Dear all,
Can anybody help me how to perform BET of ceftriaxone Sodium.Accordintg to our validation our non interference dilution is 8 and the safety factor is 32.
the given EL is 2.0IU/ml and concentration is 10mg/ml
Dear all,
Can anybody help me how to perform BET of ceftriaxone Sodium.Accordintg to our validation our non interference dilution is 8 and the safety factor is 32.
the given EL is 2.0IU/ml and concentration is 10mg/ml
Dear Your Question is How to perform the BET of Cef. (10 mg / ml)
MVD : Maximum Valid Dilution
NID: Non Interfering Dilution
EL : Endotoxin Limit
So For testing your dilution (Validation is MVD / 8)
So First MVD = EL x PP / Lyste Sensetivity
MVD: 2 x 10 / 0.125 = 160 MVD
SO MVD / 8 = 160 / 8 = 20
MVD/8 = 20 you have to dilute your product maximum upto 20 times for MVD / 8.
Dilution :
10 mg / ml (1 ml )
↓
2 ml (1 ml Product + 1 ml LRW)
↓
2 ml (0.2 ml A + 1.8 ml) For testing.
Put the test and if no gel formation is there release the product : Less than 1 EU / mg.
If any problem is there please contact on : sojitra_pankaj2003@yahoo.com
Or M:09979842207.