SPL Set ID: 19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e
1 drug(s) with this SPL Set ID
Physiolyte is a sterile, nonpyrogenic solution of electrolytes in water for injection intended only for sterile irrigation, washing, and rinsing purposes. Each 100 mL contains: Sodium Chloride USP 0.53 g; Sodium Gluconate USP 0.5 g Sodium Acetate Trihydrate USP 0.37 g; Potassium Chloride USP 0.037 g; Magnesium Chloride Hexahydrate USP 0.03 g Water for Injection USP qs Glacial Acetic Acid USP has been added to adjust the pH pH: 6.8 (6.3–7.3) Calculated Osmolarity: The solution is isotonic (295 mOsmol/liter) Concentration of Electrolytes (mEq/liter): Sodium 140 Potassium 5; Magnesium 3; Chloride 98; Acetate (CH 3 COO − ) 27 Gluconate (HOCH 2 (CHOH) 4 COO − ) 23 It contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose or short procedure irrigation. When smaller volumes are required the unused portion should be discarded. Physiolyte may be classified as a sterile irrigant, wash, rinse and pharmaceutical vehicle. The formulas of the active ingredients are: Ingredients Molecular Formula Molecular Weight Sodium Chloride USP NaCl 58.44 Sodium Acetate Trihydrate USP CH 3 COONa•3H 2 O 136.08 Potassium Chloride USP KCl 74.55 Magnesium Chloride Hexahydrate USP MgCl 2 •6H 2 O 203.30 Sodium Gluconate USP 218.14 The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class VI testing as specified in the U.S. Pharmacopeia for Biological Tests. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. Not made with natural rubber latex, PVC or DEHP. Chemical Structure