# Linearity Curve

we have two different strenghts of tablets for our disso test. The first one has a standard conc of 0.02mg/ml and the other has 0.025mg/ml. We then made a 0.027mg/ml as our 100% concentration for the linearity curve, the range we used is between 40% to 140%. Can we just say that the linearity curve we established is just okay for the two standard concentrations i mentioned early? This is as per our validation requirement. Thanks.

Do I understand this correctly, a 100 % release would give a concentration of 0.027 mg/ml?

You are preparing two standard solutions 0.02 and 0.025 mg/ml, are you using both of these solutions to calculate the results and establishing a correlation between the two to provide evidence of correct standard preparation?

If so, this is acceptable, but I would recommend your standard concentrations bracket the 100 % release concentration, for example 0.02 and 0.03 mg/ml.

Please feel free to PM me if I can be of further assistance.

Kind regards

[quote=David1]Do I understand this correctly, a 100 % release would give a concentration of 0.027 mg/ml?

You are preparing two standard solutions 0.02 and 0.025 mg/ml, are you using both of these solutions to calculate the results and establishing a correlation between the two to provide evidence of correct standard preparation?

If so, this is acceptable, but I would recommend your standard concentrations bracket the 100 % release concentration, for example 0.02 and 0.03 mg/ml.

Please feel free to PM me if I can be of further assistance.

Kind regards

[/quote]

the 100% release concentration is actually 0.022mg/ml for 100mg tablet and 0.028mg/ml for 50mg tablet. So with those concentrations, can I just simply use the 0.027mg/ml concentration as 100% concentration for my linearity curve? Thanks.

I think its ok as long as your validation range covers all possible concentrations of dissolution samples.