EXHIBIT 2029
`
`EXHIBIT 2029
`
`
`
`

`
`THISSEN Laboratories s.
`THISSEN Laboratories s.
`
`Rue de la Papyree 2-6
`Rue de la Papyree 2-6
`B-1420 BRAINE L'ALLEUD
`B-1420 BRAINE L'ALLEUD
`
`Tel : (cid:9)Tel : (cid:9)
`
`32.2.386.1211 32.2.386.1211
`Fax (cid:9)
`Fax (cid:9)
`32.2.38517 82
`32.2.38517 82
`
`SDX 105 FOR INJECTION
`SDX 105 FOR INJECTION
`
`
`
`BATCH : 03H08 BATCH : 03H08
`
`TEST PARAMETER
`TEST PARAMETER
`
`TEST METHOD
`TEST METHOD
`
`RELEASE SPECIFICATION
`RELEASE SPECIFICATION
`
`RESULTS
`RESULTS
`
`General and specific characteristics
`General and specific characteristics
`
`Appearance
`Appearance
`
`
`
`Visual examination
`Visual examination
`
`Uniformity of dosage units
`Uniformity of dosage units
`
`
`
`Constituted solution Constituted solution
`
`
`
`pH value after reconstitution pH value after reconstitution
`
`
`
`Identity Identity
`
`USP <905>
`USP <905>
`
`USP <1>
`USP <1>
`
`USP <791>
`USP <791>
`
`
`
`
`White, White, microcrystalline microcrystalline
`lyophilisate
`lyophilisate
`
`Complies Complies
`
`
`
`Complies Complies
`
`2.5 - 3.5
`2.5 - 3.5
`
`
`
`Complies Complies
`
`
`
`Complies Complies
`
`
`
`Complies Complies
`
`
`
`3.2 3.2
`
`Bendamustine hydrochloride
`Bendamustine hydrochloride
`
`
`
`HPLC HPLC
`
`
`
`Complies with standard Complies with standard
`
`Complies
`Complies
`
`Assay
`Assay
`
`Bendamustine hydrochloride
`Bendamustine hydrochloride
`
`HPI.0
`HPI.0
`
`
`100. 0 mg / v ial 100. 0 mg / v ial
`95.0 — 105.0 mg/vial
`95.0 — 105.0 mg/vial
`
`
`
`Purity Purity
`
`
`
`Water content Water content
`
`Related substances
`Related substances
`
`HP1
`HP1
`
`HP2
`HP2
`
`
`
`HP3 HP3
`
`USP <921> method 1
`USP <921> method 1
`
`Max 2.5 "/0
`Max 2.5 "/0
`
`HPLC
`HPLC
`
`Max 3.3 %
`Max 3.3 %
`
`Max 0.5 0/
`Max 0.5 0/
`
`
`
`Max 0.1 % Max 0.1 %
`
`98.4
`98.4
`
`0.9
`0.9
`
`1.8
`1.8
`
`ND
`ND
`
`ND
`ND
`
`
`
`NP1 NP1
`
`
`
`BMI EE BMI EE
`
`
`
`BM1 DIMER BM1 DIMER
`
`
`
`BM1 DCE BM1 DCE
`
`
`
`HBI HBI
`
`Not identified single peaks
`Not identified single peaks
`
`Sum of not identified peaks
`Sum of not identified peaks
`
`Sum of all secondary peaks
`Sum of all secondary peaks
`
`Sterility
`Sterility
`
`Bacterial endotoxines
`Bacterial endotoxines
`
`Particulate matter
`Particulate matter
`
`
`
`USP <71> USP <71>
`
`
`
`USP <85> USP <85>
`
`
`
`USP <788> USP <788>
`
`<LOQ
`<LOQ
`
`0.2
`0.2
`
`0.3
`0.3
`
`
`
`ND ND
`
`
`
`ND ND
`
`
`
`ND ND
`
`
`
`ND ND
`
`
`
`2.3 2.3
`
`
`
`Complies Complies
`
`
`
`< 0.192 < 0.192
`
`
`
`Complies Complies
`
`
`
`Max 0.5 % Max 0.5 %
`
`
`
`Max 0.6 % Max 0.6 %
`
`
`
`Max 0.7 °Jo Max 0.7 °Jo
`
`
`
`Max 0.1 % Max 0.1 %
`
`
`
`Max 0.5 % Max 0.5 %
`
`
`
`Max 0.1 °'0 Max 0.1 °'0
