Analytics

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.

MedImmune enters into an agreement to acquire the image analysis and data mining company.

A range of balance models cover a weighing capacity from 60 to 8200 grams.

A risk-based approach is recommended for analytical method comparability for HPLC assay and impurities methods.

Data analytic strategies can help companies capitalize on personalized medicine.

Review challenges in the use of normality testing situations and recommendations on how to assess data distributions in the pharmaceutical development manufacturing environment

A risk-based guard band surrounds a specification limit and is derived from the uncertainty of the reportable value of the analytical procedure, which includes the uncertainty in the reference standard. The author discusses requirements for generating a reportable value and calculating the associated measurement uncertainty.