Hello All,
My name is humayun , i am newly log in in this site, basically i am a laboratory chemist,i have faced some problem regarding calculation of mg/swab after analysis on hplc, if you have a formula for calculation of mg/swab kindly help me.
Thanks
Humayun
Analyst:rolleyes:
mg/swab=Area spl/Area std x Std Conc. (mg/ml) x sample volume (ml) /%recovery for the surface.
thanks bob
Dear
The molecules under manufacturing are having similar solubility property in water. Hence the worst case is determined from solubility data. Maximum Allowable Residue (MAR) for any combination of products during changeover in the subsequent product will be calculated by considering the smallest batch size, and highest weight of the tablets and maximum daily dose.
Using obtained Maximum Allowable Residue, acceptance limit mcg / swab will be calculated according to the equipment surface area. Subsequently the final allowable acceptance limit will be calculated for sampled surface area of individual equipment.
Himansu K
Validation Sr. Executive