Dissolution Testing - Requirements of the Chinese Pharmacopoeia
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For many pharmaceutical companies, the importance of the Chinese market keeps on increasing. Therefore, knowing the regulatory requirements in China is essential.
In the Chinese "Pharmacopoeia of the People's Republic of China" - 9th edition (2010, English Version, ChP) you can find the provisions on dissolution testing.
Unfortunately, the dissolution method described in the ChP isn't completely harmonised with the USP, Ph. Eur or the Japanese Pharmacopeia (JP). Compared to the USP for example, there are significant differences in:
- the size of the basket: 36.8 mm ± 3.0 mm (ChP) vs. 37.0 ± 3.0 mm (USP)
- the width of the paddle: 74.0 mm ± 5.0 mm (ChP) vs. 74.0 - 75.0 mm (USP)
- and also in the size of the container (vessel) for standard basket and paddle: 1000 mL only (ChP) vs. 1 or 2 or 4 L (USP)
There are also differences in the evaluation of the dissolution testings compared to the harmonised methods (Ph.Eur., USP, JP) like for example:
- Diffferent stages ("staging approach") in the ChP
- Differences in the interpretation of the "Q" term for certain dosage forms
- Not more than 12 samples can be investigated.
PS: The ECA Course "Dissolution Testing" from 16-18 June 2014 in Berlin, Germany will present a comparison of the different requirements from all the pharmacopeias.
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