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low HPLC assay results

Posted: Tue Nov 01, 2011 9:15 am
by gys25016
recently I did a HPLC assay for drug substance, the result is 95%w/w after correction of water and solvent.
As is result is about 90%, water is about 4.47%w/w and solvent is about 0. Ash is 0.38%w/w. impurity is about 0.7%w/w.

The calucation and precision are quite good. Just wonder what are the posible things for the rest of 5% in the material and normally how to identify them.

Thank you guys!

Re: low HPLC assay results

Posted: Tue Nov 08, 2011 1:55 pm
by max_planck
recently I did a HPLC assay for drug substance, the result is 95%w/w after correction of water and solvent.
As is result is about 90%, water is about 4.47%w/w and solvent is about 0. Ash is 0.38%w/w. impurity is about 0.7%w/w.

The calucation and precision are quite good. Just wonder what are the posible things for the rest of 5% in the material and normally how to identify them.

Thank you guys!
Did you include standard purity in the calculation?