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Emulsification: Slowly incorporate the heated aqueous phase into the melted stearic acid with continuous stirring. Keep on mixing right until the emulsion is fashioned.➢ Dry Granulation Method: In this process, the API and excipients are compacted to variety slugs or ribbons, which might be then milled into granules. These granules are compressed
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No. 21 CFR 211.113(a) requires suitable penned processes to get proven and followed through manufacturing to forestall objectionable microorganisms in drug solutions not needed to be sterile. Moreover, the next paragraph of USP Standard Chapter Antimicrobial Performance Tests reads: Antimicrobial preservatives shouldn't be utilised as an a