The dissolution test results for a particular product have a high variability and are very high. What is the upper limit for the amount of drug released in dissolution testing?
100% drug release except in case of having overage in your label amount.
Correct. The release naturally cannot be higher than 100% of the total drug content. What is important is the lower limit, not the upper limit, in most of the cases.
Dear Vipul, When asking a question to fora in general (RG included) one should describe/include the rational or justification for asking the question so fellow researchers may get the framework. In addition, the helpful and valid feedbacks should be acknowledged by recommending the contributions. Unfortunately RG removed the "down vote" for wrong and/or absurd contributions made by people that just wanted to increase hits.
As such, would you be so kind to let us know what kind of answer you were expecting other that 100% (assuming no analytical inaccuracy) and why?
I should say that there are several/lots of cases were it is not 100% but before disclosing any details I first need to understand your question. And BTW sometimes what really matters is the upper limit (although this is not the most common case).
Regards, Luis
As per dissolution guideline / ICH limit is 85 to 115 %of label claim. Go through the guideline
@Vipul, Would you be so kind to clarify what do you actually want to know (please take a look to my previous post)?
@Md R Khayer. Would you be so kind to let us know to which "dissolution guideline" are you referring to? And where is the 85-115% drug dissolved (wrt label claim) requirement stated?
I mean in dissolution testing with repetion of dissolution trial (atleat 10 times), I am getting average 113% dissolution. So it is accepted or not? I cant able to disclose drug molecule and dosage form as I will try to make patent on formulation.
Dear Vipul,
I am afraid but either you have an analytical problem or a manufacturing problem! This is not a question of what is the acceptable limit but WHY are you getting these values.
If you manufacture your dosage form to have a strength of, for example, 100 mg of API/tablet, how come you end up with 113 mg?
What is the assay value (using 20 tablets, for example)? Do you weight the tablets prior to dissolution to ensure the excessive value is not due to tablet overweight?
What analytical method and sample prep are you using? Is the drug stable in the dissolution medium (light, pH, etc).