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News: ½ð±Ò+2, ¡ï¡ï¡ïºÜÓаïÖú, ÎÒÃÇÂòµÄÊǺ¬Á¿¶ÔÕÕÆ·£¬²»ÊÇÔÓÖʶÔÕÕÆ·£¬ÄãÌṩµÄ×ÊÁÏÀïÃæÃ»ÓÐÌá¼°ÎÒÓöµ½µÄÎÊÌâ¡£²»ÖªµÀ£¬Ä㻹ÓÐʲô×ÊÁϿɹ©²Î¿¼£¿Ð»Ð» 2013-04-17 15:23:14
zhychen2008: ½ð±Ò+2, ¸Ðл»ØÌû½»Á÷ 2013-04-17 23:46:17
http://www.edqm.eu/en/EDQM-FAQ-a ... 0.html?rubrique=468

01. How can I find out the purity of a Ph. Eur. CRS?

The assigned content of a CRS is given in the online search catalogue and on the CRS label, when it is required to calculate the content using the prescribed test and/or assay of a prevailing European Pharmacopoeia monograph.

In other cases, values are not assigned and it cannot be assumed that the purity is 100%. However, the purity of an impurity CRS, can be assumed to be 100% for the test for related substances of the prevailing European Pharmacopoeia monograph, if the purity is not indicated. The assigned content of lyophilised preparations may be expressed as mass of pure substance per vial (eg mg/vial) or potency per vial (eg IU units/vial).
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