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Pharmaceuticals QC Testing

Pharmaceutical Equivalence Study

Pharmaceutical equivalence study

Complying with MFDS Guideline

SLS Bio will carry out pharmaceutical equivalence study(comparative dissolution/comparative disintegration).

Comparative dissolution test As one of the pharmaceutical equivalence studies, this test refers to the one in Chapter 3 of the 「Standard on Pharmaceutical Equivalence Study」.

Dissolution tests shall be tested under the validated conditions according to this notification or more than equal, and each reference product and test product shall be tested on not less than 12 samples under each test condition. However, in case it is deemed that a test on each of the test medias is unnecessary due to the characteristics of the active substance, then the scientific ground (e.g., literatures or books on the physicochemical properties, etc.) or preliminary test results (on at least 6 samples) shall be attached to the test results report for submission.

Comparative disintegration testAs one of the pharmaceutical equivalence studies, this test refers to the one in Chapter 4 of the 「Standard on Pharmaceutical Equivalence Study」.

For 12 vessels of each reference and test drugs (for suppository 6 vessels), perform disintegration test in accordance with specification and test method of reference drug or disintegration test method in the Korean Pharmacopoeia, and record the number of disintegrated vessels an interval of 5 min, and conduct the test until all the test and reference drugs are disintegrated.

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