5. REFERENCES USED FOR THE Q4B EVALUATION

5.1 The PDG Stage 5B sign-off document ( Rev .5.2.2 Japanese Pharmacopoeia ( JP ) : 6.09 Disintegration Test as it appeared in the partial revision of the JP 15th edition made official March 31 , 2009 , by the Ministry of Health Labour and Welfare Ministerial Notification No . 190 .Disintegration issued June 6 , 2008 , and officia August 1 , 2008 .