Synthesis and standardization of an impurity of acetaminophen, development and validation of liquid chromatographic method

Arıkan, Cemil Caner; Kulabaş, Necla; Küçükgüzel, İlkay

doi:10.1016/j.jpba.2022.115123

Journal of Pharmaceutical and Biomedical Analysis

2023

DOI: 10.1016/j.jpba.2022.115123

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Synthesis and standardization of an impurity of acetaminophen, development and validation of liquid chromatographic method

Cemil Caner Arıkan

Necla Kulabaş

İlkay Küçükgüzel

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Cited by 5 publications

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References 16 publications

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“…According to literature, 3,3′-dichlorobenzidine and 3,3′-dimethylbiphenyl-4,4′-diamine are usual impurities during the manufacturing process of DAB. [16][17][18] In this work, the influence of 3,3′-dichlorobenzidine and 3,3′-dimethylbiphenyl-4,4′-diamine on the synthesis of m-PBI was studied. The molecular weight, thermal stability of PBI, the mechanical strength, oxidation stability and proton conductivity of H 3 PO 4 /PBI membrane, and the performance of HT-PEMFCs were systematically studied.…”

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confidence: 99%

Study on Synthesis of Polybenzimidazole (PBI) Using Low Cost & High Impurity Industrial 3,3'-diaminobenzidine (DAB) for Application in High Temperature Proton Exchange Membrane Fuel Cells

Liu

et al. 2023

J. Electrochem. Soc.

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Poly[2,2-(m-phenylene)-5,5-bibenzimidazole] (m-PBI), the most studied PBI, is close to practical application; however, the high cost of m-PBI restricts its application for HT-PEMFCs. The cost can be reduced by 85% if the low-cost and high-impurity industrial DAB can be used to synthesize m-PBI after pre-treatment. Herein, we study the influence of impurities in industrial 3,3'-diaminobenzidine (DAB) on the synthesis of polybenzimidazole (PBI), and the possibility of the synthesis of m-PBI based on purified low-cost and high-impurity industrial DAB. It is shown that impurities would reduce the molecular weight and thermal stability of PBI, and mechanical strength and oxidation stability of the according PBI and H3PO4/PBI membranes. Using industrial DAB (94.40%) without any treatment as a reactant, the molecular weight of the obtained PBI is too low to prepare a membrane. A simple method of purifying low-cost and high-impurity industrial DAB is proposed, by dissolution and recrystallization using the absorption effect of carbon powder. It is proven that the performances of PBI synthesized using purified DAB are near to the PBI synthesized using high-purity DAB. The peak power density of HT-PEMFC based on PBI from purified industrial DAB reached 426 mW/cm2 at 180℃.

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confidence: 99%

Study on Synthesis of Polybenzimidazole (PBI) Using Low Cost & High Impurity Industrial 3,3'-diaminobenzidine (DAB) for Application in High Temperature Proton Exchange Membrane Fuel Cells

Liu

et al. 2023

J. Electrochem. Soc.

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Advances of hyphenated technique in impurity profiling of active pharmaceutical ingredients and pharmaceutical products

Khandale,

Rajge,

Singh

et al. 2023

Separation Science Plus

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Impurities found in active pharmaceutical ingredients (APIs) and pharmaceutical products are of ever‐increasing interest. According to several regulatory agencies, purity and impurity profiles are essential. An impurity is defined as any additional inorganic or organic material, residual solvents other than the medicinal components, or undesired compounds that remain with APIs. Impurities and degradation products in bulk drug materials and pharmaceutical formulations are identified, their structures are clarified, and their quantitative determination is part of impurity profiling. Unrecognized, poisonous impurities are dangerous to health and should be identified by selective procedures to increase the safety of drug therapy, and impurity profiling has become more significant in pharmaceutical analysis. This review briefly introduces process and product‐related impurities and emphasizes the creation of cutting‐edge analytical techniques for identifying them. It discusses the use of analytical methods, particularly high‐performance thin‐layer chromatography, liquid chromatography with mass spectrometry (MS), ultrahigh‐performance liquid chromatography, gas chromatography–MS, and nuclear magnetic resonance spectroscopy for the identification of contaminants and degradation products. It has discussed the importance of the quality, efficacy, and safety of drug substances and products, including the origin, types, and quality control of impurities, the need for the development of impurity profiling methods, impurity identification, and regulatory aspects.

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Isolation, synthesis and identification of degraded impurities in Letermovir

Chai,

Zhang,

Cai

et al. 2023

Journal of Pharmaceutical and Biomedical Analysis

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Synthesis and standardization of an impurity of acetaminophen, development and validation of liquid chromatographic method

Cited by 5 publications

References 16 publications

Study on Synthesis of Polybenzimidazole (PBI) Using Low Cost & High Impurity Industrial 3,3'-diaminobenzidine (DAB) for Application in High Temperature Proton Exchange Membrane Fuel Cells

Study on Synthesis of Polybenzimidazole (PBI) Using Low Cost & High Impurity Industrial 3,3'-diaminobenzidine (DAB) for Application in High Temperature Proton Exchange Membrane Fuel Cells

Advances of hyphenated technique in impurity profiling of active pharmaceutical ingredients and pharmaceutical products

Isolation, synthesis and identification of degraded impurities in Letermovir

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