Using Tandem LC-MS for Cleaning Validation
The author describes how liquid chromatography-mass spectrometry works and explains some of its advantages and disadvantages.

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Alternative Solvents for Extractables and Leachables Evaluation
The authors examine alternative solvents for evaluation of process components that provide extraction equivalence and do not interfere chromatographically.

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California State Assembly Passes Biosimilar Legislation
The California State Assembly becomes the latest state to specify requirements allowing substitution of biosimilars.

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Eisai Files Petition Against DEA
Eisai files a petition with federal appeals court to require the Drug Enforcement Agency to put anti-epilepsy drug Fycompa on the controlled list of substances.

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Cubist Pharmaceuticals Recalls Vials With Glass Particulate
Cubist issued a voluntary recall of four lots of vials due to the presence of particulate matter.

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Cyber Security Standard Defines Requirements for Industrial Automation and Control Systems
A new standard from the International Society of Automation addresses information technology security solutions for manufacturing applications.

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Roche's Timesaving Formulation for Breast Cancer Drug Approved in Europe
The new subcutaneous formulation of Herceptin can be administered six times faster than the standard intravenous formulation.

Novartis' MS Drug Gilenya Under FDA Investigation for PML Case
FDA has issued a safety alert after a patient with multiple sclerosis in Europe developed a rare and serious brain infection known as progressive multifocal leukoencephalopathy following treatment with Gilenya (fingolimod).

Hospira Issues Nationwide Recall Of Aminosyn II
Hospira has initiated a voluntary nationwide user-level recall of Aminosyn II, due to a foreign particle included in the injection port.

BioReliance Updates Big Blue Mouse Assay Service
BioReliance updates Big Blue Mouse Assay service to meet OECD test requirements.

Sobi Submits Application for Orfadin to EMA
Sobi’s application for Orfadin oral suspension has been validated by EMA.