Content uniformity testing equipment:

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Degree of uniformity of the API present within the dosage
units is termed as Uniformity of dosage unit or content uniformity.

It governs the process control of disperse systems and also
the product stability.

Various factors effecting content uniformity are particle
size, blending, mixing, homogenizing, holding, filling etc..,

It is used to conclude or decide that every tablet contains
the amount of API intended with little variation within a batch among all the
tablets.

As per USP, procedures used to determine content uniformity
testing are as follows:

Stage1 Criteria:

Ten tablets are can taken and assay is performed.

And if

  • RSD
    i.e. relative standard deviation is less than 6.0% ( <6.0% ) and
  • No
    value is out of the limit 85-115%

Then the batch is said to be passed for the content
uniformity test. If the above case is not satisfies then stage2 acceptance
criteria has to done.

Suppose one or more values fall outside 75-125% then the
batch is said to be failed.

Stage2 criteria:

Here 20 tablets more are taken and then assay is performed.
Stage1 and stage2 together make 30 tablets totally.

And if

  • RSD is
    less than 8.5% (<8.5%) and
  • Not
    more than one value is out of 85-115% of claim or no value is out of
    75-125% of the claim

Then the batch is said to be pass. If not then whole batch
is declared to be failed.

Content uniformity test not required for

  • Multi-vitamin
    tablets
  • Trace
    element preparations and
  • Other
    justified cases

According to B.P:

Content uniformity test can be classified into three types
based on the type of dosage forms. They are:

  • Test A
  • Test B
  • Test C

Test A:

Dosage forms which come under this test are:

In this procedure stage1 and stage2 criteria are followed.

Test B:

Various dosage forms which come under this are:

  • Suppositories
  • Pessaries
  • Powders other than for parenteral use
  • Granules

Test C:

This Content uniformity test is
performed to transdermal patches.

Dosage form is said to be pass if

  • The
    average content of the ten dosage units is within 90-110% and
  • Individual
    content of each dosage unit is within 75 to 125% of average content.

Several assay procedures have been
designed to proceed on with content uniformity testing. HPLC, GC, various assay
procedures such as Bicinchonic Acid Assay, performance verification test have
been developed.

'This blog doesn't contain plagiarised material" 5,6

References:

1). Pharmaceutical dosage forms: disperse
systems by Herbert A. Lieberman, Martin M. Rieger, Gilbert S. banker. {Pg.no-
504-510}[Accessed on 17/07/2010]

2).British pharmacopoeia,
2009[accessed on 17/07/2010]

3). Indian pharmacopoeia,
1996[accessed on 18/07/2010]

4).

http://www.usp.org/pdf/EN/meetings/asMeetingIndia2009/session1Track2Williams.pdf

[Accessed on 17/07/2010]

5).http://www.dustball.com/cs/plagiarism.checker/

Results: No plagiarism
suspected

6).http://www.articlechecker.com/checker.php

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About the Author

Shanthi Priya's picture
Author: Shanthi Priya

Comments

Uma Pratyusha's picture

Hi Shantipriya, Can you please tell me why multivitamin tablets do not undergo content uniformity test?

Regards

Uma Prathyusha

kranthi kumar's picture

Dear Shantipriya, This is simple and good. Hope to see a pictures.

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