Peer-Review Research

Oct 02, 2014
Pharmaceutical Technology
Calculate a risk-based guard band associated with reportable values derived from knowledge of the analytical procedure capability.
Oct 02, 2014
Pharmaceutical Technology
Review challenges in the use of normality testing situations and recommendations on how to assess data distributions in the pharmaceutical development manufacturing environment.
Sep 02, 2014
Pharmaceutical Technology
Febuxostat is a novel, non-purine, selective inhibitor of xanthine oxidase for hyperuricemia in patients with gout. It is the first promising substitute for allopurinol in 40 years. Various synthetic routes to febuxostat, as well as polymorphic forms and impurities of the drug, are reported in the literature. The authors have also identified several impurities that result from the synthesis of febuxostat. This article describes the identification and control of all isomeric, carryover, and byproduct impurities of febuxostat and its intermediates.
Aug 02, 2014
Pharmaceutical Technology
A techno-economic profiling method supports pharmaceutical process development by helping identify the best manufacturing approach.
Jul 02, 2014
Pharmaceutical Technology
The authors look at the cleanability of pharmaceutical soils from a variety of materials of construction to determine the relative ease of cleaning and explore potential grouping strategies as part of a comprehensive cleaning validation program.
May 02, 2014
Pharmaceutical Technology
Zero-order release of a freely water-soluble active drug can be obtained using release-controlling polymers.
Apr 02, 2014
Pharmaceutical Technology
A new process analytical technology based on impedance spectroscopy has potential applications for characterizing product attributes during the freeze-drying process.
Mar 02, 2014
Pharmaceutical Technology
In this article, the authors demonstrate that a normal-phase chromatographic method was stability-indicating for a water-sensitive prodrug. The stress conditions using aqueous and non-aqueous conditions were also compared to understand the information obtained with each approach.
Mar 02, 2014
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The extended-release performance of drug-loaded pellets manufactured by two methods, drug layering and direct pelletization, was compared.
Feb 02, 2014
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The authors describe the development of a stability-indicating reverse-phase high-performance liquid chromatographic (RP?HPLC) method for the quantitative determination of potential genotoxic impurities present in pemetrexed disodium (form-IV). The chromatographic separation was achieved on a RP?HPLC column (Zorbax SB-Phenyl, Agilent) at ambient temperature with gradient elution using mobile phase A (trifluoroacetic acid [TFA] in water) and mobile phase B (TFA in acetonitrile).
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