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Method development
Posted: Thu Sep 16, 2010 8:04 am
by 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
Posted: Thu Sep 16, 2010 3:16 pm
by 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.
Posted: Thu Sep 16, 2010 5:51 pm
by 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
Posted: Thu Sep 16, 2010 6:13 pm
by ATL Chrom
Posted: Thu Sep 16, 2010 6:31 pm
by 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.
Posted: Fri Sep 17, 2010 8:06 am
by 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
Posted: Fri Sep 17, 2010 3:12 pm
by 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.