Analytics

Compositing samples is appropriate under certain circumstances but raises caveats on how and when it should be applied.

The author examines dry dispersion and outlines the related analytical method development.

New capillary-based imaging techniques for protein charge variant analysis are reducing development and start-up times for protein-based therapeutics.

Increasing production efficiency while ensuring high parenteral product quality is the goal of both manual and automated visual inspection systems.

Shimadzu's LCMS-8040 combines newly improved ion optics and collision cell technology with proprietary ultrafast technologies.

The process-driven system reduces total cost of ownership.

Iterative and multiple incremental advances in particle-characterization technology are making a difference in pharmaceutical analysis applications.

The authors describe a method-validation-by-design (MVbD) approach to validate a method over a range of formulations using both design-of-experiment and quality-by-design principles to define a design space that allows for formulation changes without revalidation.

Bristol-Myers Squibb embarks on a multi-year journey to overcome the challenges of serialization and reap the benefits.

Thermo Fisher Scientific Inc. launched new software, instruments, consumables, and services for analytical applications at Pittcon 2013.

Shimadzu Scientific Instruments introduced several new products at Pittcon 2013.

At Pittcon 2013, Water Corp. announced improvement to chromatography systems and software.

Ultra high-pressure liquid chromatography (UHPLC) is enabling faster product development and production batch approvals with increased sensitivity.

Instrument manufacturers and testing service providers are offering improved tools to biologic charaterization.

The authors present topics discussed and conclusions that resulted from the PDA QbD workshop.

Industry experts discuss the effect FDA's 2011 process validation guidance has had on industry.

Applying quality-by-design and process analytical technology facilitates process understanding and control of various operations in lyophilization.

QbD paradigm advances process understanding in development and manufacturing.

New product reviews for March 2013, featuring automation, IT, and process control systems.

New handheld Raman technology is helping improve raw-material analysis and counterfeit-drug detection.

Equipment purchased today for the packaging line should be serialization-ready in preparation for upcoming requirements.

Even in an industry in which all product development is complicated by the intricacies of human biology, orally inhaled products (OIP) stand out as singularly demanding.

Recent activity in standards-setting organizations has raised interest in the impact of testing for impurities that may enter the product before it is mined or harvested or even due to intentional use of some reagents.

Revisions to the United States Pharmacopeia (USP) General ChapterHeavy Metals have been much discussed over the past decade.

Advances in data loggers and radio-frequency identification tags help meet the increasing need for managing the pharmaceutical cold chain.

The authors discuss the valuable information that can be obtained from indexing and its applications in routine screening and analysis of solid forms.

Tim Freeman of Freeman Technology explains how new analytical technologies have influenced quality criteria and standards for the uniformity of dosage units, and why more accurate systems are leading to greater focus on tablet scoring.

Magnetic separation equipment reduces ferrous metal contamination.

A few years ago, drug criminals would put all their efforts into matching packaging and labeling, or manufacturing good-looking fake materials. Today, criminals are capable of much more.

Can postapproval FDA filings immunize pharma companies from patent lawsuits?