Pharmaceutical Quality of Warfarin Sodium Tablets
A multinational postmarket comparative study
Syed Laik Ali and Johannes KrÃ¤mer* )
Zentrallaboratorium Deutscher Apotheker, Eschborn (Germany)
A multinational postmarket comparative study on pharmaceutical quality of warfarin sodium tablets was performed under the auspieces of the Section of Official Laboratories and Medicines Control Services (OLMCS) of FIP and in cooperation with 13 laboratories in different countries. Alltogether 38 warfarin sodium tablet formulations of the respective countries were investigated. The products were tested for identity, purity, content, uniformity of mass, disintegration and in vitro dissolution. Most products tested fulfilled the pharmacopoeial requirements for identity, purity and content (95-105%). The test medium for in vitro dissolution demonstrated hyperdiscriminatory properties. Even the same standard formulation tested by all laboratories for in vitro dissolution showed considerable variations of dissolution profiles.
Key words Pharmaceutical quality Â· Warfarin sodium, tablets
* ) Present address: Labor- und QualitÃ¤ts-Service GmbH (LQS), Eschborn (Germany).
pharmind 1999, Nr. 4, Seite 363