BET Validation!

GOOD VALIDATION PRACTICE (cGVP) LABORATORY, METHOD AND ANALYTICAL VALIDATION
1

Dear Forum,

Some queires on BET method Validation

  1. Why should we dilute product at MVD/32 when we validate our product ?
    Can we dilute more than that if yes ? what is justification ?

  2. During method validation the final concentration of endotoxin ia always
    kept 0.25 EU/mL ?

Regards,

Ravindra Sonawane
+919975252560

2

HELLO

  1. During validation study of BET you should perform test on different sets of sample i.e. Directly, Dilutions half to MVD, Dilution near MVD and at MVD. it will give give you the good picture that upto how much extant your product inhibit or enhance the reation.
  2. It is not necessary that u should use 0.25 Endotoxin control. most commonly the 0.125 sensitivity lysate is use to test BACTERIAL ENDOTOXINS and for positive control it is recommended that u should use twice concentration of standard than lysate i.e. 2 lamda thats why 0.25 Eu is use for test most commonly
3

I have a question about you’re statement regarding the dilutions.
Do you have to perform such a dilution series during the validation? We routinely dilute our samples to 1:50 and 1:100 and the ppc recovery are fine. The MVD for our sample is 1:350,000 so I feel that actually diluting it that low would be meaningless.
What do you think?

4

can anybody explain me about BET Method validation in detail,