A simple, specific, accurate and precise spectrophotometric stability indicating method is developed for determination of itraconazole in the presence of its oxidative degradation product and in pharmaceutical formulations. A newly developed spectrophotometric method called ratio difference method by measuring the difference in amplitudes between 230 and 265 nm of ratio spectra. The calibration...

A novel colorimetric assay for gabapentin in bulk drug and capsules has been developed via a safety-and-sustainability concerning concept. The method relied on the reaction of primary amino group of drug with non-toxic and eco-friendly genipin in totally aqueous medium to form the blue product which was subsequently measured by visible spectrophotometry at 590 nm. Under the optimized conditions...

The United States Pharmacopeial Convention (USP) Therapeutic Peptides Expert Panel was formed in 2013 to evaluate quality attributes for synthetic peptides based on currently available regulatory guidance and expectations. Public quality standards for drug products and drug substances are developed by USP and enforceable by FDA. This series of three articles by the Panel explores the current ma...

David W. Newton, BS, PhD, FAPhA Bernard J. Dunn School of Pharmacy Shenandoah University Winchester, Virginia Lawrence A. Trissel, BS, RPh, FASHP M.D. Anderson Cancer Center The University of Texas Houston, Texas Editor’s Note In January 2004, Chapter <797> in the United States Pharmacopeia 27 became the first practice standards for sterile pharmacy compounding in US history that may be enforce...

The tests described hereafter will allow quantitative enumeration of mesophilic bacteria and fungi that may grow under aerobic conditions. The tests are designed primarily to determine whether a substance or preparation complies with an established specification for microbiological quality. When used for such purposes, follow the instructions given below, including the number of samples to be t...