`
`
`
`Max 0.5 % Max 0.5 %
`
`
`
`Max 5.0 % Max 5.0 %
`
`
`
`Sterile Sterile
`
`
`
`Max 0.5 I.U. / mg Max 0.5 I.U. / mg
`
`
`
`Complies Complies
`
`
`Michel HUME Michel HUME
`Quality Director
`Quality Director
`
`Responsible Pharmacist Responsible Pharmacist
`
`CEPHALON, INC. -- EXHIBIT 2029 0001
`
`

`
`
`
`Fujisawa Deutschland GmbH Fujisawa Deutschland GmbH
`
`CERTIFICATE OF ANALYSIS CERTIFICATE OF ANALYSIS
`
`
`Bendamustin 100 mg for injection, Batch no. 03H08 Bendamustin 100 mg for injection, Batch no. 03H08
`Expiry Date: 08.2005
`Expiry Date: 08.2005
`TI no.: 3.0
`TI no.: 3.0
`
`
`
`Test parameter Test parameter
`
`
`
`General characteristics General characteristics
`
`Appearance
`Appearance
`
`Average mass
`Average mass
`
`
`
`Uniformity of mass Uniformity of mass
`
`Solubility
`Solubility
`
`Clarity after reconstitution
`Clarity after reconstitution
`
`Colour after reconstitution
`Colour after reconstitution
`
`pH-value after reconstitution
`pH-value after reconstitution
`
`Identity
`Identity
`
`- Chloride - Chloride
`
`- Bendamustine hydrochloride - Bendamustine hydrochloride
`Purity
`Purity
`Related substances
`Related substances
`- (cid:9)
`- (cid:9)
`
`HP 1 HP 1
`
`- (cid:9)- (cid:9)
`
`HP 2 HP 2
`- (cid:9)
`- (cid:9)
`NP 1
`NP 1
`BM1 EE
`BM1 EE
`
`HBI HBI
`Not identified singel peaks
`Not identified singel peaks
`
`Sum of not identified peaks Sum of not identified peaks
`
`Sum of all secondary peaks Sum of all secondary peaks
`
`Water content Water content
`Sterility
`Sterility
`Endotoxins
`Endotoxins
`
`Assay Assay
`
`Bendamustine hydrochloride Bendamustine hydrochloride
`
`Specification
`Specification
`.. (cid:9)
`.. (cid:9)
`
`_ Result
`_ Result
`
`
`
`white, microcrystalline lyophilisate white, microcrystalline lyophilisate
`
`
`
`complies complies
`
`198.0 - 242.0 mg
`198.0 - 242.0 mg
`
`complies with Ph. Eur. 2.9.5
`complies with Ph. Eur. 2.9.5
`
`soluble within 5 minutes without
`soluble within 5 minutes without
`residues
`residues
`
`clear
`clear
`
`5 B 6
`5 B 6
`
`
`
`2.5 - 3.5 2.5 - 3.5
`
`positive
`positive
`complies with standard
`complies with standard
`
`max. 3.5 %
`max. 3.5 %
`max. 0.5 %
`max. 0.5 %
`
`max. 0.5 % max. 0.5 %
`max. 0.5 %
`max. 0.5 %
`max. 0.5 %
`max. 0.5 %
`max. 0.2 %
`max. 0.2 %
`
`max. 0.5 % max. 0.5 %
`max. 5.0 %
`max. 5.0 %
`
`max. 2.5 % max. 2.5 %
`sterile, complies with Ph. Eur. 2.6.1
`sterile, complies with Ph. Eur. 2.6.1
`
`not more than 0.5 I.U. / mg not more than 0.5 I.U. / mg
`
`221.6 mg
`221.6 mg
`
`complies
`complies
`
`
`
`complies complies
`
`complies
`complies
`
`
`
`complies complies
`
`3.2
`3.2
`
`
`complies complies
`
`complies complies
`
`
`1.8 % 1.8 %
`n.d.
