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Oral liquids are homogeneous liquid preparations, usually a solution, an emulsion or a suspension of one or more active ingredients in a suitable liquid base. They are prepared for oral administration as such or after dilution. They may contain other substances such as suitable dispersing, solubilizing, wetting, emulsifying, stabilizing, suspending, thickening agents and antimicrobial substances for preservation.
They may contain suitable sweetening agents, flavoring agents and approved coloring agents. If sodium saccharin or potassium saccharin is used for sweetening, its concentration in infant preparations should not exceed 5 mg per kg of body weight.
During the oral fluid manufacturing, packaging, storage and distribution process, microbial quality should be maintained and microbial counts should be within acceptance criteria.
Oral fluids should not be diluted and stored after dilution unless the individual monograph directs dilution. The reconstituted oral liquid may not be physically and chemically stable for long periods of time so it should be freshly diluted or used within the time stated on the label.
