ARTICLE
TITLE

Results convergence of pharmacopoeial tests by titrimetric methods: acceptance criteria and experimental parameter

SUMMARY

Quality assurance of test results is one of the topical issues of analytical laboratories functioning. Scientifically reasonable criteria and recommendations in relation to the scheme and quality control of pharmacopoeial tests results by volumetric titration methods were developed by the authors according to the previous studies results. The criteria were elaborated by results of test uncertainty estimation.Conclusion. The acceptability criteria developed on scientific reasoning basis meet the main parameter of titrimetric methods tests and can be recommended for the use in- functioning of pharmaceutical analytical laboratories

 Articles related

Alla Glushchenko,Ivan Bezruk,Nataliia Bevz,Liudas Ivanauskas,Victoriya Georgiyants    

Nowadays, combined medicines are becoming more and more widespread. The combination of active pharmaceutical ingredients is necessary to increase the therapeutic effect or shorten the treatment period, or prevent possible complications. The aim of the wo... see more


?. ?. ????????    

Validation studies of cromoglicate sodium assay at eye drops with antiallergic action?. G.  FetisovaNationalUniversityofPharmacy,KharkovIntroduction. Today during pharmaceutical development of drugs as well as at the all stage of product lifecycle, ... see more


S. V. Misiurova,V. Ye. Dobrova,N. O. Svid,I. A. Otrishko    

One of the stages in development and implementation of the quality system in medical laboratories is to conduct the validation works. The main objects of these works are the methods by which measurements of various parameters inthe laboratory are ca... see more


Maki Matsuhama ,Tomoko Takishita ,Ryosuke Kuribayashi ,Kazunori Takagi ,Rika Wakao ,Kenichi Mikami    

Purpose. A gap analysis survey of international practices for Active Substance Master Files (ASMFs)/Drug Master Files (DMFs) of human use was conducted as a project of the ASMF/DMF working group of the International Generic Drug Regulators Pilot (IGDRP) ... see more


Joy Elizabeth van Oudtshoorn ,Alfredo García-Arieta ,Gustavo Mendes Lima Santos ,Christopher Crane ,Clare Rodrigues ,Craig Simon ,Ji Myoung Kim ,Sang Aeh Park ,Yusuke Okada ,Ryosuke Kuribayashi ,Chantal Pfäffli ,Arno Nolting ,Iván Omar Calderón Lojero ,Zulema Rodríguez Martínez ,Wen-Yi Hung ,April C. Braddy ,Nancy Arciniegas Leal ,Diego Gutierrez Triana ,Mitch Clarke ,Peter Bachmann    

Purpose:  The Biopharmaceutics Classification System (BCS) based biowaiver is a scientific model which enables the substitution of in vivo bioequivalence studies with in vitro data as evidence of therapeutic equivalence subject to certain conditions. Des... see more