512712015
`
`Technical Quality Dextran I Pharmacosmos Dextran
`
`Technical Quality Dextran
`
`Technical Quality Dextran is a high purity dextran fraction with selected average molecular weight and
`molecular weight distribution.
`
`Easily soluble Pharmacosmos Technical Quality Dextran fractions are used as starting or intermediate
`reagents in several different processes in biotech, photographic and chemical manufacturing industries.
`
`• Dextran Tl
`
`• Dextran Tl.5
`
`• Dextran T3.5
`
`• Dextran T5
`
`• Dextran T6
`
`• Dextran TIO
`
`• Dextran T20
`
`• Dextran T25
`
`• Dextran T40
`
`• Dextran T60
`
`• Dextran TIO
`
`• Dextran TllO
`
`• Dextran T150
`
`• Dextran T250
`
`• Dextran T500
`
`• Dextran T750
`
`• Dextran T2000
`
`Suggested reading
`
`htlp:/.lwww .dextran.netJproductsltechnical-quaJ ity/c-24/c-74
`
`1J2
`
`Pharmacosmos, Exh. 1023, p. 1
`
`
`
`Technical Quality Dextran I Pharmacosmos Dextran
`
`Technical Quality Dextran
`
`Technical Quality Dextran is a high purity dextran fraction with selected average molecular weight and
`molecular weight distribution.
`
`Easily soluble Pharmacosmos Technical Quality Dextran fractions are used as starting or intermediate
`reagents in several different processes in biotech, photographic and chemical manufacturing industries.
`
`• Dextran Tl
`
`• Dextran Tl.5
`
`• Dextran T3.5
`
`• Dextran T5
`
`• Dextran T6
`
`• Dextran TIO
`
`• Dextran T20
`
`• Dextran T25
`
`• Dextran T40
`
`• Dextran T60
`
`• Dextran TIO
`
`• Dextran TllO
`
`• Dextran T150
`
`• Dextran T250
`
`• Dextran T500
`
`• Dextran T750
`
`• Dextran T2000
`
`Suggested reading
`
`htlp:/.lwww .dextran.netJproductsltechnical-quaJ ity/c-24/c-74
`
`1J2
`
`Pharmacosmos, Exh. 1023, p. 1
`
`
`
`512712015
`
`Technical Quality Dextran I Pharmacosmos Dextran
`
`htlp:/.lwww .dextran.netJproductsltechnical-quaJ ity/c-24/c-74
`
`212
`
`Pharmacosmos, Exh. 1023, p. 2
`
`
`
`llDl,.,T1~~IA•11 1mDmran
`
`Dextran Tl Technical Quality
`
`DcxtranTl
`
`Tec:hnlcal Quality Delctran T1 Is a high pglty du!J111 fraction with selected IN'8lllg8 m~ .... welgtt and""*"' ....
`weight dllltrlbutlon.
`
`l l
`
`Oextran 1
`
`... ~h).$)f&
`
`l>iAAtio;Oim1
`•oet\1 ~~1~
`
`• pgqamc;ptatjgn
`• Ifcm mo j; Pw;Jrafdnl
`• tzac of Pcrvtran
`
`If you require a delctran prodllCt mnllctlnd ecconttng to Good MftlacUI~ Prdce (GMP), we reccnwnelld
`Pillnnlcolmol' Pbtann•inl Q•e!itv PM'D·
`
`Download Ba cllon
`
`BRCI>eg!ranTl
`Budi Rdea&e Cediticatc I Dcxll&11 l
`GMP Actiye SUMmw ttmmm I Ap:il 2014
`
`MBPS on ns1•1uPowder
`
`Pharmacosmos, Exh. 1023, p. 3
`
`
`
`512712015
`Safety Data Sheet
`
`Dextran T1 Technical Quality I Pharmacosmos Dextran
`
`Technical Quality Dextrans from Pharmacosmos are packed and stored in safe and clean conditions.
`
`Technical Quality Dextran T1 is available in the following pack sizes:
`
`Item no
`
`Weight Packaging
`
`5510 0001 9006 100 g. Polyethylene container, FDA registered, DMF type Ill.
