What is dissolution acceptance criteria?
The drug product dissolution acceptance criterion is based on the high solubility of the drug substance. For immediate release solid oral drug products containing a high solubility drug substance (as defined herein), the dissolution criterion is Q=80% in 30 minutes.
What is f1 and f2 factor in dissolution?
Factor f1 indicates the percentage difference (dissimilarity) between two dissolution profiles; f2 is the logarithm of the reciprocal square root transformation of the sum squared error. It indicates the average percentage of similarity between two dissolution profiles.
What are the dissolution parameters?
2. INTRODUCTI ON 3 DEFINATION : • • Dissolution rate may be defined as amount of drug substance that goes in the solution per unit time under standard conditions of liquid/solid interface, temperature and solvent composition.
How dissolution medium is selected?
The analytical target profile (ATP) and drug substance solubility are key factors in dissolution medium selection. The ATP should indicate the type of dosage form for which the test is being developed. Drug substance solubility should be characterized over the physiological range of pH values.
Why do we use 900 ml in dissolution apparatus?
Most likely, the volume was lowered to 900mL to account for volume displacement from the product and stirring shaft. This gives some wiggle room in the test, so that the vessel doesn’t spill over during the dissolution. At these volumes, you can achieve success with most products as well.
Why do we use 6 tablets for dissolution?
Six units are tested to provide the minimal statistical significance. *Mean & Standard deviation (SD)* of any in-process or finished product CQA represents *Accuracy & Precision* of any Statistically Contolled Stable Process or Method.
What is F value in dissolution?
The factor f2 measures the closeness between the two profiles. An average difference of 10% at all measured time points results in a f2 value of 50. FDA has set a public standard of f2 value between 50-100 to indicate similarity between two dissolution profiles.
What is f1 in dissolution?
The factor, f1, is the average % difference over all time points in the amount of test brand dissolved as compared to the reference brand. The f1 value is 0 when the test and the reference profiles are identical and increases proportionally with the dissimilarity between the two profiles.
How do you select rpm in dissolution?
The selection of RPM depends upon type of formulation, solubility characteristics of active substances and apparatus used for dissolution study. For capsules (both soft gel and hard gel), USP-I i. e. Basket apparatus is recommended, rotation speed for paddle shall be 50 to 75 RPM.
Why is 500 mL dissolution media?
At 500mL, there is ample volume to have media above the paddle or basket and preserve hydrodynamics in the vessel. At these volumes, you can achieve success with most products as well. This volume typically is low enough that you have adequate concentration to read the samples in an HPLC or UV.
What should be the volume of a liquid dissolution test?
Using the paddle or basket apparatus, the volume ofdissolution medium is normally 500-1000 ml. A stirringspeed of between 50 r/min and 100 r/min is normallychosen; it must not exceed 150 r/min. For the flow-through apparatus, the liquid flow rate isnormally set between 4 ml/min and 50 ml/min.
When do you stop a gelatin dissolution test?
A When there is evidence or presence of cross-linking in the gelatin during the dissolution test of gelatin capsules or gelatin-coated tablets, you should stop the test and run the test again with the dissolution medium containing the enzyme with new units (not previously tested).
What is the acceptance criterion for Stage 1?
At stage 1 (S1), the acceptance criterion is going to be Q + 5%. Using the acceptance criterion included in your question, the acceptance criterion at S1 will be NLT 85% of the product label claim plus 5%. The acceptance criteria in the dissolution procedure remains NLT 85% (Q).
What are the acceptance criteria for batch release?
A If the acceptance criteria for this particular product is NLT 85% (Q), for batch release purposes the results are going to be evaluated using the Acceptance Table 1 in the USP general chapter <711> Dissolution. This table has three stages, and the product does not meet the acceptance criteria if it fails the three stages.