Tablet Dissolution Test in Different Stages (S1, S2 and S3) : Pharmaceutical Guidelines

Tablet Dissolution Test in Different Stages (S1, S2 and S3)

Learn about the dissolution stages followed during the failure of the sample using the six dosage form units.
Dissolution test is done to verify the release of drug in the solution from the tablet because binders, granulation, mixing and coating may affect the release of drug from tablets.

The amount of dissolved active ingredient is known as Q in dissolution test. The limit of Q may be different in different monographs according to the nature of the formulation and its active ingredients. Dissolution test is done using 6 units or dosage forms

Dissolution Test
These dosages forms are run for the specified time period, sampled and analyzed for the dissolved amount of active ingredient in percentage. This is the first stage of the dissolution and known as S1 Stage.

In S1 stage dissolved amount of each unit should not be less than Q+5%. It shows that every unit should be above the 5% of the specified limit in the individual monograph. If any of the units is found below this limit then we have to analyze the sample in the S2 stage.


Six additional units are also tested for the dissolved content. Now the average of the all 12 units should not be less than Q and no unit should be less than Q-15%. It gives some flexibility to the test results. Average should be equal to or more than Q but some units may below the Q. If any unit is found below the Q-15 or average of all units is less than Q then the sample is analyzed in the S3 stage.

Twelve more units are also analyzed for the dissolved active content. At this stage the average of all 24 units should not be less than Q, only two units may below the Q-15% and no unit should be less than Q-25%. This stage gives more flexibility to the sample because the average of 24 units should be equal to or more than Q but two units may up to Q-25.

Dissolution stages give the flexibility to the sample that is unable to pass the dissolution test. These stages are accepted by all regulatory bodies. Hence, it is a widely accepted test method for the dissolution of solid dosage forms.



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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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16 comments: Post Yours! Read Comment Policy ▼

  1. Dear Sir,

    These articles were very informative.

    I am very much thankful to you.

    Regards
    Mohan

    ReplyDelete
  2. Nicely explained.. dissolution criteria thanks sir..

    ReplyDelete
  3. pls...give information for sustain release....

    ReplyDelete
  4. Thanks for providing useful information. Helpful for learners. Keep posting of similar posts.

    ReplyDelete
  5. Why should we use only 2mm or #10 mesh in dissolution basket...?? is there any guideline??

    ReplyDelete
    Replies
    1. Yes, it is given in pharmacopoeia.

      Delete
  6. Why we use only 6 apertures in baskets or 6 dosage units in dissolution tests...?? Why can't we take more than 6 if we take it's better to provide the reproducibility of the system...Does it make sense??

    ReplyDelete
    Replies
    1. Pharmacopoeia says to take 6 tablets for dissolution.

      Delete
  7. This comment has been removed by the author.

    ReplyDelete
  8. How to calculate Q ? It's depend on formulation & different products. Any example & calculation.

    ReplyDelete
  9. good and very informative but this guideline applicable in product development stage?

    ReplyDelete
  10. good and very informative but this guideline applicable in product development stage?

    ReplyDelete
  11. This guideline is applicable in product development stage?

    ReplyDelete
  12. If 6 tablets in S1 stage shows Q less than 25% the. Is it necessarg to carry the test to S3 or not ?

    ReplyDelete


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