The use of a two-way analysis of variance to compare the methods for the assay of anhydrous dibasic calcium phosphate in the European, Japanese and United States Pharmacopoeias.
Tri-PEC (IPEC-Americas, IPEC-Europe and JPEC) carried out a two-way analysis of variance (Round Robin testing) for the assay of Anhydrous Dibasic Calcium Phosphate (CaHPO4) at the request of the Pharmacopoeial Discussion Group (PDG). On the basis of the result obtained, the difference in the assay results for anhydrous CaHPO4 using the different methods of the 3 Pharmacopoeias was not significant, while the difference in the results for the 3 different batch samples tested by 3 different methods was significant (p < 0.05). On the basis of these results, the methods from the 3 Pharmacopoeias, did not give different results, and thus the methods themselves should be considered equivalent.
Miyamoto
H
H
Japanese Pharmaceutical Excipients Council (JPEC). miyamoto.hb@om.asahi-kasei.co.jp
Saisho
N
N
Kato
Y
Y
Moreton
C
C
de Jong
H J
HJ
Kijima
K
K
D000704:Analysis of Variance; D002130:Calcium Phosphates / Q000032:analysis*; D005060:Europe; D007564:Japan; D010602:Pharmacopoeias as Topic; D011786:Quality Control; D017186:Titrimetry; D014481:United States
D002130:Calcium Phosphates; C485829:calcium phosphate, dibasic, anhydrous