Impurity reference standard

GOOD VALIDATION PRACTICE (cGVP) LABORATORY, METHOD AND ANALYTICAL VALIDATION
1

dear all,

Any idea about the allowable impurities(residual solvents etc.,) level prescribed for Impurity Reference Standards to be used for validation.:slight_smile:

thanks in advance

PatilSK

2

Hi Shanmkhpatil

Labcompliance specialise in this type of validation you may find the following white paper very useful.

http://www.labcompliance.com/documents/LH/referencepapers/a-603-method-validation.pdf

Hope this helps

3

Thanks Mr.Graham for the paper…however I am looking for the “allowable impurity limit” prescribed by the ICH or any regulatory body in the reference standard to be used for validation

Thanks once again

Patilsk:)