Page 1 of 1
HPLC acetaminophen tablets assay
Posted: Wed Aug 03, 2011 11:28 pm
by adeerre
in compliance with USP, is realy necessary make a calibration curve to quantify the samples of acetaminophen tablets? if it is necessary, what range of concentration is more adecuate for the curve, in relaton with the preparation standard of 0,01 mg/ml mentioned in USP method.
Thank in advance.
Re: HPLC acetaminophen tablets assay
Posted: Wed Aug 03, 2011 11:45 pm
by Consumer Products Guy
Not directed specifically to acetominophen, but once we establish linearity in a test method validation, there's no need to continually re-establish that each time.
You don't HAVE to use the USP procedures for your material; prove and validate equivalency and document it.
There's lots of stuff in the USP that is "interesting".....
Re: HPLC acetaminophen tablets assay
Posted: Thu Aug 04, 2011 1:38 am
by adeerre
ok, but if i use USP method and cuantify tablets with the formula , for example for acetaminophen "10000c(ru/rs)" using only one preparation standard, is necessary make a validation?i guess no because usp method is a validated method....
i need avoid the validation at this time, i'm begginer in this methods, do you understand me?
anyway the linearity of my standard curve resulted satisfactory in all determinate range
thanks you very much!