Articles

The challenges for new drugs looking to enter the market are numerous. But many are self-inflicted – especially in small molecule development. A dangerous perception persists that aside from highly potent APIs, small molecule medications have simple process requirements. The reality, however, is that most APIs will require numerous steps or significant work upfront to avoid development delays, rework or outright failure.

Six API Challenges That Could be Slowing Your Development


•	How to balance compliance needs with creating useful SOPs.

•	Tips and tricks for ensuring consistency.

•	Why and how you should test your SOPs


How to Avoid GMP Audit Citations Caused by Documentation Issues

from A technical review of compounding, devolatilization, reactive processing, foaming and direct extrusion via twin screw extruders

Continuous twin screw extrusion system for soft gel casing replaces batch mixing operations

Learn how regulators define temporary data and how to maintain data integrity. Find out what to look for in a LIMS for 21 CFR Part 11 and Annex 11 compliance.

Understanding 21 CFR Part 11/Annex 11 Compliance

Detecting the presence and depth of penetration of drug compounds in skin can prove challenging, current technologies fail to achieve adequate penetration through layers of dermal tissue. In this study, Raman spectroscopy using the Renishaw Biological Analyser - RA816 confirmed the presence of a topical compound in the epidermis and reticular dermis with high specificity and sensitivity.

Monitoring of transdermal drug delivery in skin using the Renishaw Biological Analyser

This article describes how a Japanese pharmaceutical company successfully implemented the Agilent RapID Raman system for GMP raw material testing through unopened brown paper sacks, and other opaque containers.

GMP Testing of Raw Materials Through Containers using Spatially Offset Raman Spectroscopy

This application note covers HRAM multi-attribute method for critical quality attribute monitoring and new peak detection, including optimization and application.

HRAM MAM for Analysis of mAb CQAs

Spray drying continues to gain importance as a preferred manufacturing technology for amorphous solid dispersions (ASD). A fast carrier selection allows for a more targeted development process with reduced time to market. EUDRAGIT® polymers have not only been proven to be superior with respect to ASD formations but can also stabilize the amorphous state of the API over storage.

Spray drying for enhancing the solubility of poorly soluble drugs

At Rite-Hite, we have many solutions for the pharmaceutical industry along with the knowledge and experience to help you address the issues you face with your clean areas. We keep up-to-date on best practices, new design and technology, and the latest trends in the industry.

The Essential Guide: Cleanrooms and Clean Areas

This application note demonstrates the capabilities for Dual LC to run independent HPLC and UHPLC methods simultaneously using one instrument.

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