Analytics

The rapid testing of biologic raw materials can lead to greater efficiency.

Bruker's InsightMR software for on-line NMR analysis enables real-time data analysis and acquisition control for process monitoring.

Shimadzu’s Nexera MP UHPLC Front End system for LC/MS is perfect for LC/MS analysis conducted in pharmacokinetics and synthesis stages in drug detection processes.

In this article, industry experts discuss critical analyses for demonstrating biosimilarity.

USP announces an implementation date of Jan. 1, 2018 for General Chapters Elemental Impurities-Limits and Elemental Contaminants in Dietary Supplements.

The agency outlines recommendations for the development and submission of near infrared analytical procedures.

The commission adopts 24 new and 72 revised texts for inclusion in the European Pharmacopoeia.

The BallProbe from MarqMetrix is an optical sampling interface for inline, real-time measurements.

NSF's consensus-based standard incorporates multiple regulatory and industry requirements into a single rigorous standard for the manufacturing and distribution of pharmaceutical excipients.

Analytical technologies must accurately identify and measure the critical material attributes of APIs and excipients.

PAT has aided formulation, both pre-and post-filing, by reducing costs and time frames.

Assessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.

The pharmaceutical manufacturing platforms of fluid-bed granulation and milling are widely used to modify particle size. However, the adoption of process analytical technology to monitor and control these processes is difficult because of their dynamic nature. This study examines the efficacy of a particle characterizing technology to capture particle images under dynamic conditions and to calculate particle size distribution data both in-line and at-line during fluid-bed granulation and milling.

MedImmune will provide funds and access to monoclonal antibodies to seven postdoctoral associates for the creation of protein measurement and characterization tools.

The all-synthetic 3M Emphaze AEX Hybrid Purifier contains both an anion-exchange nonwoven media and a fine-particle, bioburden reduction membrane.

Shimadzu’s Nexera Method Scouting system provides an outstanding platform for efficient HPLC method development and implementation. It is based on the Nexera X2 next-generation ultra-high performance liquid chromatograph, an all-round LC system for ultra-high-speed analysis.

Ligand-binding assays are fundamental to characterizing biosimilars.

Shimadzu, one of the world leaders in analytical instrumentation, has introduced the i-series of integrated HPLC and UHPLC systems.

New drugs submitted for approval in Europe have 18 months to comply with new elemental impurities guidelines.

USP establishes Jan. 1, 2018 as the implementation date for its elemental impurities guidelines for existing drugs.

The choice of dilution schemes can minimize solution preparation errors.

Analytical and procedural deficiencies result in FDA warning letter for Novacyl Wuxi Pharmaceutical.

Symbion QT chemometrics software provides Parametric Data Cleaning to handle data compromised by excessive noise or other artifacts.

Advanced analytical methods are speeding up the targeted evaluation of potential viral contaminants.

Methods must be suitable at each development phase, robust, and effective on multiple platforms.

Analytical procedures and method validation should be developed with a structured and rigorous approach.

The authors present a validation study of an analytical method for the simultaneous determination of nine human cytokines in human K2-EDTA plasma.

The authors describe a rapid, single-point calibration approach for ICP–MS analysis of raw materials used in drug product manufacturing.

Industry players form Allotrope Foundation to solve analytical data management problems.

Recent technology introductions demonstrate that accuracy, efficiency, and usability are top of mind for pharmaceutical industry professionals for analytical instruments.