CERTIFICATE OF ANALYSIS

Product : Heparin Sodium bovine origin P! Eur!

"atc no! : #RAFT #ate o$ production : %&'(%)(

Product*no! : #RAFT #ate o$ e+pir, : %-'(%)&
Page : ) ' )
Contro./ Speci$ication Re/u.t/
Appearance white, hygroscopic powder,
watersoluble
complies
Identification:
a) anti clotting activity
b) sodium
c) H-RM !"#$#)
a) it delays the clotting of frishly
shed blood
b) complies
c) complies
complies
complies
complies
I% H&'$ complies complies
Anticlotting activity !(&) as is ) *++ I,-,.mg */0 I,-,1mg
Appearance of the solution $lear solution and complies color
2+
complies
'oss on drying 3 4 5 0 5
pH !*5 solution) +,+ 6 4,7 1,*
A0/7 nm #olution 7,8 5 3 7,*+ 7,78 5
&rotein !'owery methode) 3 7,+ 5 7,0 5
itrogen *,+ 6 0,+ 5 0,7 5
Heavy metals 3 97 ppm : 97 ppm
#odium ;,+ 6 *0,+ 5 **,1 5
(lectrophoretic impurities complies complies
<otal plate count 3 *77 $=-.g : *7 $=-.g
>acterial-(ndoto?ins .0,/,*8 3 7,7* I,-,(ndoto?in per I,-,
Heparin activity
: 7,7* I,-,.I,-,
0RAE"ER 1 CO 23"H #ATE:
4ua.it, Contro.
HRB 8248 PI, Amtsgericht Pinneberg USt-IdNr./VAT-No.: DE 118304875 St.-Nr.: 18/291/17305
Geschftsfhrer: Jens-Uwe Kraeber, Franziska Faber, Anja Kuhnert