Dear sir
First of all Thank you for helping me and send me a brief reply of my thead, sir i have an ther confusion in your articale which i am pasting here,

for HPLC analysis the formula is given as:


Amount of residue detected = (PA1 / PA2) x {(W x P) / VS)}

Where, PA1 = Peak area of sample, PA2 = Peak Area of Standard, W = Weight of standard, P = Potency of standard (in %) and VS = Total Volume of solvent used for making the standard solution.

Compare the “Amount of residue detected” with the analytical limit. If “Amount of residue detected” < analytical limit then the result would be Pass i.e. the amount of residue in CV sample is below the acceptance limit.[/B]sir my question in this article is that,how can i calculate analytical limits, is it is
10ppm?

thanks
Humayun

Assalam u alikum
Mr OVAIS
Basically i am a laboratory chemist , im totally confuse in cleaning validation calculation after run samples on hplc, may i use this samples area in my calculation, please help me
Humayun

Dear Ovais,

fantastic Spread sheet which i got from u. it has cleared my 80% of my qeries only one query left out, that is how to prepare a matrix if we have a 20 to 25 products in a facility of oral dosage?? what should be the criteria & caluculation steps to be followed???


Thank u very much,
BRAVI.
APOTEX