Procaine hydrochloride Injection | Mepivacaine hydrochloride Injection |
Pentazocine Lactate Injection | Bupivacaine Hydrochloride Injection |
Epinephrine Injection |
Acetone sodium bisulfite may be used in injectable formulations for several purposes, including as a preservative and antioxidant. Here’s how it can be utilized in these pharmaceutical formulations
Preservative Action
Acetone sodium bisulfite functions as a preservative in injectable formulations by inhibiting microbial growth and preventing contamination of the solution. The release of bisulfite ions upon dissolution creates an acidic environment that inhibits the proliferation of microorganisms such as bacteria and fungi. This helps maintain the sterility and safety of the injection solution during storage and use.
Antioxidant Properties
Acetone sodium bisulfite serves as an antioxidant in injectable formulations by scavenging free radicals and reactive oxygen species. This helps prevent oxidation reactions that may degrade the active pharmaceutical ingredients (APIs) or other components in the formulation. By protecting against oxidative degradation, acetone sodium bisulfite helps maintain the stability and potency of the injection solution over time.
Stability Enhancement
By preventing microbial contamination and oxidative degradation, acetone sodium bisulfite contributes to the overall stability of injectable formulations containing Mepivacaine Hydrochloride, Pentazocine Lactate, Bupivacaine Hydrochloride, or Epinephrine. It helps ensure that the solutions retain their chemical integrity, potency, and sterility throughout their shelf life, even under conditions of storage and handling.
Compatibility
Acetone sodium bisulfite is generally compatible with the active ingredients and other excipients used in injectable formulations of Mepivacaine Hydrochloride, Pentazocine Lactate, Bupivacaine Hydrochloride, and Epinephrine. It does not adversely affect the chemical or physical properties of these components and does not cause significant changes in pH or osmolarity that may impact the compatibility of the formulation with physiological conditions.
Regulatory Compliance
The use of acetone sodium bisulfite in injectable formulations is subject to regulatory guidelines and pharmacopeial standards. These standards define permissible concentrations, acceptable purity criteria, and specific testing requirements to ensure the safety, quality, and efficacy of the injection solutions.