Chromatography Forum

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.

I'm not a cGMP expert, but do have a lot of experience in the OTC pharmaceutical business. Typically, our protocols and validations call for linearity to be 80 to 120% of target, with at least five real data points.

You have established a linearity range that should cover 80 to 120% for each. I would suggest just documenting that.

I'm nota cGMP expert, but do have a lot of experience in the OTC pharmaceutical business. Typically, our protocols and validations call for linearity to be 80 to 120% of target, with at least five real data points.

You have established a linearity range that should cover 80 to 120% for each. I would suggest just documenting that.

can you explain further your info? thanks

can you explain further your info? thanks

We had a product that contained about 64% alcohol, validated test procedure. Then we added a product of 70% alcohol, wanted to use the same procedure (not wanting to decrease the sample size by 10% of the higher level product). So we extended our linearity curve upwards to cover 120% of the higher level product when sampled at the highest allowable amount in the test procedure, then did our precsion/accuracy, etc on the new product.