Critical review of reports on impurity and degradation product profiling in the last decade

Gǒrög, Sándor

doi:10.1016/j.trac.2017.09.012

Cited by 73 publications

(27 citation statements)

References 224 publications

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“…The determination of impurity profiles with well‐defined analytical methods has been widely and commonly used to qualify and quantify drug substances and formulations . For example, De Beer's group examined the differences in impurity profiles through HPLC‐UV to detect counterfeit and imitations of the erectile dysfunction drugs Viagra (sildenafil citrate) and Cialis (tadalafil), Cialis being a registered trademark of Eli Lilly and Company.…”

Section: Analytical Technologies For the Detection Of Pharmaceutical mentioning

confidence: 99%

“…[33,35] The determination of impurity profiles with well-defined analytical methods has been widely and commonly used to qualify and quantify drug substances and formulations. [36,37] For example, De Beer's group [38] examined the differences in impurity profiles through HPLC-UV to detect counterfeit and imitations of the erectile dysfunction drugs Viagra (sildenafil citrate) and Cialis (tadalafil), Cialis being a registered trademark of Eli Lilly and Company. They found an apparent difference between genuine samples and counterfeit drugs by chromatographic fingerprints, again illustrating the impurity profiles that obtained Chaobo Huang studied pharmaceutical sciences at Ghent University (Belgium) and graduated in 2011.…”

Section: Analytical Authentication Technologiesmentioning

confidence: 99%

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Materials and Technologies to Combat Counterfeiting of Pharmaceuticals: Current and Future Problem Tackling

et al. 2020

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The globalization of drug trade leads to the expansion of pharmaceutical counterfeiting. The immense threat of low quality drugs to millions of patients is considered to be an under‐addressed global health challenge. Analytical authentication technologies are the most effective methods to identify active pharmaceutical ingredients and impurities. However, most of these analytical testing techniques are expensive and need skilled personnel. To combat counterfeiting of drugs, the package of an increasing number of drugs is being protected through advanced package labeling technologies. Though, package labeling is only effective if the drugs are not repackaged. Therefore “in‐drug labeling,” instead of “drug package labeling,” may become powerful tools to protect drugs. This review aims to overview how advanced micro‐ and nanomaterials might become interesting markers for the labeling of tablets and capsules. Clearly, how well such identifiers can be integrated into “solid drugs” without compromising drug safety and efficacy remains a challenge. Also, incorporation of tags has so far only been reported for the protection of solid drug dosage forms. No doubts that in‐drug labeling technologies for “liquid drugs,” like injectables which contain expensive peptides, monoclonal antibodies, vaccines, dermal fillers, could help to protect them from counterfeiting as well.

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Section: Analytical Technologies For the Detection Of Pharmaceutical mentioning

confidence: 99%

Section: Analytical Authentication Technologiesmentioning

confidence: 99%

Materials and Technologies to Combat Counterfeiting of Pharmaceuticals: Current and Future Problem Tackling

et al. 2020

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“…Identifying and characterizing a certain impurity can be accomplished through different methods, depending largely on the amount of the impurity and its sensitivity to the analytical method applied [21]. Here, it is common to carry out a series of different analyses to achieve a sufficient characterization of the sample and identification of all hints for an impurity found in the sample, such as a spot on the thin layer chromatography (TLC) or a peak in the mass spectrum, often with the assistance of modern and automated methods of characterization.…”

Section: There Are Always Impuritiesmentioning

confidence: 99%

Chemical Impurities: An Epistemological Riddle with Serious Side Effects

Abdin

Yeboah

Jacob

2020

IJERPH

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Chemical synthesis is a science and an art. Rooted in laboratory or large-scale manufacture, it results in certain side products, eventually compromising the integrity of the final products. Such “impurities” occur in small amounts and, within chemistry itself, are of little concern. In pharmacy, in contrast, impurities increase the potential for toxicity, side effects, and serious implications for human health and the environment. The pharmaceutical regulatory agencies have therefore developed regulatory and strategic systems to minimize the chemical presence or biological impact of such substances. Here, pharmaceuticals are turned from impure into more defined materials as part of a complex socio-technological system revolving around and constantly evolving its specific rules and regulations. Whilst modern analytical methods indicate the presence of impurities, the interpretations of corresponding results are gated by risk management and agreed thresholds. Ironically, this allows for entities with no identified chemical structures, and hence epistemologically outside chemistry, to be regulated in pharmaceutical products. We will refer to such substances which are not, epistemologically speaking, “chemicals” as Xpurities, in order to distinguish them from recognized and identified impurities. The presence of such Xpurities is surprisingly common and constitutes a major issue in pharmaceutical research and practice. We propose a Space of Information to deal with such impurities based on values regarding the presence, chemical identities, and biological activities. It is anticipated that this may enable pharmacists to handle such Xpurities more efficiently.

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“…A lot of analytical techniques are used in order to assess the quality of drugs [2]. The most common method in the field of degradation product profiling is high-performance liquid chromatography (HPLC), coupled with ultraviolet/visible (UV/Vis) and/or mass spectrometric (MS) detectors.…”

Section: Introductionmentioning

confidence: 99%

A Deeper Investigation of Drug Degradation Mixtures Using a Combination of MS and NMR Data: Application to Indapamide

et al. 2019

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A global approach that is based on a combination of mass spectrometry (MS) and nuclear magnetic resonance (NMR) data has been developed for a complete and rapid understanding of drug degradation mixtures. We proposed a workflow based on a sample preparation protocol that is compatible to MS and NMR, the selection of the most appropriate experiments for each technique, and the implementation of prediction software and multivariable analysis method for a better interpretation and correlation of MS and NMR spectra. We have demonstrated the efficient quantification of the remaining active pharmaceutical ingredient (API). The unambiguous characterization of degradation products (DPs) was reached while using the potential of ion mobility-mass spectrometry (IM-MS) for fragment ions filtering (HDMSE) and the implementation of two-dimensional (2D) NMR experiments with the non-uniform sampling (NUS) method. We have demonstrated the potential of quantitative NMR (qNMR) for the estimation of low level DPs. Finally, in order to simultaneously monitor multi-samples, the contribution of partial least squares (PLS) regression was evaluated. Our methodology was tested on three indapamide forced degradation conditions (acidic, basic, and oxidative) and it could be easily transposed in the drug development field to assist in the interpretation of complex mixtures (stability studies, impurities profiling, and biotransformation screening).

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Critical review of reports on impurity and degradation product profiling in the last decade

Cited by 73 publications

References 224 publications

Materials and Technologies to Combat Counterfeiting of Pharmaceuticals: Current and Future Problem Tackling

Materials and Technologies to Combat Counterfeiting of Pharmaceuticals: Current and Future Problem Tackling

Chemical Impurities: An Epistemological Riddle with Serious Side Effects

A Deeper Investigation of Drug Degradation Mixtures Using a Combination of MS and NMR Data: Application to Indapamide

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