Dear All,
If content uniformity is to measure by weight variation then what should be the specification of weight variation for Hard gelatin capsule (The label claim is 500mg)? What could be the alert and action limit? I have gone through BP and it says if it is a capsule of label claim 300mg or more then 7.5% weight variation is allowed.
Where as in USP it says if 2-3 unit is outside the range of 85-115% of the label claim and no unit is outside the range of 75-125% of the label claim or if the RSD is greater than 6% or both condition prevail then test 20 additional units. The requirements are met if not more than 3 of the 30 units are outside the range of 85-115% of the label claim and no units are outside the range of 75-125% of the label claim and RSD of 30 units does not exceeds 7.8 then the product is acceptable.
According to USP is it okay to keep a in-process specification of weight variation at 12% as alert limit and 15% as action limit?
USP has a very wide range then BP. Why this is so? My product is a BP product so which specification i should follow?
I will be very happy and grateful if anyone explain me the whole issue in detail.
Thanks
Zahid