LCGC North America-01-01-2007

The current final FDA guidance document discussing the revised scope and applicability of 21 CFR Part 11 clearly adopts a risk-based approach to Part 11 compliance. This is certainly a very pragmatic approach and one that many regulated firms had adopted even before the recent release of this document. This article will discuss the particulars of a risk-based approach to Part 11 compliance. The favored risk assessment protocols such as HACCP, FMEA and FMECA will also be addressed as well as how one can apply them to 21 CFR Part 11 compliance.

Emerging as a complementary analytical tool to LC-MS, LC-ICP-MS brings added value to the determination of inorganic element containing molecules of biological importance.

Thermo Fisher Scientific, Inc. (Waltham, Massachusetts) announced it has acquired Cohesive Technologies, Inc. (Franklin, Massachusetts), a manufacturer of advanced sample extraction and liquid chromatography products. Cohesive has annual revenues of approximately $15 million.

Although the majority of solid-phase extraction (SPE) is performed with conventional bonded silica- and polymeric-phases, difficult and complex samples may require more specialized stationary phases. In this installment of "Sample Prep Perspectives," columnist Ron Majors discusses advanced topics such as multimodal SPE, restricted-access media, molecular imprinted polymers, immunoaffinity extraction phases, and other class- or compound-specific sorbents. These phases provide additional selectivity, and procedures using them can be automated. Representative applications will be presented.

Capillary extraction (CEx) is used to study the solventless in-tube extraction of naphthalene, acenaphthene, phenanthrene, fluoranthene, chrysene, benzo(a)pyrene and coronene in aqueous samples prepared by analyte spiking into clean waters or, as an alternative, by using the generator–column method of sample preparation. Analysis of laden extractors is conveniently performed by high-resolution gas chromatography (GC), with a flame-ionization detector (FID). Extraction set-ups and main extraction variables are investigated from a practical point of view. For 2- to 4-ring polycyclic aromatic hydrocarbons (PAHs), equilibrium times are within a few minutes, analytical sensitivity is in the parts-per-billion (ppb) range and reproducibility is better than 10% relative standard deviation (RSD) (n = 6). Coronene behaviour is unique and presumably determined by extreme hydrophobicity and thus very negligible aqueous solubility: in-tube extraction of coronene seems possible only if starting from..

Chromatographers worldwide suffer from the same problems.

The environmental market peaked about fifteen years ago when the United States government passed a large body of new environmental laws and strengthened existing ones, dramatically increasing the number of mandated tests. As a result, the analytical instruments market received a boost in new instrument sales. While growth from the environmental market has slowed considerably since, the total market is still quite significant.

You have purchased a new gas chromatograph. Your company's safety office has completed a review of your lab's supplies. Before setting up your gas chromatograph, you read the instructions and familiarize yourself with the instrument. You might even give some thought to the exposure risks for the various substances in your samples. Yet, what about the less visible risks inherent in the gas delivery system that makes this a gas chromatograph?