Form and Specification of Product Bacteriostatic Water (0.9% Benzyl Alcohol) is supplied as a clear, sterile, non-pyrogenic solution packaged in a sealed 10 mL multi-dose glass vial manufactured under controlled laboratory conditions
[DOI] [PubMed] [Google Scholar] 171.Wang X, Donghui LI
If they are going to be used they should be made according to a USP monograph or be a component of an approved drug, if no monograph exists it must be on the 503A Bulk List, and it must be manufactured in an FDA registered facility with a proper certificate of analysis
The candidate provided clinically meaningful weight loss, according to Novo, with the 11.8% weight reduction comparing to 2.3% in patients who received a placebo, in combination with lifestyle changes
The controlled composition and sterile preparation allow the solution to be used in experimental protocols requiring high-purity solvent systems