5. REFERENCES USED FOR THE Q4B EVALUATION

5.1 The PDG Stage 5B sign-off document : Japanese Pharmacopoeial Forum , Volume 13 , Number 3 ( August.5.2 The pharmacopoeial references for Particulate Matte for this annex are : 5.2.1 European Pharmacopoeia ( Ph . Eur . ) : 5th Edition ( official on January.The method was changed in September 2007 to correct a sentence in the introduction as underlined in the text that is provided by MHLW which is appended .