EP 2034 药用物质(中英文)04/2013:2034 EP 7.5 SUBSTANCES FOR PHARMACEUTICAL USE 药用物质 DEFINITION定义 Substances for pharmaceutical use are any organic or inorganic substances that are used as active substances or excipient
EP2034药用物质(中英文).pdf,2034E 药用物质 04/2013:2034 EP 7.5 SUBSTANCES FOR PHARMACEUTICAL USE 药用物质 DEFINITION 定义 Substances for pharmaceutical use are any organic or inorganic substances that are used as active substances or excipients for the pr
2034E 药用物质 04/2013:2034 EP 7.5 SUBSTANCES FOR PHARMACEUTICAL USE 药用物质 DEFINITION 定义 Substances for pharmaceutical use are any organic or inorganic substances that are used as active substances or excipients for the production of medicinal products for human or veterinary use. They may be...
2034E 药用物质 第 1 页共 9 页 04/2013:2034 EP 7.5 SUBSTANCES FOR PHARMACEUTICAL USE 药用物质 DEFINITION 定义 Substances for pharmaceutical use are any organic or inorganic substances that are used as active substances or excipients for the production of medicinal products for human or veterinary ...
Substances for pharmaceutical useEUROPEAN PHARMACOPOEIA 7.007/2009:2034SUBSTANCESFOR PHARMACEUTICAL USECorpora ad usum pharmaceuticumDEFINITIONSubstances for pharmaceutical use are any organic or inorganicsubstances that are used as active substances or excipients forthe production of medicinal products for human...
EP药用物质(中英文).doc,04/2013:2034 EP 7.5 SUBSTANCES FOR PHARMACEUTICAL USE 药用物质 DEFINITION 定义 Substances for pharmaceutical use are any organic or inorganic substances that are used as active substances or excipients for the production of medicin
2023年6月20日至21日欧洲药典委员会(EPC)举办第176次会议时,审查了其现行的方法,并考虑了有关N-亚硝胺杂质方面的现有文件,尤其是Substances for pharmaceutical use(2034)和Pharmaceutical preparations(2619),两个通则现在均包含了相应声明(见最近发布的11.3增补版)。本次会议中决定对原料药和制剂各论中N-亚硝胺...
use(2034).Itisthereforenotnecessarytoidentifythese impuritiesfordemonstrationofcompliance.Seealso5.10. Controlofimpuritiesinsubstancesforpharmaceuticaluse): –galantaminefromnaturalsources:B, –galantamineproducedbyasyntheticprocess:A,B,E. A.(4aS,8aS)-3-methoxy-11-methyl-4a,5,9,10,11,12- ...
with the general monograph on Substances for pharmaceutical use (2034), Related substances section....
monographSubstancesforpharmaceuticaluse(2034), notablythoseconcerningthresholds,donotapplyto excipients;alsoexcludedfromtheprovisionsofthissection are:biologicalandbiotechnologicalproducts;oligonucleotides; radiopharmaceuticals;fermentationproductsandsemisynthetic productsderivedtherefrom;herbalproductsandcrudeproducts ...