Analytics: Approaches in quality assurance and quality control used in pharmaceutical development and manufacturing - Pharmaceutical Technology

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PharmTech

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PharmTech Europe

Analytics
Analytical testing methods in pharma manufacturing. Chromatography, UHPLC, chiral. Near-infrared (NIR) and Raman spectroscopy. Anticounterfeiting. Dissolution testing. Cleaning validation. Extractables & leachables.

Automating Online Sampling of Bioprocesses

July 2, 2014

Pharmaceutical Technology

The Modular Automated Sampling Technology platform allows sampling of bioreactors.

Multifactor Non-linear Modeling for Accelerated Stability Analysis and Prediction

July 2, 2014

Pharmaceutical Technology

The right approach can provide a clear, statistically defendable method for determining dissolution and accelerated stability.

The Role of Powder Characterization in Continuous Manufacturing

June 2, 2014

Pharmaceutical Technology

Experimental work on wet granulation demonstrates the use of dynamic powder characterization to support continuous processing for tablet manufacturing.

Is a Sample Size of n=6 a Magic Number?

June 2, 2014

Pharmaceutical Technology

Statistical analysis shows how much testing is needed to deliver a reliable estimate result.

Selecting a Specimen Holder for X-ray Powder Diffraction

June 2, 2014

Pharmaceutical Technology

Specimen mounting in x-ray powder diffraction affects peak positions and intensities.

Extractables and Leachables Testing

May 2, 2014

Pharmaceutical Technology

Industry experts discuss how extractables and leachables studies are designed using a risk-based approach.

Data Integrity in the Analytical Laboratory

May 2, 2014

Pharmaceutical Technology

Data integrity in the analytical laboratory is an area of increasing focus for regulators such as FDA.

Through-Vial Impedance Spectroscopy: A New In-Line Process Analytical Technology for Freeze Drying

April 2, 2014

Pharmaceutical Technology

A new process analytical technology based on impedance spectroscopy has potential applications for characterizing product attributes during the freeze-drying process.

A New Approach to Forced Degradation Studies Using Anhydrous Conditions

March 2, 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.

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