`
`5510 0001 9007 500 g. Polyethylene container, FDA registered, DMF type Ill.
`
`5510 0001 9001 5 kg.
`
`Polypropylene container. Dextran powder sealed in double polyethylene bags
`
`5510 0001 9005 50 kg. Fiber drum with the dextran powder sealed in double polyethylene bags.
`
`Pharmacosmos supplies Technical Quality Dextrans to all countries. The product packing meets all national and
`international regulations.
`
`Technical Quality Dextran fractions are used as starting or intermediate reagents in several different processes in biotech,
`photographic and chemical manufacturing industries.
`
`Suggested reading
`
`htlp:/.lwww.dextran.netJproductsJdextran-t1/r;,.24/p-250
`
`212
`
`Pharmacosmos, Exh. 1023, p. 4
`
`
`
`Valid from: HSA/LC 10-12-2012
`Replaces: HSA/LC 01-10-2012
`
`Product name:
`
`Dextran T1
`
`Specification No.:
`Batch No.:
`
`40036
`ABxxx
`
`Manufacturing sites:
`DKMA* No.:
`GMP certificate No.:
`FDA establishment No.:
`FDA facility classification:
`EDQM* certificate No.:
`
`Pharmacosmos A/S, Roervangsvej 30, DK-4300 Holbaek, Denmark
`254629
`N/A
`N/A
`N/A
`N/A
`
`Method:
`
`Parameter:
`
`Results of analysis:
`
`
`
`Limits:
`
`
`
`LI030-1
`DF001
`DF030
`
`DF005
`DF009
`DF012
`DF019
`
`Description:
`Average molecular mass, Mw:
`Loss on drying (105°C, 5h), % w/w:
`Color of solution (Absorbance at 375
`nm, 6% sol., 1 cm):
`Acidity or Alkalinity:
`Specific rotation (+/-) °:
`Heavy metals, ppm lead:
`Nitrogen containing impurities, ppm N:
`
`Complies
`xx,100
`x.x
`x.xx
`
`Complies
`+x.x
`x
`x
`
` White Powder
`
`Complies
`
`*) EDQM refers to 'European Directorate for the Quality of Medicines and healthcare'. DKMA refers to 'Danish Medicines Agency'.
`We hereby confirm that no class 1, class 2 and class 3 solvent, cf. ICH Q3C and VICH GL 18, is used in the manufacturing of this product.
`
`I hereby certify that the above information is authentic and accurate. This batch has been manufactured, including packaging and quality control in
`full compliance with the above mentioned specifications. NOTE: This product is not manufactured according to Good Manufacturing Practice (GMP).
`
`Date (dd.mm.yyyy):
`
`Hans Juhl, M.Sc., Quality Control
`
`Page 1 of 1
`
`Pharmacosmos, Exh. 1023, p. 5
`
`
`
`512712015
`
`Pharmaceutical Quality Dextran I Pharmacosmos Dextran
`
`Pharmaceutical Quality Dextran
`
`When Dextran is used in a Pharmaceutical Product or Medical Device, a Pharmaceutical Quality of
`Dextran should be applied.
`
`All Pharmaceutical Quality Dextran manufactured by Pharmacosmos meets the quality standards of the
`Pharmacopoeia products Dextran 1, 40, 60, and 70. In all other aspects than molecular weight it is of the
`same chemical and biological purity and with specification limits analogous with the Pharmacopoeia!
`products.
`
`• Dextran 1
`
`• Dextran 1.5
`
`• Dextran 3.5
`
`• Dextran 5
`
`• Dextran 10
`
`• Dextran20
`
`• Dextran25
`
`• Dextran40
`
`• Dextran 60
`
`• Dextran 70
`
`• Dextran 110
`
`• Dextran 150
`
`• Dextran 250
`
`• Dextran 500
`
`• Dextran 750
`
`Suggested reading
`
`htlp:/.lwww.dextran.netJproducts/pharmaceutical-quality/c-241c-70
`
`1/1
`
`Pharmacosmos, Exh. 1023, p. 6
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