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. 1038, 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. 1038, p. 1
`
`
`
`512712015
`
`Technical Quality Dextran I Pharmacosmos Dextran
`
`htlp:/.lwww .dextran.netJproductsltechnical-quaJ ity/c-24/c-74
`
`212
`
`Pharmacosmos, Exh. 1038, 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. 1038, 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. 1038, 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. 1038, 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. 1038, p. 6
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
