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`
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`EXHIBIT 2028EXHIBIT 2028
`
`
`
`
`
`
`
`THISSEN Laboratories s. a.
`
`Rue de la Papyree 2-6
`15-1420 BRAINE L'AU_EUD
`32-2-3E6.12.11
`32-2-385.17
`
`Fax • (cid:9)
`
`Nr. Of Analysis : 023303
`
`Ribomustin 100 mg Freeze-dried powder
`
`BATCH : 03C08
`
`Manufacture 08/03/2003 - Expiration 03/2005
`
`TEST PARAMETER TEgr METHOD
`
`RELEASE
`SPECIFICATION
`
`RESULTS
`
`General and specific characteristics
`Visual examination White, microcrystalline
`lyophilate
`
`Appearance
`
`Complies
`
`Uniformity of Dosag5
`Units
`Constituted solution
`pH value after
`teLonsinution
`Identity
`Benda/nu[..toe
`hpixochionde
`Assay
`Bendamustine (cid:9)
`hydrochloride
`Purity
`
`Water content
`
`Related substances
`HP1
`14P2
`HP3
`NP1
`BM1 ER
`BM1 DIMER (cid:9)
`BM1 DCE
`fiBI
`Not identified single
`peaks
`Sum of not identified
`peaks
`Sum of all secondary
`peaks
`
`•
`
`usp <905>
`
`USP <1>
`
`Complies with USP <905>
`
`Complies
`
`Complies with USP <1>
`
`Complies
`
`USP <791>
`
`2.5 — 3.5
`
`3.2
`
`HPLC
`
`1
`
`HPLC
`
`Complies with staniiird
`
`Complies
`
`100.0 trig/vial
`(limits : 95.0 — 105.0 mg/vial)
`
`100.0
`
`USP <921> method
`1
`
`Max. 25 %
`
`HPLC
`
`Max 3.3 %
`Max 0.5 1/4
`Max 0.1 %
`Max 05 %
`Max 0.6 %
`Max 0.7 %
`Max 0.1'
`Max 05 %
`Max 0.1 1/4
`
`Max 0.5 1/4
`
`Max 5.0 1/4
`
`1
`
`0.9
`
`1.4
`ND
`ND
`<LOQ
`0.2
`0.4
`ND
`ND
`Ni)
`
`0.4
`
`1.9
`
`Sterility
`
`USP <71>
`
`Sterile
`
`Complies
`
`Bacterial Eridotoxins
`
`USP <85>
`
`Not more than 05 131/mg
`
`<0.192
`
`Conclusion : this batch was release on 17/04/2003 (cid:9)
`
`ponsible Pharmacist, M. RUNE.
`
`,eptie 6tf 3
`
`•
`
`•
`
`CEPHALON, INC. -- EXHIBIT 2028 0001
`
`
`
`"di Fujisawa Deutschland GmbH
`
`CERTIFICATE OF ANALYSIS
`
`Bendamustin 100 mg for injection, Batch no. 03C08
`Expiry Date: 03.2005
`TI no.: 3.0
`
`Test parameter
`
`Specification
`
`Result
`
`General characteristics
`
`Appearance
`
`Average mass
`
`Uniformity of mass
`
`Solubility
`
`white, microcrystalline lyophilisate
`
`complies
`
`198.0 — 242.0 mg
`
`complies with Ph. Eur. 2.9.5
`
`soluble within 5 minutes without
`residues
`
`221.8 mg
`
`complies
`
`complies
`
`complies
`
`complies
`
`3.2
`
`complies
`complies
`
`1.4 %
`n.d.
`<LOQ
`0.2%
`n.d.
`n.d.
`0.4 %
`1.9 %
`0.9 %
`complies
`complies
`
`Clarity after reconstitution
`
`Colour after reconstitution
`
`clear
`
`5 B 6
`
`pH-value after reconstitution
`
`2.5 — 3.5
`
`Identity
`- Chloride
`- Bendamustine hydrochloride
`Purity
`Related substances
`HP 1
`HP 2
`NP 1
`BM1EE
`HBI
`Not identified singe! peaks
`Sum of not identified peaks
`Sum of all secondary peaks
`Water content
`Stsrility
`Endotoxins
`As y
`Bendamustine hydrochloride
`
`positive
`complies with standard
`
`max. 3.5 %
`max. 0.5 %
`max. 0.5 %
`max. 0.5 %
`max. 0.5 %
`max. 0.2 %
`max. 0.5 %
`max. 5.0 %
`max. 2.5 %
`sterile, complies with Ph. Eur. 2.6.1
`not more than 0.5 I.U. / mg
`
`100.0 mg / vial
`(limits: 95.0 — 105.0 mg / vial )
`
`100.0 mg / vial
`
`We herewith confirm that this batch was manufactured and tested in accordance with the relevant
`GMP requirements.
`Status: Approved for clinical trials
`
`• Munich, May 21st, 2003
`
`Dr. Unterlinner
`Head of Product Release/QC
`
`Fuchs
`Product Documentation/QC
`
`Adminisirove headpuariers: (cid:9)
`Operations: (cid:9)
`Telephone:
`Berg•am•(aim•Slresse 129 (cid:9)
`Weihenelephaner Strasse 28 (cid:9)
`+49(0)89 45 44-01
`D-81673 Minoan (cid:9)
`0.81673 MOnchen
`V.A.T.No:
`Telefas: +4910189 45 44.13 29 7e1elax. +49(0)8945 44-15 95 OE 811188277 (cid:9)
`
`Dresdner Bank Munchen
`Stad1sparkasse Munchen
`into®lupsawa•deutschland.de acct. 1 0301782500
`acct. # 39-180039
`Websile:
`Bank 10 Code: 70080000 (cid:9)
`Bank ID Code: 701 50000
`wee.? uoisawederotschland.de SWIFT•addrese: ORES OE FF 700 SWIFT-address: SSKM DE MM A)0(
`
`Company Seal: MUnchen • incoroorsled al the Coen Reg eery in Munchen HR B 67 708 • President: Dr. Wolfgang litho( • Executive Voce Resident OiplAtm. Wolfgang Schoch
`Executive Drieclors: 0.p1.•K(m. Molten Fischer - Or. Erich Kammell • Or. File Sian,slaus
`
`CEPHALON, INC. -- EXHIBIT 2028 0002
`
`(cid:9)
`(cid:9)
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