Preservatives regulatory compliance

If a multidose formulation is required, an antimicrobial agent, also called a preservative, must be added to the formulation for regulatory compliance. The preservative must meet USP requirements and the Antimicrobial Effectiveness Test as stated in the USP. The most often used preservatives for proteins or recombinant products are phenol at 0.3 to 0.5% chlorobutanol, also at 0.3 to 0.5%, and benzyl alcohol at 1.0 to 3.0%. 

Lower overall costs—The combination of permanent protection and the net effect of minimizing hazardous waste disposal cleanup, regulatory compliance and insurance provides the ultimate solution for wood preservation. 

The multidose formulation will be tested to determine its efficacy according to the Antimicrobial Effectiveness Test required by the USP.39 If the results support the USP requirements, international requirements must then be met. International markets require different preservatives, different concentrations, and different excipients of the formulation. In addition, the period required for the inhibition and/or killing of the challenge microorganisms may be different. International regulatory requirements for compliance should be well researched and understood by the scientific and the management staff. 

Regulatory FDA 21CFR 176.170, 176.210, 177.1010, 177.1210, 177.2800,178.3910 FDA approved for topicals NF compliance Manuf./Distrib. Aldrich Ashland ChemService Cognis/Chems. Group Croda Inc Fluka Hickson Welch Ltd Jarchem Ind. Lanaetex Prods. M. Michel Mosselman NV Penta Mfg. R.W. Greeff Rhodia HPCII Sea-Land Sigma Spectrum Quality Prods. Universal Preserv-A-Chem Whyte Chems. Ltd Trade Names HD-Ocenol 90/95V... 

Regulatory FDA 21CFR 175.105 NF compliance Manuf./Distrib. Alfa Chem ChemService Chemial SpA J.T. Baker Morflex Penta Mfg. Reilly Ind. Spectrum Quality Prods. Unitex Universal Preserv-A-Chem... 

---