Description
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0.9% Sodium Chloride Injection, USP solution is sterile and nonpyrogenic. It is a parenteral solution containing sodium chloride in water for injection intended for intravenous administration. For 0.9% sodium Chloride Injection, USP, each 100 ml contains 900 mg sodium chloride in water for injection. Electrolytes per 1,000ml: sodium 154 mEq; chloride 154 mEq. The osmolarity is 308 mOsmol/l (calc.). The pH in the 100 ml and smaller containers is 6.0; for the 250 ml and larger containers, the pH is 5.6. The pH range is 4.5 to 7.0 for all containers. The solution contains no bacteriostatic, antimicrobial agent, or added buffer and is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. The solution is a parenteral fluid and electrolyte replenisher. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for injection, USP is chemically designated H20. The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (freef/e bag).The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container’s chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers