Limit of Chloroacetic acid in API [June 14, 2004]
Posted: Tue Aug 24, 2004 9:46 pm
By huang on Monday, June 14, 2004 - 06:16 am:
Hello everyone:I will determine the Chloroacetic acid which is residue solvent in API,Could you tell me the limit of Chloroacetic acid? Thanks of all.
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By Anonymous on Monday, June 14, 2004 - 01:06 pm:
Choroacetic acid ( I guess you mean mono-) isn't listed into the ICH/EP/USP/ residual solvents lists.
EPA has calculated a provisional Reference Dose (RfD) of 0.002 milligrams per kilogram body weight per day (mg/kg/d) for chloroacetic acid. The RfD is an estimate (with uncertainty spanning perhaps an order of magnitude) of a daily oral exposure to the human population (including sensitive subgroups) that is likely to be without appreciable risk of deleterious noncancer effects during a lifetime. It is not a direct estimator of risk but rather a reference point to gauge the potential effects. At exposures increasingly greater than the RfD, the potential for adverse health effects increases. Lifetime exposure above the RfD does not imply that an adverse health effect would necessarily occur.
Now, caclulate the daily therapeutic dose of your API and estimate the maximum residual concentration for chloroacetic acid.
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By Anonymous on Monday, June 14, 2004 - 06:07 pm:
What is API? Please explain...
Sorry, I am new... :p
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By huang on Monday, June 14, 2004 - 06:37 pm:
API means active pharmaceutical ingredient
Hello everyone:I will determine the Chloroacetic acid which is residue solvent in API,Could you tell me the limit of Chloroacetic acid? Thanks of all.
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By Anonymous on Monday, June 14, 2004 - 01:06 pm:
Choroacetic acid ( I guess you mean mono-) isn't listed into the ICH/EP/USP/ residual solvents lists.
EPA has calculated a provisional Reference Dose (RfD) of 0.002 milligrams per kilogram body weight per day (mg/kg/d) for chloroacetic acid. The RfD is an estimate (with uncertainty spanning perhaps an order of magnitude) of a daily oral exposure to the human population (including sensitive subgroups) that is likely to be without appreciable risk of deleterious noncancer effects during a lifetime. It is not a direct estimator of risk but rather a reference point to gauge the potential effects. At exposures increasingly greater than the RfD, the potential for adverse health effects increases. Lifetime exposure above the RfD does not imply that an adverse health effect would necessarily occur.
Now, caclulate the daily therapeutic dose of your API and estimate the maximum residual concentration for chloroacetic acid.
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By Anonymous on Monday, June 14, 2004 - 06:07 pm:
What is API? Please explain...
Sorry, I am new... :p
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By huang on Monday, June 14, 2004 - 06:37 pm:
API means active pharmaceutical ingredient