FORCED DEGRADATION:
ICH: a2R1) VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY
ANVISA: CoLLEGIATE BOARD RESOLUTION – RDC No. 53, OF DECEMBER 4, 2015
Topic: metal ion catalysed oxidation
ICH
NOT required
ANVISA
Required analysis cu 2+, Fe 3+(accelerate, oxidative reaction)
Topic:Degradation
ICH
NOT clarify provided
ANVISA
Greater than 10 %
Topic :FD for non chromatography &performance method
ICH
No clarity provided
ANVISA
executed
-Resolution of collegiate board RDC#166 of July 24,2017
Liniarity
ICH
No of liniarity solution
Minimum 5 concentration solution required
ANVISA
5 different concentration of CRS
Must be used for solution prepared.
Least triplicate
2.Evolution parameters
ICH
The correction coefficient, y intercept, slop of the regression line and residual sum of square should be submitted
ANVISA
Dispersion of the residual, coefficient of correction (r) and the determination (r2), angular coefficient, Homemoscedasticity,
Limit
ICH
No detail provided
ANVISA
The correction of coefficient should be above 0.990
The angular coefficient shall be significant different from zero.