Maximum Permissible Amount of Preservatives and Antioxidants
Excipient | Maximum Limit in USP |
---|---|
Mercurial compounds | 0.01% |
Cationic surfactants | 0.01% |
Chlorobutanol | 0.50% |
Cresol | 0.50% |
Phenol | 0.50% |
Sulfur dioxide or an equivalent amount of the sulfite, bisulfite, or metabisulfite of potassium or sodium | 0.20% |