These standards include identity, strength, quality and purity of substances manufactured, distributed and consumed in the US. More details about these two USP General Chapters can be found in the online edition of the PF.The United States Pharmacopeia (USP) is a scientific, non-governmental organization which sets the official public standards for drugs and drug products in the US. The new USP requirements apply to all balances used for materials that must be "accurately weighed" (according to General Notices, 8.20).Īmong other things the repeatability requirement has been changed from 0.1% to 0.10% in order to reflect current metrology practices.Ī test weight should have a nominal mass between 5% and 100% of the balance's capacity.īoth the current USP requirements on Analytical Instrument Qualification and the concrete guidelines regarding handling and analytical instrument qualification will be important topics presented during ECA's Education Course " Analytical Instrument Qualification" from 20-22 February 2013 in Barcelona, Spain. In the future, the USP requirements on analytical balances will be slightly modified. Regarding the fundamental approach for qualification it is referred to USP Chapter on Analytical Instrument Qualification. Unlike General Chapter, Chapter isn't binding. It is planned to replace the title of General Chapter "Weights and Balances" by "Balances" and also to revise General Chapter "Weighing on an Analytical Balance".Ĭhapter provides background information and advice regarding the qualification of analytical balances - also in concrete terms for OQ and PQ including possible tests. In the Pharmacopeial Forum 38/5 two proposals have been published about the revision of the two General Chapters on analytical balances.
0 kommentar(er)
