Hydrochloride and Hydrocortisone Otic Suspension

Ciprofloxacin hydrochloride and hydrocortisone otic suspension contains the synthetic broad spectrum antibacterial agent, ciprofloxacin hydrochloride, combined with the anti-inflammatory corticosteroid, hydrocortisone, in a preserved, nonsterile suspension for otic use. Each milliliter contains ciprofloxacin hydrochloride (equivalent to 2 mg 

Use well-passivated stainless steel vessels use only sodium vapor lamps or yellow light in the manufacturing area. Avoid forming foam during transfer of liquids. 

Charge approximately 1 L of item 12 in a suitable vessel and heat to 90° to 95°C and then cool to 20° to 25°C under a nitrogen environment, and hold for later use for premixing, rinsing, and final volume makeup. 

Add and mix item 5 while maintaining nitrogen blanket cover. Cool to 40° to 50°C. 

Add and mix item 6 and cool to 20° to 25°C. In a separate vessel, mix acetic acid, sodium chloride and sodium acetate trihydrate in about 

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