Quantitation of 5-hydroxymethylfurfural (5-HMF) and related substances in dextrose injections containing drugs and bisulfite

Hryncewicz, Cheryl L.; Koberda, Michael; Konkowski, Mary

doi:10.1016/0731-7085(95)01622-8

Cited by 14 publications

(5 citation statements)

References 8 publications

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“…This absorbance was found to originate from two main degradation products, identified as 5-hydroxymethylfurfural (HMF) and furfural (F) (Unpublished results). These are common degradation products of sugars [107,108]. Chemical pathways of sugar conversion to HMF are described in Fig.…”

Section: Excipient Stability Issuesmentioning

confidence: 99%

Development of Stable Lyophilized Protein Drug Products

Remmele¹,

Krishnan²,

Callahan³

2012

CPB

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Freeze drying, or lyophilization is widely used for biopharmaceuticals to improve the long term storage stability of labile molecules. This review examines general theory and practice of rational lyophilization of biopharmaceuticals. Formulation development involving the selection of appropriate excipients, their associated physical properties, and mechanism of action in achieving a stable drug product are primary considerations for a successful lyophilization program. There are several parameters considered critical on the basis of their relationship to lyophilization cycle development and protein product stability. This along with the importance of analytical methods to provide insight toward understanding properties of drug product stability and cake structure are discussed. Also, aspects of instability found in lyophilized biopharmaceutical products, their degradation pathways and control are elucidated. Finally, container-closure requirements and drug product handling are described in context of the caveats to avoid compromising drug product quality.

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Section: Excipient Stability Issuesmentioning

confidence: 99%

Development of Stable Lyophilized Protein Drug Products

Remmele¹,

Krishnan²,

Callahan³

2012

CPB

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“…HMF is considered as an indicator compound for the occurrence of 2,3-and 1,2-enolizations in solutions of reducing sugars and is recognised as an indicator of quality deterioration, as a result of excessive heating or storage in a wide range of foods [2,3,4] or in sterilised glucose solutions used for parenteral nutrition [5,6].…”

Section: Introductionmentioning

confidence: 99%

Analysis of 5‐hydroxymethylfurfual in coffee, dried fruits and urine

Murkovic¹,

Pichler

2006

Molecular Nutrition Food Res

160

102

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5-Hydroxymethylfurfural has become a substance of interest since recent results showed a possible carcinogenic potential in consequence of a metabolic activation by sulfotransferases. 5-Hydroxymethylfurfural is formed either by acid catalysed degradation of reducing sugars or via the Maillard reaction. This work provides an overview of foods potentially containing high amounts of 5-hydroxymethylfurfural. It comprises dried fruits with a high sugar content that were exposed to heat for a long time. The concentration ranges from very low in, e. g. figs (1 mg/kg) to plums that contained up to 2,200 mg/kg. Several types of roasted coffee were analysed that contained from 300 to 2,900 mg/kg of 5-hydroxymethylfurfural. In a small human study with seven healthy volunteers the urine excretion of unmetabolised 5-hydroxymethylfurfural was investigated. After uptake of 20 g of plum jam containing 24 mg of 5-hydroxymethylfurfural, 163 microg (mean) were excreted within 6 h, an equivalent of 0.75% of the ingested 5-hydroxymethylfurfural.

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“…However, quantification methods of 5‐HMF in the commercial injections were less reported. Hryncewicz et al . detected 5‐HMF and related substances in dextrose injections containing drugs and bisulfite by UV.…”

Section: Introductionmentioning

confidence: 99%

“…However, quantification methods of 5-HMF in the commercial injections were less reported. Hryncewicz et al [27] detected 5-HMF and related substances in dextrose injections containing drugs and bisulfite by UV. Xu et al [28] developed an anion exchange chromatography coupled with pulsed amperometric detection (AEC-PAD) to determine 5-HMF in commercial aqueous dextrose solutions.…”

Section: Introductionmentioning

confidence: 99%

An improved method for the determination of 5‐hydroxymethylfurfural in Shenfu injection by direct analysis in real time‐quadrupole time‐of‐flight mass spectrometry

Gao

Liu³

et al. 2015

Drug Testing and Analysis

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The emergence of direct analysis in real time (DART) ion source provides the great possibility for rapid analysis of hazardous substance in drugs. DART mass spectrometry (DART-MS) enabled the conducting of a fast and non-contact analysis of various samples, including solid or liquid ones, without complex sample preparation or chromatographic separation. In this study, a modified DART-quadrupole time-of-flight mass spectrometry (DART-QTOF-MS) method was developed for identification and determination of 5-hydroxymethylfurfural (5-HMF) in Shenfu (SF) injection. The quantitative transfer of sample solution was introduced to the glass tips of DIP-it sampler at a fixed volume, which significantly increases the repeatability and accuracy of analytical results. The protonated ion of dibutyl phthalate in the atmosphere was used as the reference mass for TOF-MS recalibration during the data acquisition for constant high accuracy mass measurements. Finally, the developed DART-MS method was used to determine 5-HMF in seven batches of SF injection, and the contents of 5-HMF were not higher than 100 µg/mL. The results obtained were further confirmed by an ultra-high performance liquid chromatography combined with triple quadrupole mass spectrometer (UHPLC-QQQ-MS). The overall results demonstrated that the DART-QTOF-MS method could be applied as an alternative technique for rapid monitoring 5-HMF in herbal medicine injection. Copyright © 2015 John Wiley & Sons, Ltd.

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Quantitation of 5-hydroxymethylfurfural (5-HMF) and related substances in dextrose injections containing drugs and bisulfite

Cited by 14 publications

References 8 publications

Development of Stable Lyophilized Protein Drug Products

Development of Stable Lyophilized Protein Drug Products

Analysis of 5‐hydroxymethylfurfual in coffee, dried fruits and urine

An improved method for the determination of 5‐hydroxymethylfurfural in Shenfu injection by direct analysis in real time‐quadrupole time‐of‐flight mass spectrometry

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