This paper summarizes parenteral drug contamination case studies presented at industry conferences and a Food and Drug Administration advisory committee meeting in the period of 2000-2004. CGMP deficiencies associated with each contamination event are discussed. The key role of a well-functioning quality system in contamination prevention is emphasized.

OBJECTIVE To test the acceptability and impact of a booklet on chemical additives in cigarettes. METHODS In 2005, 2152 current (59%), former (38%), and never (3%) smokers were enrolled on the Internet and randomly assigned to an intervention group which immediately received a 48-page booklet on cigarette additives by postal mail (n=1074), or to a control group (n=1078). Four weeks later, 1965...

There has been a great increase in the consumption of various food additives in recent years. The purpose of this study was to identify the incidence of sensitization to food additives by using skin prick test in patients with allergy and to determine the concordance rate between positive skin tests and oral challenge in hypersensitivity to additives. This cross-sectional study included 125 (fe...

This report presents the conclusions of a Joint FAO/WHO Expert Committee convened to evaluate the safety of various food additives, with a view to recommending Acceptable Daily Intakes (ADIs) for humans, and to prepare specifications for the identity and purity of food additives. The first part of the report contains a general discussion of the principles governing the toxicological evaluation ...

The phase transition of active pharmaceutical ingredients should be taken into account during manufacturing, processing- and storage, because different crystal forms lead to different physical properties of formulations. The phase transition of clarithromycin (CAM) metastable form I to stable form II was investigated on heating with additives such as fatty acids or fatty acid esters. Differenti...

Reduced lysozyme was renatured by sulfhydryl-disulfide interchange reactions at pH 8.0 in the presence of 4 M urea, with or without additives at 40 degrees C. In the absence of additives, the final folding yield of reduced lysozyme was approximately 40%. In the presence of sarcosine, glycerol, ammonium sulfate, N-acetyl glucosamine and glucose, its folding yields increased in all cases. In part...

KOH-based electrolytes with different salt additives were investigated to reduce their corrosive nature toward Mg/Ni metal hydride alloys used as negative electrodes in nickel metal hydride (Ni/MH) batteries. Alkaline metal halide salts and oxyacid salts were studied as additives to the traditional KOH electrolyte with concentrations varying from 0.005 M to 1.77 M. Effects of the cations and an...

This paper presents research upon the impact of ecological measures on water content new and used oil. Water microorganisms are major factors contamination for engine oils fuels, they lead to a significant reduction in lifetime performance engines. The occur naturally environment, from which enter into oil fuel. Despite various preventive measures, it is not possible completely remove petrochem...