Publication of the amendment of the Executive Order for Danske Medicinal Products 2008.2
§ 1
Notice no. 633 of 28. In May 2008 on Danish Medicines Products 2008.2, the following changes are made :
1. I § 1 is replaced by "1-7" to : "1-8".
2. the following Annex 7 is added as Appendix 8 :
' Annex 8-SPECIFICATIONS FOR OVERSULPHATEATED CHONDROCHITINSULPHAT IN HEPARINCALCIUM AND HEPARINNATRIUM.
The characteristics of the medicinal product type shall be the absence of the excess of the chondroitinsulphat of the chondroitinsula, by the use of the NMRI and the CE methods.
Analytical details for methods can be found via the FDA's home page : www.fda.gov/cder/drug/infopage/heparin/default.htm#screening.
Note that the FDA's website no longer contains detailed descriptions of the methods, but a link to the USP where methods are described in detail in the revised monograph of the Heparin Sodium.
From the USP, a Heparin Sodium System Suitability Reference Standard can be requested by the USP and contains the chondroitinsulphat containing the excess sulphate.
In the NMR method, USP calls for the use of 500 MHz. The use of 300 MHz, as required by Ph. Eur. The monographers are acceptable. "
§ 2
The announcement shall enter into force on 1. September 2008.
The medical board, the 18-18. August 2008 Jytte Lyngvig/Anne-Marie Vangsted
