Analytics

Sanjay Garg, PhD, is an associate professor at the School of Pharmacy, University of Auckland, Auckland, New Zealand, and a member of the Pharmaceutical Technology Editorial Advisory Board.

Articles

A book about pharmaceutical analysis engages the reader with history and unexpected asides.

A Peak in Mass-Spectrometry Literature

Asish B. Chakraborty is a senior scientist at Biopharmaceutical Sciences, Waters Corporation, 34 Maple Street, Milford, MA 01757.

Weibin Chen is a principal research chemist at Biopharmaceutical Sciences, Waters Corporation, 34 Maple Street, Milford, MA 01757.

John C. Gebler is a senior scientist at Biopharmaceutical Sciences, Waters Corporation, 34 Maple Street, Milford, MA 01757.

The authors developed a method to accurately measure the average molecular weight of large poly(ethylene glycols) (PEGs) using ion-mobility time-of-flight mass spectrometry coupled with gas-phase ion–molecule reactions.

Improved Mass Determination of Poly(ethylene glycols) by Electrospray Ion-Mobility Time-of-Flight Mass Spectrometry Coupled with Ion–Molecule Reactions

USP 467 Residual Solvents will take effect on July 1, 2008. But does the industry understand these specifications-and is it prepared?

Clearing the Air on Residual Solvents

The authors review methods for reducing analysis time and increasing throughput that are reliable and maintain data integrity.

Achieving Ultrafast Liquid Chromatography

Polysaccharide-based chiral stationary phases have been developed that comprise chiral selectors immobilized on their support rather than being physically coated. These materials are completely solvent stable, thereby increasing selectivity and and enabling the development of new chiral selectors that have been too unstable in a coated form for general use.

Polysaccharide-Based Chiral Chromatography Media in HPLC and SFC

Ultrahigh pressure liquid chromatography maximizes efficiency, but, as defined by the resolution equation, the stationary phase is still a crucial consideration when attempting to resolve mixtures of compounds.

Using Selectivity to Optimize UHPLC Separations

A new Raman spectroscopic method to detect magnesium stearate in powder blends and tablets is described. High-volume pharmaceutical manufacturing requires the use of lubricants to facilitate tablet ejection from compressing machines. However, lubricants may also bring a number of undesired problems that have been widely documented in pharmaceutical scientific literature. New analytical methods are needed to understand lubrication and provide process knowledge in support of FDA's process analytical technology initiative. The detection of magnesium stearate in lactose, mannitol, corn starch and other commercially important excipients is reported. The Raman spectroscopic method has a detection limit of about 0.1% (w/w) based on the 2848 cm-1 band that corresponds to the symmetric stretch of the methylene group in magnesium stearate.

A Raman spectroscopic method to monitor magnesium stearate in blends and tablets

Raman spectroscopy has become a commonly used technique for physicochemical analysis that possesses many advantages over other analytical techniques. It is a very attractive characterization tool, not least because it enables measurements in water. However, very few examples of its application in an aqueous environment exist in literature. This paper provides some recent applications of Raman spectroscopy in pharmaceutical material and process characterization when water is present.

Applications of Raman spectroscopy in aqueous environments

This article discusses the advantages and disadvantages of using solid-state NMR spectroscopy for the analysis of pharmaceutical solids.

Solid-State Nuclear Magnetic Resonance Spectroscopy for Analyzing Polymorphic Drug Forms and Formulations

The first part of this article introduced the basic features of Raman spectroscopy and presented some examples of its application in the pharmaceutical industry. This second part focusses on the technique's application as a PAT tool within the pharmaceutical manufacturing environment. FDA's PAT initiative has provided motivation to explore the application of 'new' analytical technologies to the pharmaceutical manufacturing process and Raman spectroscopy shows great promise. The strengths and weaknesses of the technique as a potential PAT tool are discussed together with some examples of how this works in practice in a pharmaceutical manufacturing environment.

Bio/Pharmaceutical Analysis Techniques