Apr 2, 2009 ... Reference standards can be compendial or noncompendial and are typically obtained from the following sources. Compendial (primary):.
Primary Reference Standard (example). • JLR (CaHbNcOd .HCl.H2O) ..... Miscellaneous Issues. • Qualification of Non-Ph. Eur. primary reference standards .
Feb 8, 2012 ... Members of USP Council of Experts and USP Reference Standards Committee .... Qualification of one national primary reference material by ...
May 5, 2017 ... In API manufacturing, reference standards can help ensure identity, ... Resolution —used to determine assay performance or impurity method qualification. ... as Primary Reference Standard, or a highly characterized in-house ...
Part A. Primary chemical reference substances. A.1 Assessment of need for the establishment of chemical reference substances. A.2 Obtaining source material.
Mar 1, 2014 ... It should be noted that the term primary reference standard used here is distinct ... to the qualification protocol, and primary reference standards.
Convenient and cost-effective alternative to primary reference standards, with ... in advance of any COA changes that may occur due to re-qualification etc.
Jul 25, 2013 ... 11.17 Primary reference standards should be obtained as appropriate for the manufacture of APIs The source of each primary reference ...
Primary Standards: Primary reference standards should have a purity of 99.5 percent ... Primary standard qualification requires extensive characteriza- tion and ...
Storage, Usage, Disposal of Reference Standards and Qualification, Numbering, Packing, Storage, Usage and Disposal of Working Standards.