Publication about a change to notice on Danish Medicines Products 2008.2
I Notice No 633 of 28. May 2008 on Danske Medicines 2008.2 is amended as follows :
1. In § 1 is replaced "1-8".
2. After Appendix 7 is inserted as Annex 8 :
"Appendix 8-SPECIFICATIONS FOR OVERSULPHATERET CHONDROITINSULPHAT IN HEPARINCALCIUM AND HEPARINNATRIUM".
The specification of the medicinal product type is the absence of the excess of the chondroitinsulphat of the chondroitinsula, by the use of the NMR and the CE methods.
Analytical details for methods can be found through the FDA's home page : www.fda.gov/cder/drug/infopage/heparin/default.htm#screening.
Note that the FDA is no longer containing detailed descriptions of the methods, but a link to the USP where the methods are described in detail in the revised monograph for Heparin Sodium.
From USP, a Heparin Sodium System Suitability Reference Standard can be requested by the USP to obtain the chondroitinsulphat.
In the NMR method, USP calls for the use of 500 MHz. The use of 300 MHz, as required by Ph. Eur. The Monography is acceptable. "
The announcement will enter into force on 1. September 2008.
Medicines Management, 18. August 2008Jytte Lyngvig/Anne-Marie Vangsted