EXHIBIT 2030
`
`EXHIBIT 2030
`
`
`
`

`
`Fujisawa Deutschland GmbH
`
`CERTIFICATE OF ANALYSIS
`Bendamustin 100 mg for injection, Batch no. 03H07
`Expiry Date: 08.2005
`TI no.: 3.0
`
`Test parameter
`
`General characteristics
`
`Appearance
`
`Average mass
`
`Uniformity of mass
`
`Solubility
`
`Clarity after reconstitution
`
`Colour after reconstitution
`
`pH-value after reconstitution
`
`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
`Sterility
`Endotoxins
`Assay
`Bendamustine hydrochloride
`
`Specification
`
`Result
`
`white, microcrystalline lyophilisate
`
`198.0 - 242.0 mg
`
`complies with Ph. Eur. 2.9.5
`
`soluble within 5 minutes without
`residues
`
`clear
`
`s B 6
`
`2.5 - 3.5
`
`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
`
`complies
`
`222.3 mg
`
`complies
`
`complies
`
`complies
`
`complies
`
`3.2
`
`complies
`complies
`
`1.8 %
`n.d.
`<LOQ
`0.2 %
`n.d.
`n.d.
`0.3 %
`2.4 %
`1.9 %
`complies
`complies
`
`100.0 mg / vial
`(limits: 95.0 - 105.0 mg / vial )
`
`99.6 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, October 2nd, 2003
`
`; (cid:9)
`k.
`Dr. linterlinner
`Head of Product Release/QC
`
`Fuchs
`Product Documentation/QC
`
`Administrative headquarters:
`Beep-arn-larn-Strasse 129
`0-81673 Miinchen
`Teledbx: +19t0189 4544.1329
`
`Dresdner Bank Mencnen (cid:9)
`Stadlsparkasse Munchen
`iErlimat10.1114: isawil•deutschland.cle acct. O 03 017 825 00
`acct o 39-180 039
`Websee' (cid:9)
`Bank ID Code: 70080000 (cid:9)
`Bank ID Code: 701 50000
`vAwr.haisavia-deutSchland.de SWIFT-address. DRES DE FF 700 SWIFT-address. SSKM DE MM AXX
`Company Seat: Mtincnen • incorporated at the Court Registry in Munchen HR El 67 708 • Pretudent: Or. WoHgang Tinhof • Execuhve Vice President: Oiel.•Klin Wolfgang Schoch
`Execuhee Directors: Dipt•Kfm. Norbert Fischer . Or. Erich Kammer' • Dr. Fritz SlanIslaus
`
`Operations:
`We,henslephanei SHasse 28
`0-81673 Wootton
`Telefax: +49(0)8945 44 .1595
`
`Telephone:
`+49(0)894544.01
`VAT. No: (cid:9)
`DE 811188277 (cid:9)
`
`CEPHALON, INC. -- EXHIBIT 2030 0001
`
`

`
`HISSEN Laboratories s.
`
`Rue de la PapyrOe 2-6
`B-1420 BRAINE L'ALLEUD
`324-386.12.11
`Tel : (cid:9)
`32-2-385.17.82
`Fax: (cid:9)
`
`SDX 105 FOR INJECTION
`
`BATCH : 03H07
`
`TEST PARAMETER
`
`TEST METHOD
`
`RELEASE SPECIFICATION
`
`RESULTS
`
`General and specific characteristics
`
`e
`
`Visual examination
`
`Uniformity of dosage units
`
`Constituted solution
`
`pH value after reconstitution
`
`Ideality
`
`Bendamustine hydrochloride
`
`Bendamustine hydrochloride
`
`USP <905>
`
`USP <1>
`
`USP <791>
`
`HPLC
`
`HPLC
`
`Water content
`
`%Related substances
`
`USP <921> method 1
`
`Max 2.5 %
`
`HPLC
`
`HP1
`
`HP2
`
`HP3
`
`NP1
`
`BM1 EE
`
`BM1 DIMER
`
`BM1 DCE
`
`HBI
`
`Not identified single peaks
`
`J-Sum of not identified peaks
`
`Sum of all secondary peaks
`
`Sterility
`
`Bacterial endotoxines
`
`Particulate matter
`
`4
`
`USP <71>
`
`USP <85>
`
`USP <788>
`
`Max 33 %
`
`Max 0.5 °A)
`
`Max 0.1
`
`Max 0.5 %
`
`Max 0.6 6/0
`
`Max 0.7 6/0
`
`Max 0.1 6/0
`
`Max 0.5 %
`
`Max 0.1
`
`Max 0.5 %
`
`Max 5.0
`
`Sterile
`
`Max 0.5 I.U.
`
`lies
`
`0-)
`Michel HUME
`Quality Director
`ResOonsible Pharmacist
`
`White, microcrystalline
`lyophilisate
`Complies
`
`Complies
`
`2.5 - 3.5
`
`Complies
`
`Complies
`
`Complies
`
`3.2
`
`lies with standard
`
`Complies
`
`100.0 mg / vial
`
`95.0 — 105.0 mg/vial
`
`99.6
`
`1.9
`
`1.8
`
`ND
`
`ND
`
`< LOQ
`
`0.2
`
`0.3
`
`ND
`
`ND
`
`ND
`
`ND
`
`2.4
`
`Complies
`
`< 0.192
`
`Complies
`
`CEPHALON, INC. -- EXHIBIT 2030 0002