新版的肝素钠欧洲药典标准.pdf

PA/PH/Exp. 6/T (09) 42 ANP NO TE ON THE MONOGRAPH This monograph has been thoroughly revised further to the contamination events in 2008 to update and strengthen the quality standards for unfractionated heparin. The style and presentation have also been updated in line with the latest version of the Style guide. Definition : the minimum potency limit has been raised after an enquiry among European manufacturers in line with the quality of currently marketed heparin batches; only 1 grade of heparin has been kept as the present 2-tiered specification no longer reflects the situation in Europe. Production : the tests for nuclear magnetic resonance spectrometry (NMR) a nd capillary st electrophoresis previously introduced in the 1 -step revision applicable from 1 August 2008 have been deleted, as detailed tests are now provided under Identification and Tests ; statements have been added to emphasise the need for a reliable quality assurance system throughout production and, based on current practice among E uropean manufacturers, for confirming the identity of the source species as well as the absence of any material issued from other species likely to contaminate the drug s ubstance. This monograph is also revised to harmonise the information related to the source species for substances of human and animal origin and its presentation in monographs. The statement relative to the origin of the substance is moved under Definition accordingly and a paragraph is added regarding the health of the animals used for the preparation of heparin sodium. Identification : the tests for specific optical rotation (shown not to be discriminative enough) and zone electrophoresis have been replaced by the highly specific 1H-NMR and strong a nion-exchange liquid chromatography (SAX-HPLC) t ests; 1H-NMR has been selected for its ability not only to allow identification of heparin, b ut also to alert users to