Analytics

The United States Pharmacopeial Convention (USP) has agreed to work with the US Food and Drug Administration on developing more sensitive tests for detecting contaminants such as over-sulfated chondroitin, which was found in batches of heparin last January.

Also, GSK expands in Ireland, executive appointments at ProGenTech, more...

The US Food and Drug Administration issued a final guidance last week regarding investigational new drug applications for human gene therapy.

Also, Alcon plans to open Singapore facility, Pharmacopeia president and CEO retired, more...

Also, Jubilant Organosys to acquire DRAXIS Health, PPD's Paul Covington to retire, more...

Combining atomic force microscopy and infrared spectroscopy, scientists at the University of Illinois have demonstrated a method for simultaneous structural and chemical characterization of samples at the femtogram (10-15g) level.

The US Food and Drug Administration withdrew a direct final rule that changed current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. The agency withdrew the rule because it received significant adverse comments from industry.

Also, VaxGen and Raven terminate merger agreement, Darren Head appointed CEO of Cytovance, more...

A changing regulatory environment is on the horizon for excipient suppliers and users.

The authors developed a reliable spectrophotometric method for determining and measuring trace amounts of lead in various samples.

The FDA itself issues a cry for help. Is anybody listening?

Regulatory agencies expect companies to establish and monitor clean equipment- and dirty equipment-hold times for manufacturing equipment as part of their cleaning validation program.

Also, Alkermes announces restructuring and reduction of workforce, Icagen announces several senior management promotions, more...

The US Pharmacopeial Convention announced a revised glycerin monograph in the United States Pharmacopeia.

Also, Pipex Pharmaceuticals implements cost-cutting measures, Pfizer's Senior Vice-President and General Counsel Allen Waxman leaves the company, more...

This year, INTERPHEX will take place in Philadelphia, Pennsylvania, on March 26?28. Equipment and Processing Report asked RJ Palermo, industry vice-president of Reed Life Sciences and INTERPHEX, to share his thoughts and expectations about the upcoming event.

Concerns over contaminated heparin product worsened as US officials announced dialysis patients in Germany have fallen ill after using a different brand of the blood thinner than was already being recalled.

Also, PDL BioPharma will no longer pursue sale of the company, executives resign from Topigen Pharmaceuticals, more...

The 59th Pittsburgh Conference gathered more than 1000 exhibitors on its showroom floor this week.

Also, Millipore plans to open Singapore facility, Michael J. Simms joins Alexza Pharmaceuticals, more...

After two centuries, there's no reason to maintain two tablet compression tooling standards.

The United States Pharmacopeia emphasizes mechanical calibration and a performance test to esnure integrity of the dissolution procedure.

New research and ideas for March 2008

Chemical imaging of solid dosage forms has become a powerful analytical tool for the development of solid dosage forms.

Using a handheld Raman spectrometer, the authors developed methods for 28 commonly used excipients and active ingredients.

The selection of an appropriate salt form for a potential drug candidate is an opportunity to modulate its characteristics to improve bioavailability, stability, manufacturability, and patient compliance.

Editors' Picks of Pharmaceutical Science & Technology Innovations; Analytical system provides multiuser capability; Encapsulator aids dosage design; Versatile drive offers quick setup

The European Union's REACH initiative has the potential to affect the flow of chemicals into the pharmaceutical suppy chain.

Show blasts off this month in Philadelphia with more suppliers, new trends, and real-world solutions.

A news roundup for March 2008.