`n.d.
`<LOQ
`<LOQ
`0.2 %
`0.2 %
`
`n.d. n.d.
`n.d.
`n.d.
`0.3 %
`0.3 %
`
`2.3 % 2.3 %
`0.9 %
`0.9 %
`
`complies complies
`complies
`complies
`
`100.0 mg / vial
`100.0 mg / vial
`
`(limits: 95.0 - 105.0 mg / vial ) (limits: 95.0 - 105.0 mg / vial )
`
`98.4 mg / vial
`98.4 mg / vial
`
`
`We herewith confirm that this batch was manufactured and tested in accordance with the relevant We herewith confirm that this batch was manufactured and tested in accordance with the relevant
`
`GM P requirements. GM P requirements.
`Status: Approved for clinical trials
`Status: Approved for clinical trials
`
`
`
`Munich, October 2nd, 2003 Munich, October 2nd, 2003
`
`
`Dr. Unterlinner Dr. Unterlinner
`
`Head of Product Release/GC Head of Product Release/GC
`
`
`Fuchs Fuchs
`
`Product Documentation/QC Product Documentation/QC
`
`
`Adminatralive headquarters: Adminatralive headquarters:
`
`Elerg•am4.arm•Strasse Elerg•am4.arm•Strasse
`
`129 129
`
`041673 Munchen 041673 Munchen
`
`Telefax: +49(0)89 45 44.13 29 Telefax: +49(0)89 45 44.13 29
`
`
`Operations: Operations:
`
`Weihenstephanei Sousse 28 Weihenstephanei Sousse 28
`
`0-81673 Munchen 0-81673 Munchen
`
`Telefax: +49(0)89 45 44.15 95 Telefax: +49(0)89 45 44.15 95
`
`
`Telephone: Telephone:
`
`.49(0)8945 44.01 .49(0)8945 44.01
`
`VA T. No: VA T. No:
`
`DE 8111138277 DE 8111138277
`
`
`E 4nail E 4nail
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`inlofxrupsawa.deutschtend de inlofxrupsawa.deutschtend de
`
`Weusite: Weusite:
`
`wenvlupsawa.cleuischland.de wenvlupsawa.cleuischland.de
`
`
`Destine? Bank Munchen Destine? Bank Munchen
`
`acct. N 03 017 825 00 acct. N 03 017 825 00
`
`Bank ID Code: 700 80000 Bank ID Code: 700 80000
`SWIFT address: ORES OE FF 700
`SWIFT address: ORES OE FF 700
`
`Suidtsparkasse Munchen
`Suidtsparkasse Munchen
`acct I 39.180 039
`acct I 39.180 039
`Bank ID Code: 701 50000
`Bank ID Code: 701 50000
`SWIFTaddresa SSKM DE MM AXX
`SWIFTaddresa SSKM DE MM AXX
`
`
`Company Seal: Munchen • Incorporated al the Court Registry in Munchen HR B 67 708 • President' (k Wolfgang Tiiihnt • Executive Vice President Diet .Klm Wollgang Schoch Company Seal: Munchen • Incorporated al the Court Registry in Munchen HR B 67 708 • President' (k Wolfgang Tiiihnt • Executive Vice President Diet .Klm Wollgang Schoch
`
`Executive Directors. Orpl..10m Norbert Fischer • Or. Erich Karmen • Or Fritz Slarristaus Executive Directors. Orpl..10m Norbert Fischer • Or. Erich Karmen • Or Fritz Slarristaus
`
`CEPHALON, INC. -- EXHIBIT 2029 0002