Analytics

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Articles

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

Elemental Impurities General Chapter Revisions Move Forward

Amy Ritter is Scientific Editor, BioPharm International and Pharmaceutical Technology. Amy Ritter joined the editorial staff of BioPharm International and Pharmaceutical Technology in 2011. She received her BA in Biology from Boston University, and holds a PhD in Neurobiology from SUNY at Stony Brook. Before joining Advanstar’s Pharm Sciences group, she worked in the preclinical pharmacology group at Merck Research Labs, and is the author of numerous peer-reviewed scientific publications.

Amy Ritter was Scientific Editor, BioPharm International.

FDA announced the availability of the guidance â€œQ11 Development and Manufacture of Drug Substancesâ€ in the Nov. 20, 2011 edition of the Federal Register.

FDA Adopts Final Version of Q11 Guidance

In Part III of a three-part article, the authors examine various degradation routes of APIs, impurities arising from interactions in formulations, metabolite impurities, various analytical methods to measure impuritie, and ways to control impurities.

Evaluating Impurities in Drugs (Part III of III)

In Part I of a three-part article, the authors discuss what constitutes an impurity and the potential sources of impurities in APIs and finished drug products.

Evaluating Impurities in Drugs (Part I of III)

The sixth in a series of eight case studies from the Product Quality Research Institute focuses on packaging line GMP optimization.

PQRI Case Study (6): Packaging Line GMP Optimization

The authors examine risk management relating to the quality issues of clinical-trial materials and discuss areas that would benefit from additional consideration and harmonization.

Quality Issues for Multiregional Clinical-Trial Materials

Elham Blouet is Pharmaceutical Project & Development Manager, Pharmaceuticals & Cosmetics BU, at Roquette.

Elham Blouet from Roquette explains the importance of carbohydrates for injection and the challenges in this niche market.

Carbohydrates For Injection

Highly potent APIs (HPAPIs) represent a growing area of interest for the pharma industry. Mark Griffiths, CEO of Carbogen Amcis AG, explains why.

Highly Potent; Highly Challenging?

A Q&A with Brian Johnson, senior director of supply chain security at Pfizer, moderated by Patricia Van Arnum. Part of a special Ingredients issue.

Addressing Ways to Improve Supply-Chain Security: A Perspective from Pfizer

FDA recently published guidance for preventing the cross-contamination of finished pharmaceuticals and active pharmaceutical ingredients with nonpenicillin beta-lactam antibiotics.

Drug Substance Analysis