Detection and quantification of low-molecular-weight aldehydes in pharmaceutical excipients by headspace gas chromatography

Zhong, Li; Jacobus, Laura K.; Wuelfing, W. Peter; Golden, Mary; Martin, Gregory P.; Reed, Robert A.

doi:10.1016/j.chroma.2005.10.084

Cited by 60 publications

(28 citation statements)

References 14 publications

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“…3C). Salting-out reduces sample matrix effects and therefore improves method accuracy, while the equilibration time in the headspace vial is shortened (Li et al, 2006). Maximum sensitivity was achieved with the split/splitless injection port in splitless mode.…”

Section: Resultsmentioning

confidence: 91%

Acrolein Dimer as a Marker for Direct Detection of Acrolein in Wine

Bauer

Hiten

Crouch

et al. 2016

SAJEV

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Acrolein is highly toxic and its presence in wine has been correlated with the development of bitterness. Analytical detection and quantification in aqueous solutions are challenging due to high reactivity and problems with chemical derivative analysis. Here we demonstrate the potential of a natural derivative, formed under conditions prevailing in wine, as a marker for acrolein detection. Solid-phase microextraction (SPME) coupled with gas chromatograph mass spectrometry (GC-MS) was validated as a technique for direct detection of the acrolein dimer. Conventional GC-MS analysis using a quadrupole mass spectrometer did not provide sufficient chromatographic resolution for the separation of the target analyte from interfering compounds. Accurate mass measurements with time-of-flight (TOF)-MS, on the other hand, allowed qualitative and quantitative measurements of the acrolein dimer. This work lays the analytical foundation for studies on the evolution of acrolein and its dimer in solution.

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Section: Resultsmentioning

confidence: 91%

Acrolein Dimer as a Marker for Direct Detection of Acrolein in Wine

Bauer

Hiten

Crouch

et al. 2016

SAJEV

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“…Unfortunately reactivity may also be enhanced by the presence of other compounds (e.g. water in wet granulation, aldehyde groups in excipients (1) or by changed physicalchemical states (e.g. as an effect of drying and tableting).…”

Section: Introductionmentioning

confidence: 98%

Lactose Contaminant as Steroid Degradation Enhancer

Nieuwmeyer¹,

Maarschalk

Vromans

2008

Pharm Res

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“…Benzyl acetal, a condensation product of benzyl alcohol and benzaldehyde, is also considered to be a toxic impurity formed by oxidation [18]. While studies on compatibility to prevent API-excipient interactions and PAT technologies for quantifying impurities have been published elsewhere [19,20], very limited work has been performed on the use processes, i.e., how to manage the storage and testing of excipients.…”

Section: Introductionmentioning

confidence: 99%

Multiobjective Design Method for the Use Processes of Pharmaceutical Excipients Considering Quality and Cost-Effectiveness

et al. 2015

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Purpose Achieving cost-effectiveness while maintaining strict quality regulations is an emerging topic in pharmaceutical manufacturing. With a focus on the use process of excipients, e.g., reception, storage, testing, and actual usage, this paper presents a multiobjective design method for determining the optimal process setup. Method The method consists of setup of the problem, creation of models for quality and economic evaluation, and finally multiobjective optimization. A case study was performed using benzyl alcohol, an oxidation-sensitive material; we designated the amount of oxidized impurities and the costs associated with testing as the quality and economic objectives, respectively. The process was simulated, considering container volume and purchase frequency as the design variables, and also the use of Raman spectroscopy as an alternative to conventional identification testing. Results The multiobjective evaluation indicated options on the Pareto frontier, i.e., the set of non-dominant options. Here, the process with larger containers and less frequent purchases resulted in reduced testing costs but more impurities and vice versa for the opposite combination. The use of Raman spectroscopy was more effective in reducing the cost of identification testing than in preventing the degree of oxidation by not opening the container. Conclusions Through the case study, we showed that the method was capable of identifying the promising process settings, especially with the aid of graphical analysis on the Pareto frontier. The method, which is currently focused on excipients, could be extended to similar design cases using raw materials for pharmaceutical manufacturing.

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Detection and quantification of low-molecular-weight aldehydes in pharmaceutical excipients by headspace gas chromatography

Cited by 60 publications

References 14 publications

Acrolein Dimer as a Marker for Direct Detection of Acrolein in Wine

Acrolein Dimer as a Marker for Direct Detection of Acrolein in Wine

Lactose Contaminant as Steroid Degradation Enhancer

Multiobjective Design Method for the Use Processes of Pharmaceutical Excipients Considering Quality and Cost-Effectiveness

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