Identification and Structural Characterization of Unidentified Impurity in Bisoprolol Film-Coated Tablets

Mitrevska, Ivana; Kikovska-Stojanovska, E.; Petruševski, Gjorgji; Chachorovska, Marina; Memed-Sejfulah, Suzan; Ugarković, Sonja

doi:10.1155/2017/3047517

Cited by 6 publications

(3 citation statements)

References 14 publications

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“…To exemplify the complexity of such procedures, we mention the effort of a team of researchers from Alkaloid AD Skopje, Macedonia, to identify and characterize Impurity RRT 0.95 [22]. In this case, the selective beta 1 blocker Bisoprolol was contaminated with an unidentified impurity referred to as Impurity RRT 0.95.…”

Section: Separation and Isolation Methodsmentioning

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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Section: Separation and Isolation Methodsmentioning

confidence: 99%

Chemical Impurities: An Epistemological Riddle with Serious Side Effects

Abdin

Yeboah

Jacob

2020

IJERPH

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“…The impurity of relative retention time gives at 0.95 was observed in the stress thermal degradation study of the BF film-coated tablets with identification, characterization and quantitation was performed using HPLC/DAD/ESI-MS method. The configuration of the embattled Impurity RRT 0.95 was shown in Table 6 with molecular mass of BF were 406 [71].…”

Section: Number Of Impurity Structure Of Impuritiesmentioning

confidence: 99%

An Insight on Analytical Profile on Bisoprolol Fumarate – A Selective Beta-1 Adrenoreceptor Blocker

Dhandar

Chaudhari

Ganorkar

et al. 2017

JPTRM

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BF is Beta-adreno receptor antagonist and used as an AntiHypertensive Drug. BF gives the blocking action on β1-adrenergic receptors in the heart and vascular smooth muscle. The present review compiles the various approaches implemented for quantification of BF in bulk drug, pharmaceutical matrix and biological fluid. This review represents more than 50 analytical methods which include capillary electrophoresis, HPLC, HPTLC, UV-Spectroscopy, UPLC, impurity profiling and electrochemical methods implemented for estimation of BF as a single component as well as in multicomponent.

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“…The identified degradation product/impurity was concluded to be a product derived from the interaction of Bisoprolol fumarate with an excipient present that was calcium hydrogen phosphate. 11 Some studies conducted on Bisoprolol fumarate corresponds to the analytical method development.…”

Section: Introductionmentioning

confidence: 99%

Spectroscopic Substantiation for the Identification of Degradants by Q-TOF Micromass (ESI-MS) in Bisoprolol Fumarate with an Inventive Validation Approach for Stability Indicating HPLC Method

Pandey¹,

Pandey²,

Shukla³

2022

IJPER

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Background: Stability studies, stress testing of drug substances and finished drug product is obligatory due to the guidelines by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and other Regulatory Authorities. Materials and Methods: In the present work the selective Beta-1 receptor blocker, Bisoprolol fumarate was subjected to the forced degradation studies which includes hydrolysis (acidic, basic and neutral), oxidative, photolytic and thermal degradation. The drug was stable under light and basic and neutral medium. Results: The major findings in the presented work are the degradation products formed in the course of thermal degradation. The complete thermal degradation products were identified by High Performance Liquid Chromatography, Quadrupole-Time of Flight micromass (Electronspray Ionization-Mass Spectroscopy). The chromatographic conditions opted for the study includes Cosmosil C -18 column (4.6ID*250mm) with mobile phase consisting of methanol: phosphate buffer (pH 3.5 adjusted with orthophosphoric acid): Acetonitrile (45:35:20). Conclusion: The stability indicating method was validated as per the International Conference on Harmonization guidelines. The use of superior statistical tools for validation ensures the efficiency, quality and reproducibility of the presented method. Results obtained were agreeable and ensured the quality and reproducibility of the method.

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Identification and Structural Characterization of Unidentified Impurity in Bisoprolol Film-Coated Tablets

Cited by 6 publications

References 14 publications

Chemical Impurities: An Epistemological Riddle with Serious Side Effects

Chemical Impurities: An Epistemological Riddle with Serious Side Effects

An Insight on Analytical Profile on Bisoprolol Fumarate – A Selective Beta-1 Adrenoreceptor Blocker

Spectroscopic Substantiation for the Identification of Degradants by Q-TOF Micromass (ESI-MS) in Bisoprolol Fumarate with an Inventive Validation Approach for Stability Indicating HPLC Method

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