Functional Category
Organic base.
Applications in Pharmaceutical Formulation
Meglumine is an organic base used as a pH-adjusting agent and solubilizing agent, primarily in the preparation of soluble salts of iodinated organic acids used as X-ray contrast media.
Description
Meglumine occurs as a white to slightly yellow-colored crystalline powder; it is odorless or with a slight odor.
Stability and Storage Conditions
Meglumine does not polymerize or dehydrate unless heated above 1508C for prolonged periods. The bulk material should be stored in a well-closed container in a cool, dry place. Meglumine should not be stored in aluminum containers since it reacts to evolve hydrogen gas; it discolors if stored in containers made from copper or copper alloys. Stainless steel containers are recommended.
Incompatibilities
Incompatible with aluminum, copper, mineral acids, and oxidizing materials. Differential scanning calorimetry studies suggest meglumine is incompatible with glipizide.(1)
Safety
Meglumine is widely used in parenteral pharmaceutical formulations and is generally regarded as a nontoxic material at the levels usually employed as an excipient. LD50 (mouse, IP): 1.68 g/kg