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This is a query in relation to Mr. Frederic's answer. Can anyone give
us the reference to acceptable guidelines (regulatory or otherwise)
regarding impurity levels of API and formulation (drug product) to be
used for efficacy and toxicity studies?
As Frederic says, "... concn does not vary more than 5% ....check that
no major impurity appears...", we are interested to know what
percentage of impuritiesshould we call acceptablein the formulation
'ab initio' and on storage - if it is to be used for preclinical
efficacy and/or toxicity studies.
Regards
S. Pramanick
Torrent Research Centre, Ahmedabad, India
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This is a query in relation to Mr. Frederic's answer. Can anyone give
us the reference to acceptable guidelines (regulatory or otherwise)
regarding impurity levels of API and formulation (drug product) to be
used for efficacy and toxicity studies?
As Frederic says, "... concn does not vary more than 5% ....check that
no major impurity appears...", we are interested to know what
percentage of impuritiesshould we call acceptablein the formulation
'ab initio' and on storage - if it is to be used for preclinical
efficacy and/or toxicity studies.
Regards
S. Pramanick
Torrent Research Centre, Ahmedabad, India
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The following message was posted to: PharmPK
Our standard acceptance range is normally ±10% for dosing
solutions/suspensions used in tox. studies. However, depending on the
vehicle/carrier (i.e., feed admix, difficult suspensions, etc.)it may be
necessary to increase that range.
Philip
Philip A. Downing
Manager, Analytical Services
BASi Evansville
(812)985-3400, ext. 125
(812)955-3403 (fax)
www.bastox.com
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The following message was posted to: PharmPK
Your range is more or less 10% but you have to identify the impurities
and
to ensure that they don't interfere in tox effects, don't you.
Regards,
Frédéric DOC
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