Validation study of related substances method

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

Dear All,
I have a validation study for related subtances, and I haven’t understand the following:
In a limit test method, some characteristics are not normally evaluated (Linearity, accuracy, precision,LOQ, range), But in in a quantitative method this characteristics are normally evaluated. Can you help me to understand the difference between Limit & Qualitative.

My method provides the area% of the impurity (with one impurity knowed) present in the sample compared to an 0,1% of API std (official limit).

Hope somebody can help me.

Best regards,

2

It must be quantitative as per ICH Q2R, otherwise you cannot control and set specifications for your Related Substances at release and expiry.

3

many thanks gokeeffe for your help.

Just to understand can you explain me the difference between Limit & Qualitative method for related subtances.

Best regards,

4

Dear Sir,

Please use our LinkedIn group to post this questions to Bruce:
[URL=“http://www.linkedin.com/groupAnswers?viewQuestionAndAnswers=&discussionID=109540844&gid=124639&commentID=77579264&trk=view_disc&ut=3-hdMtC_HTwRc1”]http://www.linkedin.com/groupAnswers?viewQuestionAndAnswers=&discussionID=109540844&gid=124639&commentID=77579264&trk=view_disc&ut=3-hdMtC_HTwRc1

[/url]Thank you