In sufficiently high concentrations, elemental impurities, typically from catalyst residue, can pose safety risks.  The author discusses how x-ray spectrometry can be an effective way to measure these impurities and meet regulatory guidelines.

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The author discusses how x-ray spectrometry can be an effective way to measure these impurities and meet regulatory guidelines.

Meeting USP Guidelines for Elemental Impurity Analysis with X-ray Fluorescence Spectrometry

The author discusses key process parameters and shows how a process optimization template can be used to improve this key operation. 

Optimizing Tablet Compression

Defining quality for excipients may not be as clear cut as it is for APIs, but it is essential to product quality and patient safety, and to choosing the best supplier. The author discusses key areas of focus and presents best practices from the International Pharmaceutical Excipients Council (IPEC).

The author discusses key areas of focus and presents best practices from the International Pharmaceutical Excipients Council (IPEC).

Excipient Quality and Selection

More pharmaceutical companies are becoming interested in continuous processing, but they may face an “analytics gap,” because continuous will require a different approach to analytics. The author discusses issues and best approaches for solid dosage form pharmaceuticals.

The author discusses issues and best approaches for solid dosage form pharmaceuticals.

Filling the Analysis Gap in the Move to Continuous Processing

The authors present analysis of the state of control of intermediate identity and quality, based on analysis of recently submitted DMFs.

Regulatory Considerations for Controlling Intermediates in Type-II Drug Master Files for the Manufacture of Generic Drug Substances

Today, some of the most advanced computer-based models are being used for early research.  However, the move to continuous processing has stimulated interest in process optimization and control. This article explores two commercial platforms, and touches on a new program underway in the UK.

This article explores two commercial platforms, and touches on a new program underway in the UK.

Modeling and Simulation Move Downstream

A number of excipient database efforts are being developed, but are they getting to the essential materials science questions? Stephen Hoag, a professor at the University of Maryland (Baltimore), and a member of the National Institute of Pharmaceutical Technology and Education (NIPTE) offers a brief update on issues, and NIPTE’s database project.

Stephen Hoag, a professor at the University of Maryland (Baltimore), and a member of the National Institute of Pharmaceutical Technology and Education (NIPTE) offers a brief update on issues, and NIPTE’s database project.

Unifying Excipient Databases

As alternatives to gelatin capsules are sought, plant-based alternatives are being improved to address variability issues. Matt Richardson of Capsugel and Michael Morgen of Bend Research, discuss improvements and results that have been seen in the second generation of hydroxypropyl methyl cellulose (HPMC) materials. 

Matt Richardson of Capsugel and Michael Morgen of Bend Research, discuss improvements and results that have been seen in the second generation of hydroxypropyl methyl cellulose (HPMC) materials.

Pharmaceutical Technology-03-15-2016