American Pharmaceutical News In Review

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October 09, 2023

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Packaging-Related Nitrosamines in Drug Products

For many years it has been known that pharmaceutical elastomers were a potential source of nitrosamines in drug products. But with the increased regulatory focus on nitrosamines, other pharmaceutical packaging constituents have become suspect. Extractables screenings of primary and secondary packaging materials and leachables screenings of the drug products can assist in the risk evaluation and assessment for the presence of nitrosamines in the drug products.

	Industry News

AbbVie to Acquire Mitokinin, Strengthening Neuroscience Pipeline
AbbVie announced that it has exercised its exclusive right and completed the acquisition of ... read more »

Watson-Marlow Builds Cased Pumps for Biotechnology
Developed for biotechnology applications, WMFTS’ range of peristaltic pumps offers an industry-... read more »

Watson-Marlow Wins Gold at MassEcon Economic Impact Awards
Watson-Marlow’s Devens site has been recognized as a Gold Awardee at the MassEcon Economic Impact ... read more »

Lilly Announces Leadership Transitions
Eli Lilly and Company announced changes to its executive leadership team. Mike Mason, executive vice... read more »

	QC Corner

QC Corner: Automated Data Integrity in Sterility Testing
Pharma 4.0 transformation processes are reaching microbiological QC labs, using automation, robotics... read more »

	Infographic

Data Integrity in Pharmaceutical Quality Control
This infographic gives an overview on important terms and definitions, points of compliance, and ways to achieve quality control and data integrity. read more »

	Featured Articles

		Leveraging Analytical Technology Process for CMC In the evolving field of pharmaceutical development, the implementation of Process Analytical Technology (PAT) for manufacturing is an essential ... read more »

		Regulatory Submissions for Rapid Microbiological Methods (RMMs) More than twenty years ago, companies started introducing rapid microbiological methods (RMMs) to the industry. Some call these methods alternative ... read more »

	Featured Video

On-Demand Webinar: Detecting Contaminants, Ensuring Safety: A Closer Look at Our New High-Performance Mycoplasma Testing Solution
In this webinar, hear from Sharon Rouw, Senior Product Manager at Thermo, as she discusses discuss the benefits and performance characteristics of ... watch »

On-Demand Webinar: The Ultimate Guide to Fluid Transfer Systems: From Selection to Maintenance
Fluid transfer is vital across industries, but it comes with challenges like material selection, kinking, and contamination. Join us to master these, ... watch »

	Featured Products

Pearlitol 200GT
Barentz PEARLITOL® 200 GT mannitol is a direct compression excipient, specially designed to reduce capping ... learn more »

Pearlitol 200SD
Barentz PEARLITOL® 200 SD / Mannitol is a direct compression excipient. Rotary press tablet simulator ... learn more »

Lasair Pro
Particle Measuring Systems The Lasair Pro supports a complete contamination control solution including clean area monitoring (... learn more »

	Featured Whitepaper

Whitepaper: Extractables and Leachables Testing
Our scientists have a thorough working knowledge of plastics, rubber, and elastomeric materials, those compounds most frequently used in today’s pharmaceutical manufacturing, packaging, and delivery ... read more »

Brochure: Annex 1 Ready — Reliable, Confident Environmental Monitoring
Are you compliant with the new EU GMP Annex 1? It’s easy with TSI environmental monitoring systems for pharmaceutical manufacturing cleanrooms that include the BioTrak™ Real-Time Viable Particle ... read more »

	More Products

Thermo Scientific™ Pharma 16 Twin-Screw Extruder Learn More
Zetasizer Nano ZS Size Analyzer Learn More
Uphill Tablet Deduster Learn More

	Directory Categories

Pharmaceutical Incubators Search More

Pharmaceutical Calorimeters Search More

Pharmaceutical Excipients Search More

	Events

AAPS PharmSci 360
Orlando, FL – 10/22/2023
PharmSci 360 delivers research from across the pharmaceutical continuum, from discovery to delivery, and all stages in between. Thousands of ... event details »

ISPE Annual Meeting & Expo
Las Vegas, Nevada – 10/15/2023
The 2023 ISPE Annual Meeting & Expo is focused on excellence, modernization, and harmonization in pharmaceutical science and manufacturing across the ... event details »

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