Organic Impurity Profiling of Carbamazepine by HPLC/UV

来源 :第2届大连国际色谱学术报告会、第37届国际高效液相色谱及相关技术会议、第18届全国色谱学术报告会 | 被引量 : 0次 | 上传用户:maozi100
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  Carbamazepine is a medication indicated for use in epilepsy, trigeminal neuralgia and bipolar disorder.1 This widely prescribed tricyclic anticonvulsant is administered orally in usual doses of 400-1200 mg/day and is available in several commercial tablet, capsule and suspension forms.1 Synthesis-related organic impurities are usually present in bulk forms as well as in pharmaceutical formulations of carbamazepine.Pharmacopoeias set strict standards for the purity of carbamazepine to ensure drug efficacy and safety.The United States Pharmacopeia (USP) establishes 0.2% as the maximum limit for any individual impurity and 0.5% as the total of all impurities relative to the active pharmaceutical ingredient.
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