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PROCESS FOR THE PREPARATION OF NON-GENOTOXIC DIACETYLRHEIN (DIACEREIN) AND FORMULATIONS COMPRISING NON-GENOTOXIC DIACETYLRHEIN
PROCESS FOR THE PREPARATION OF NON-GENOTOXIC DIACETYLRHEIN (DIACEREIN) AND FORMULATIONS COMPRISING NON-GENOTOXIC DIACETYLRHEIN
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机译:非基因型双乙酰胆碱(diacerein)的制备方法及包含非基因型双乙酰胆碱的制剂
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摘要
The present invention is directed to a process for producing non-genotoxic Diacetylrhein (Diacerein), comprising: i) transformation of raw Diacerein (or raw Rhein), into a water-soluble sa ii) adsorption of the salt Diacerein (or Rhein) solution on a hydrophobic resin; iii) washing with an appropriate solvent to eliminate the impurities (in particular the genotoxic impurities); iv) elution to recover Diacereinor Rhein; v) if the process is applied to Rhein, its transformation to Diacerein by acetylation; vi) acidification of purified Diacerein and its recovery, and drying. The invention is also directed to non-genotoxic Diacerein obtained by the process of the invention, in which the total content of genotoxic impurities is below 1 ppm, and suitable for the preparation of pharmaceutical formulations, in particular capsules, for human and veterinary use, in agreement with the current Health Authorities request.
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