Method development

[brbabu_1979]

Hi every one,
I am new to this forum. I have some quries about impurity method developments. How we are going to determine the concentration of final test sample for imputiy analysis? Is there any special resons to determine the concentration. Is there any scientific resons or any calculations. Please give me the details,

Thanks in advance

Babu

[ATL Chrom]

Babu,

My name is Andy Johansen and I am a Sr. Product Specialist with Sorbent Technologies. Please contact me directly so i can help with your questions. Have a great day.

[brbabu_1979]

Hi Andy Johansen ,
Thank you for your replay. I am not getting your
e-mail ID to contact you please provide me.

Thanks
Babu

[ATL Chrom]

ajohansen@sorbtech.com

[Alera]

Hey Babu, it really depends on your application. For most pharmaceutical methods, typical requirement is to have LOQ for all impurities of not higher than 0.1% of the active compound. Based on this, the concentration of your sample for impurity analysis will be 1000xLOQ of your method.

I hope this helps.

[scottythree]

I'm not sure if you are in a regulated pharma lab but you may want to check ICH guidelines Q2, Q3's, Q6's, Q8 for some methodology/specifications.

http://www.ich.org

[krickos]

I'm not sure if you are in a regulated pharma lab but you may want to check ICH guidelines Q2, Q3's, Q6's, Q8 for some methodology/specifications.

http://www.ich.org

Agreed.

Also if you in the pharma buisnees you might have to consider the PGI (potential gentoxic impurities) guidelines availble at FDAs and EMAs (former EMEA) websites. Here we talk low ppm levels (0,01-0,0001%) rather than the typical 0,01-0,05% levels of impurities.