Bilastine is a second-generation antihistamine used to treat allergic conditions such as allergic rhinitis and chronic urticaria. It is marketed under various brand names including Blexten, Bilaz, and Bilastig. Bilastine works by selectively blocking histamine H₁ receptors, providing relief from symptoms like sneezing, itching, runny nose, and hives. To ensure its safety, efficacy, and quality, Bilastine must meet established pharmacopoeial standards such as those outlined in the Ph. Eur., USP, or IP. These standards are essential for confirming the drug’s identity, purity, potency, and consistency. Analytical standards typically include identification by IR or HPLC, assay for content determination, impurity profiling, and physical tests such as loss on drying. These measures help maintain batch-to-batch consistency and regulatory compliance.Analytical Standards of Bilastine Impurities are listed below.
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2-(4-(2-(4-(1-(2-Ethoxyethyl)-1H-benzo[d]imidazol-2-yl)piperidin-1-yl)ethyl)phenyl)-N-(1-hydroxy-2-methylpropan-2-yl)-2-methylpropanamide, Bilastine A...More Detail
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2-(4-(2-(4-(1-(2-hydroxyethyl)-1H-benzo[d]imidazol-2-yl)piperidin-1-yl)ethyl)phenyl)-2-methylpropanoic acid
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Bilastine Impurity 12 Bilastine Impurity F 2-(3-(2-(4-(1-(2-Ethoxyethyl)-1H-benzo[d]imidazol-2-yl)piperidin-1-yl)ethyl)phenyl)-2-methylpropanoic acid
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2-(4-(2-(4-(1-(4-(2-carboxypropan-2-yl)phenethyl)-1H-benzo[d]imidazol-2-yl)piperidin-1-yl)ethyl)phenyl)-2-methylpropanoic acid
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2-(2-(4-(2-(4-(1-(2-ethoxyethyl)-1H-benzo[d]imidazol-2-yl)piperidin-1-yl)ethyl)phenyl)propan-2-yl)-4, 4-dimethyl-4, 5-dihydrooxazole
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4-[2-[4-[1-(2-Methoxyethyl)-1H-benzimidazol-2-yl]-1-piperidinyl]ethyl]-α,α-dimethylbenzeneacetic Acid;
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Butyl2-(4-(2-(4-(1-(2-ethoxyethyl)-1H-benzo[d]imidazol-2-yl)piperidin-1-yl)ethyl)phenyl)-2-methylpropanoate
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Bilastine Methyl Ester, Methyl 2-(4-(2-(4-(1-(2-ethoxyethyl)-1H-benzo[d]imidazol-2-yl)piperidin-1-yl)ethyl)phenyl)-2-methylpropanoate
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1-(4-(2-Carboxypropan-2-yl)phenethyl)-4-(1-(2-ethoxyethyl)-1H-benzo[d]imidazol-2-yl)piperidine 1-Oxide, Bilastine N-Oxide