Analytics

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

Aggregation System Improves Analysis of Sub-Visible Particles

Microscope Enables High-Resolution Materials Analysis

Laser Diffraction Software Supports Analytical QbD

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

7900 ICP-MS Increases Efficiency

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.

Compact Mass Spectrometer Improves Analysis

ACQUITY QDa Detector Increases Productivity

Advances in technology are improving the sensitivity and accuracy of mass spectrometry, increasing its use for the analysis of extractables and leachables.

Advanced triple quadrupole technology for improved performance and ease of use.

Automated sample handling, advanced glycan analysis, and specially designed columns are help speed up confirmation of the biosimilarity.

Simple and affordable mass detection for the chromatographer.

For a drug-development process that relies on outsourced services, special considerations are needed to ensure the proper transfer of technology and information from one phase to the next.

New simulation software improves modeling for chemists and materials scientists.

USP announced the approval of General Notices section 5.60.30 Elemental Impurities in USP Drug Products and Dietary Supplements with an official date of Dec. 1, 2015.

NMR analysis provides crucial structural information of synthesized glycans while LC-MS/MS is ideal for quantitation of free sugars in biological matrices.

Antibody fragments pose unique challenges in terms of recovery, purification, and formulation.

Roger Hayes of MPI Research discusses highly potent drug development.

Analytical tests, correlated with statistical techniques, are used to predict material behavior.

Covance Inc. and Pathoquest have announced a collaboration to provide next-generation sequencing (NGS) based biosafety assessments to detect and identify viral contaminants within biologic compounds.

As the pharmaceutical industry prepares for changes to compendial and regulatory standards for elemental impurity analysis, QA/QC and laboratory scientists are tasked with adapting their operations to include data management, analysis, and reporting based on inductively coupled plasma–mass spectrometry (ICP–MS).

Mass detection at the push of a button could change the way many laboratories carry out their chromatographic analysis.

Pfizer, Eli Lilly, and several other pharmaceutical companies are participating in the development of automated sampling technology and associated software that improve process control and reduce development times in biopharmaceutical manufacturing.

The Waters ACQUITY QDa Detector is a mass detector designed to bring high-quality, mass spectral data to chromatographic separations.

LCMS-8050 Mass Spectrometer Increases Quality Analysis

The authors evaluated a variety of materials of construction (MOCs) and found that visible residue limits (VRLs) were higher on some MOCs than on stainless steel. The optimal viewing conditions were dependent on the MOC and the viewing background. The risk of a cleaning failure due to visual failure for different MOCs can be mitigated or eliminated using complementary cleaning validation studies.

Software Improves Monitoring of Pharmaceutical Ingredients

The authors discuss a strategy for developing a risk-based approach for testing of elemental impurities in leachable studies.

The characteristics of tableted solid dosage drugs often depend on the granulation process, so selecting the most appropriate granulation technique and monitoring the process are crucial