What are the types of dissolution test?
Currently, there are seven different types of dissolution apparatus defined in the United States Pharmacopeia (USP)-basket type, paddle type, reciprocating cylinder, flow through cell, paddle over disc, rotating cylinder, and reciprocating disc.
What is USP dissolution test?
A dissolution experiment evaluates the rate and extent that a compound forms a solution under carefully controlled conditions. The dissolution test in a USP drug product monograph helps evaluate the performance of a drug product (article) and indicates when the drug product performs in a substandard fashion.
How is the dissolution test done?
A dissolution test uses an apparatus with specific test conditions in combination with acceptance criteria to evaluate the performance of the product. General chapter <711> Dissolution includes 4 standardized apparatus: basket, paddle, reciprocating cylinder, and flow-through cell.
Why is 900mL dissolution media?
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. On the low end, why 500mL?
What is Q value in dissolution?
Q, is the amount of dissolved active ingredient ✦specified in. the individual monograph✦, expressed as a percentage of. Proceed as described for Delayed-Release Dosage Forms, the labeled content of the dosage unit; the 5%, 15%, and. Method B under Apparatus 1 and Apparatus 2 using one row.
What is S1 S2 S3 in dissolution?
In stage S3, another 12 units are to be analyzed, the average of 24 units (S1+S2+S3) should be equal to or more than Q and no unit is less than Q-25% and not more than 2 units are less than Q-15%. In this S3 dissolution stage, 3 units are acceptable below Q, which gives more flexibility.
What is Q value for dissolution?
Answer: Q represents the targeted amount of active substance, expressed as a percentage of the label claim, which should be dissolved within a certain time. The ‘Q value’ should be seen as a “reference value” to which the dissolution results are compared.
What is RSD in dissolution?
Dissolution results may be considered highly variable if the relative standard deviation (RSD) is greater than 20% at time points of 10 minutes or less and greater than 10% RSD at later time points.
Why are 6 units used in 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 f1 and f2 in dissolution?
The fit factors can be expressed by two approaches: f1 (the difference factor) and f2 (the similarity factor). Two dissolution profiles to be considered similar and bioequivalent, f1 should be between 0 and 15 whereas f2 should be between 50 and 1006.
What is S1 and S2 in dissolution?
The dissolved amount of each unit in S1 stage should not be less than Q+5%. It shows that each product should exceed 5% of the dissolved amount specified in the individual Manograph. If any of the units falls below the limit, then we have to reanalyse the sample in the next stage. i.e. S2 stage.
What is CDP in dissolution?
Comparative Dissolution Profile (CDP) between Generic Product and Comparator Product with Gastro-Resistance Formulation As agre.
What is D value in dissolution?
The value of D in Table 4 is 75 percent dissolved unless otherwise specified. The quantity, D, is the specified total amount of active substance dissolved in both the acid and buffer stages, expressed as a percentage of the labeled content.
What is F value in dissolution?
Statistical methods
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.
Why do we use 6 tablets for dissolution?
What is S1 S2 in dissolution?
S1 or S2. The quantity, Q is the amount of dissolved active. Dissolution Medium—Proceed as directed for Immediate- ingredient. specified in the individual monograph, expressed Release Dosage Forms under Apparatus 1 and Apparatus 2.