To Establish a Criterion for Dissolution by Variables and Comparison with Criteria by Attributes

JING Xiong-ping;FU Xio-ying;WEI Li-ping;JIN Shou-dong

Chinese Pharmaceutical Journal ›› 2009, Vol. 44 ›› Issue (23) : 1825-1829.

PDF(3124 KB)
PDF(3124 KB)
Chinese Pharmaceutical Journal ›› 2009, Vol. 44 ›› Issue (23) : 1825-1829.
Article

To Establish a Criterion for Dissolution by Variables and Comparison with Criteria by Attributes

  • JIANG Xiong-ping1 , FU Xiao-ying2 , WEI Li-ping1 , JIN Shou-dong1
Author information +
History +

Abstract

OBJECTIVE To establish a criterion for dissolution by variables. METHODS To derive the criterion formula A=|M-D|+α/(e|M-D|×b+1)+kS by using probability theory and Statistics,and to compare between criteria by variables and by attributes. RESULTS The criterion by variables was the strictest one. The second was the criterion of Ch.P(2005). The third was the criterion of USP32. The repeat test rates from low to high were Ch.P(2005),Criterion by variables and USP32 respectively. The sample contents were 6.43,7.82-7.98,11.60 for Ch.P(2005),Criterion by variables and USP32. CONCLUSION The criterion by variables could control the uniformity of dissolution,and was stricter than criteria by attributes.

Key words

dissolution / uniformity

Cite this article

Download Citations
JING Xiong-ping;FU Xio-ying;WEI Li-ping;JIN Shou-dong . To Establish a Criterion for Dissolution by Variables and Comparison with Criteria by Attributes[J]. Chinese Pharmaceutical Journal, 2009, 44(23): 1825-1829

References


[1] <>Ch.P(2005) Vol II (中国药典 2005 年版 . 二部)[ S ] .2005: Appendix 73.
[2] USP32.2008[S].General Chapters:711.
[3] XIN H H. <>Sampling Test Technologies (抽样检验技术) [M]. Beijing : China Metrology Publishing House, 2005.9.
( 收稿日期 : 2009-06-18 )

PDF(3124 KB)

Accesses

Citation

Detail

Sections
Recommended

/