SPL Set ID: ba7bf864-8a4d-4262-8fd1-00174fa2f9d1

Mannitol Injection, USP is a sterile, nonpyrogenic solution of mannitol in water for injection available in a concentration of 20% in flexible plastic containers. The content and characteristics of the available concentration is as follows: Concentration (%) g/100 mL mOsmol/liter (calc.) pH may contain sodium bicarbonate for pH adjustment. 20 20 1098 6.3 (4.5 to 7.0) The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. Mannitol Injection, USP is an osmotic diuretic for intravenous administration. Mannitol, USP is chemically designated D-mannitol (C 6 H 14 O 6 ), a white crystalline powder or free-flowing granules freely soluble in water. It has the following structural formula: Water for Injection, USP is chemically designated H 2 O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap, but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Chemical Structure