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.