The revised national part to the General Text 5.12 "Reference Standards" has been included in Supplement 1 to the 2d Edition of the State Pharmacopoeia of Ukraine (SPhU).
The updated text provides an explanation of the compatibility of the terms used by the European Pharmacopoeia and SPhU as to reference standards. The status of SPhU RSs as official is explained. In routine tests, SPhU RSs can be used in place of official reference standards of the European Pharmacopeia. This is, primarily, of great importance to domestic manufacturers of medicinal herbs and medicinal herbal products since price issues may be crucial for them.
A user is provided with all necessary information for the correct use of SPhU RSs in non-pharmacopeial procedures as well as for the analysis of non-pharmacopoeial substances. This makes the use of SPhU RSs legitimate in such cases in contrast to the RSs of other pharmacopoeias which are rigidly tied to pharmacopeial monographs. Such use of SPhU RSs is particularly important for manufacturers of generic medicines as there are no other officially recognized reference standards. Information about the uncertainty of assigned value of SPhU RSs and clearly defined metrological approaches to certification and use of reference standards make it possible to control the risks of making an incorrect decision about quality of medicinal products. In addition, it enables users to certify working (secondary) reference standards for quantitative tests metrologically correctly. Note that the European Pharmacopoeia considers the use of reference standards of the European Pharmacopoeia incorrect for the certification of working reference standards (including impurity tests), since information about the uncertainty of assigned value is not provided for them.
Also, the new text clarifies the use of working reference standards. Information that is uninformative for users is excluded.
Information about authors and reviewers:
Elaborated at: Ukrainian Scientific Pharmacopoeial Centre for Quality of Medicines
Authors: Leontiev D. – Sc.D., Head of the Validation and Reference Standards Department
Volovyk N. – Ph.D., Deputy Head of the Validation and Reference Standards Department
Gryzodub O. – Sc.D., prof., Chief Scientific Officer of the Department of the State Pharmacopoeia of Ukraine, Research Development Advisor of the State Pharmacopoeia of Ukraine
Reviewers: Dmitrieva M. – Ph.D., Ukrainian Scientific Pharmacopoeial Centre for Quality of Medicines
Pidpruzhnikov Yu. – Sc.D., prof., National University of Pharmacy
Kotova E. – Ph.D., Ukrainian Scientific Pharmacopoeial Centre for Quality of Medicines
Sur S. – Sc.D., Arterium Corporation