Hello Sir,
Your guidance is required regarding BET method validation of Amoxycillin (as trihydrate) 150mg/ml suspension for injection. ( Excipients is liquid parafilm For veterinary). Recommended dose is 15 mg/ml.
I have calculated the endotoxin limit as 0.333 (k=5/m=15). So Mvd=200 for 0.25 eu/ml lysate.
Lysate sensitivity results are within acceptance criteria.
For NID test, I made the product dilution at mvd/32, mvd/16, mvd/8, mvd/4,mvd/2 and tested. I got PPC positive results at mvd/2 only and negative at mvd/32, mvd/16, mvd/8, mvd/4.
Is the results are correct?.
Please suggest.