Product Details
                    
                                            
                            
                                Category
                            
                            
                                Preservatives; Humectants; Solvents                            
                         
                                            
                            
                                Molecular Formula
                            
                            
                                C4H10O2                            
                         
                                            
                                            
                            
                                Grade
                            
                            
                                Pharmceutical Excipients                            
                         
                                            
                            
                                Description
                            
                            
                                Butylene glycol occurs as a clear, colorless, viscous liquid with a sweet flavor and bitter aftertaste.                            
                         
                                            
                                            
                            
                                Chemical Name
                            
                            
                                1,3-Butanediol                            
                         
                                            
                                            
                            
                                Synonyms
                            
                            
                                Butane-1,3-diol; 1,3-butylene glycol; b-butylene glycol; 1,3-dihy- droxybutane; methyltrimethylene glycol.                            
                         
                                            
                            
                                Dosage Form
                            
                            
                                Transdermal patches;topical gel patches/medicated plasters                            
                         
                                            
                            
                                Stability and Storage Conditions
                            
                            
                                Butylene glycol is hygroscopic and should be stored in a well-closed container in a cool, dry, well-ventilated place. When heated to decomposition, butylene glycol emits acrid smoke and irritating fumes.                            
                         
                                            
                            
                                Source and Preparation
                            
                            
                                Butylene glycol is prepared by catalytic hydrogenation of aldol using Raney nickel.                            
                         
                                            
                            
                                Applications
                            
                            
                                Butylene glycol is used as a solvent and cosolvent for injectables.It is used in topical ointments, creams, and lotions,and it is also used as a vehicle in transdermal patches. Butylene glycol is a good solvent for many pharmaceuticals, especially estrogenic substances.In an oil-in-water emulsion, butylene glycol exerts its best antimicrobial effects at 8% concentration.Higher concentrations above 16.7% are required to inhibit fungal growth.                            
                         
                                            
                            
                                Safety
                            
                            
                                Butylene glycol is used in a wide variety of cosmetic formulations and is generally regarded as a relatively nontoxic material. It ismildly toxic by oral and subcutaneous routes. In topical preparations, butylene glycol is regarded as minimally irritant. Butylene glycol can cause allergic contact dermatitis, with local sensitivity reported in patch tests. Some local irritation is produced on eye contact. LD50 (guinea pig, oral): 11.0 g/kg; LD50 (mouse, oral): 12.98 g/kg; LD50 (rat, oral): 18.61 g/kg; LD50 (rat, SC): 20.0 g/kg                            
                         
                                            
                            
                                Incompatibilities
                            
                            
                                Butylene glycol is incompatible with oxidizing reagents.