0.0
`
`35 (24-40)
`98 (92-101)
`100 (100-101)
`101 (100-101)
`101 (100-101)
`
`3.2.P.5.4 Batch Analyses
`
`
`
`14-Nov-2005
`Final
`
`Merck Exhibit 2108, Page 21
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
`
`MK-0431 Tablet
`3 Quality
`3.2.P.5.4 Batch Analyses
`
`
`22
`
`
`
`Table 3.2.P.5.4-0431-tablet: 4
`
`Batch Analysis Results for MK-0431 Tablet (Monohydrate Form Drug Substance)
`
`Batch No.
`
`Potency
`Theoretical Batch Size (Tablets)
`Manufacturing Site
`Manufacturing Date
`Drug Substance Batch No.
`
`0431FCT007A002
`25 mg
`401,250
`West Point, PA
`17AUG2004
`L-000224,715-
`010X026
`Stability†
`
`Conforms‡
`99.9
`
`0431FCT007A001
`25 mg
`401,250
`West Point, PA
`16AUG2004
`L-000224,715-
`010X025
`Clinical, Stability†
`
`Conforms‡
`99.3
`
`Studies Used In
`Analytical Procedure (Method #)
`Appearance
`Composite Assay (% label claim)
`(HPLC, W0431_034A)
`Identity
`Content Uniformity (HPLC,
`W0431_038U)
`Mean (% label claim)
`RSD (%)
`Range (%)
`Degradates
`Any single unspecified (%)
`Total Degradates (%)
`Dissolution (W0431_039D)
`(Mean; Range)
`10 min (%)
`15 min (%)
`20 min (%)
`30 min (%)
`Disintegration (W0431_050P)
`Mean (minutes)
`Range (minutes)
`† Used in formal stability study.
`‡ Pink, round, biconvex, film-coated tablet with “211” on one side and plain on the other
`
`Conforms
`
`
`100.4
`1.9
`97.1-105.2
`
`0.0
`0.0
`
`
`97 (96-101)
`99 (98-103)
`100 (99-103)
`102 (100-106)
`
`1.27
`1.00 - 1.50
`
`Conforms
`
`
`99.4
`1.9
`95.5-103.4
`
`0.0
`0.0
`
`
`98 (97-101)
`100 (97-102)
`101 (99-104)
`103 (101-105)
`
`1.29
`1.25 – 1.50
`
`0431FCT007A003
`25 mg
`401,250
`West Point, PA
`18AUG2004
`L-000224,715-
`010X027
`Stability†
`
`Conforms‡
`100.5
`
`Conforms
`
`
`100.2
`1.9
`96.6 -104.6
`
`0.0
`0.0
`
`
`95 (94-96)
`97 (96-99)
`99 (97-100)
`101 (99-102)
`
`1.29
`1.25 – 1.50
`
`3.2.P.5.4 Batch Analyses
`
`
`
`14-Nov-2005
`Final
`
`Merck Exhibit 2108, Page 22
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
`
`MK-0431 Tablet
`3 Quality
`3.2.P.5.4 Batch Analyses
`
`
`23
`
`
`
`Table 3.2.P.5.4-0431-tablet: 4 (Cont.)
`
`Batch Analysis Results for MK-0431 Tablet (Monohydrate Form Drug Substance)
`Batch No.
`0431FCT005A001
`0431FCT008B001
`0431FCT009B001
`25 mg
`50 mg
`50 mg
`1,344,000
`84,560
`588,000
`West Point, PA
`West Point, PA
`West Point, PA
`20FEB2004
`20JAN2004
`18FEB2004
`L-000224,715-
`L-000224,715-
`L-000224,715-
`010X023
`010X012
`010X023
`Clinical
`Clinical
`Clinical
`
`
`
`
`Potency
`Theoretical Batch Size (Tablets)
`Manufacturing Site
`Manufacturing Date
`Drug Substance Batch No.
`
`Studies Used In
`Analytical Procedure (Method
`#)
`Appearance
`Composite Assay (% label
`claim) (HPLC, W0431_015A)
`Identity
`Content Uniformity (HPLC,
`W0431_017U)
`Mean (% label claim)
`RSD (%)
`Range (%)
`Degradates
`Any single unspecified (%)
`Total Degradates (%)
`Dissolution (W0431_019D)
`(Mean; Range)
`99 (97-102)
`95 (86-101)
`10 min (%)
`99 (97-102)
`100 (94-102)
`15 min (%)
`99 (97-102)
`101 (100-102)
`20 min (%)
`99 (97-102)
`101 (100-103)
`30 min (%)
`99 (97-102)
`101 (100-103)
`60 min (%)
`† White, round, biconvex film-coated tablet with “211” on one side and plain on the other
`‡ White, round, biconvex film-coated tablet with “112” on one side and plain on the other
`
`
`Conforms†
`99.8
`
`Conforms
`
`
`99.9
`2.1
`96.7-103.3
`
`0.0
`0.0
`
`
`Conforms‡
`99.7
`
`Conforms
`
`
`98.9
`1.2
`96.8-101.1
`
`0.0
`0.0
`
`
`Conforms‡
`98.4
`
`Conforms
`
`
`98.2
`1.0
`96.3-99.4
`
`0.0
`0.0
`
`
`96 (92-100)
`99 (97-100)
`99 (98-100)
`99 (98-100)
`99 (98-100)
`
`3.2.P.5.4 Batch Analyses
`
`
`
`14-Nov-2005
`Final
`
`Merck Exhibit 2108, Page 23
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
`
`MK-0431 Tablet
`3 Quality
`3.2.P.5.4 Batch Analyses
`
`
`24
`
`
`
`Potency
`Theoretical Batch Size (Tablets)
`Manufacturing Site
`Manufacturing Date
`Drug Substance Batch No.
`
`Table 3.2.P.5.4-0431-tablet: 4 (Cont.)
`
`Batch Analysis Results for MK-0431 Tablet (Monohydrate Form Drug Substance)
`Batch No.
`0431FCT011B001
`0431FCT011B002
`0431FCT011B003
`50 mg
`50 mg
`50 mg
`630,000
`630,000
`630,000
`West Point, PA
`West Point, PA
`West Point, PA
`03MAY2004
`04MAY2004
`05MAY2004
`L-000224,715-
`L-000224,715-
`L-000224,715-
`010X025
`010X026
`010X027
`Stability†
`Stability†
`Clinical,
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