Articles

Learn how to avoid data integrity breaches and comply with increasingly strict regulatory requirements using informatics for electronic data capture and record-keeping.

Data Integrity in the Pharma Space

Meeting detection challenges presented by nitrosamine impurities
Determination of NDMA and nitrosamine impurities using triple-quadrupole LC/MS
Determination of genotoxic impurities in ranitidine APIs and drug products



Identifying and Quantifying Mutagenic Impurities in Pharmaceutical Products

Understanding USP  Water for Pharmaceutical Use
On-line microbial instrumentation for real-time control of water quality
Real-time TOC analysis of water purity
 

Best Practices for Ensuring the Purity of Pharmaceutical Water

This application note describes key activities to accelerate biopharmaceutical tech transfer to support faster development and manufacturing programs.

Accelerating Biopharmaceutical Tech Transfer to Address Unmet Medical Needs

Tablet press design innovation has traditionally centered on large-scale production equipment, however, there is increasing focus on the smaller-scale, mid-range models that must have the capability to support product development, scale-up, tech transfer, clinical batch manufacturing, small and medium batch production, and continuous manufacturing applications. This range of capabilities demands unique features and design flexibility. 

Critical Requirements of the Mid-Range Tablet Press

A Technical Review of Twin Screw Extrusion Technologies for Life Science Applications

Discover how platforms drive efficiency and get products to market faster.
See why data connectivity improves quality and leads to better outcomes.
Learn how to transform quality from an obligation to a business accelerator

Connecting and Leveraging Quality-Driven Data Throughout the Pharmaceutical Product Life Cycle

Drug developers are increasingly using topical dosage forms for numerous reasons, but several factors must be considered to optimize the API's functionality including excipient selection. Trends and Formulation Strategies for Topical Drugs explores this topic and other areas of interest to developers.


Trends and Formulation Strategies for Topical Drugs

-Stability testing for clinical trial materials
-New services for oral solid dosage forms
-Sourcing global clinical trials in the U.S. and Japan

All Whitepapers