I had a query for one of the tests. We received from one of our partners Clindamycin Injection 150mg/ml for BET testing. The LImit in Indian pharmacopoeia is stated as 6 EU/ml.
As per the Pharmacopoeia we have to dilute the Injection with LRW to obtain solution of 10mg/ml prior to testing. So substituting that in equation for MVD we obtain the value of 480 as MVD (sensitivity of lysate is 0.125 Eu/ml)
However the vendor uses the potency of product as 1ml/ml and hence MVD for them is 48.
Can you please clarify which is the correct way for testing this product.
HI,
As i know in pharmacopoeia the limit is mentioned as 0.58EU/mg
However, as you mentioned in IP its mentioned as 6EU/ml for the con 10mg/ml
Below is the calculation :
0.58EU/mg x10mg/ml = 5.8EU/ml
So it is mandatory to perform according to the concentration (w/v%)
But, I don’t know about your vendor’s specification can you please send me the vendors Endotoxin limit and the concentration of the sample .
then i could explain you more about this
So, To conclude both are same .
Since in the IP it is mentioned as 6EU/ml for 10 mg /ml which gives MVD value as 48 .
Same applies for your vendor as well 6EU/ml for 1ml/ml which gives MVD value as 48.