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The document discusses a proposed transform in the coating approach for Dapakan 500mg film coated tablets from a solvent coating to an aqueous coating. It describes altering from coating with Opadry OIC 7000 to coating with Opadry II.Regulatory audits are done by bodies such as FDA to make sure compliance with Good Production Procedures (GMP). The

Check materials spiked at lower degrees with representative organisms (including the aerobic bacterium Staphylococcus aureus, spore forming bacterium Bacillus subtilis, anaerobic bacterium Clostridium sporogenes or perhaps the fungus Candida albicans) are employed to guarantee there isn't a inhibitory result with the sample which can mask contamina

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