The DELFLEX® peritoneal dialysis solutions (standard and low magnesium/ low calcium) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. These solutions do not contain antimicrobial agents or additional buffers. Composition, calculated osmolarity, pH, and ionic concentrations are shown in
Dextrose, USP, is chemically designated D-glucose monohydrate (C
2O) a hexose sugar freely soluble in water. The structural formula is shown here:
Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl
2O) white fragments or granules freely soluble in water.
Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl
2O) colorless flakes or crystals very soluble in water.
Sodium lactate solution, USP, is chemically designated (CH
3CH(OH)COONa), a 60% aqueous solution miscible in water.
Sodium chloride, USP, is chemically designated (NaCl), a white, crystalline compound freely soluble in water.
Water for injection, USP, is chemically designated (H
Hydrochloric Acid or Sodium Hydroxide may be added for pH adjustment. pH is 5.5 ± 0.5.
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. Since the inner bag is compounded from flexible plastic, water may permeate from the inner bag into the overwrap in quantities insufficient to affect the solution significantly. Solutions in contact with the plastic inner bag can cause certain chemical components of the bag to leach out in very small amounts; however, the safety of the plastic formulation is supported by biological tests for plastic containers.