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引用次数: 3
摘要
在药物化学领域,杂质被认为是存在于治疗活性药物化合物中的不需要的化学物质。它们的效力异常强大,预计会产生毒性;因此,它可能表现出意想不到的药理作用,对人体健康有害。杂质的控制是目前制药行业的一个关键问题。最可能的杂质来源是涉及各种步骤的合成,即从起始材料到通过中间步骤的成品。原料药和药品中的杂质是仿制药办公室的关键监管问题,对药品的可批准性有重大影响,因此国际统一会议(ICH)和食品药品监督管理局(FDA)指南通过使用各种分析技术,如TLC, LC, GC, MS, NMR, IR, UV, GC-MS, LC-MS, LC-NMR等,介绍了它们的鉴定和鉴定程序。
A Review on Pharmaceutical Impurities and its Importance in Pharmacy.
In the field of pharmaceutical chemistry, impurities are considered as unwanted chemicals that present in the therapeutically active pharmaceutical compounds. They are unusually potent and expected to produce toxicity; hence it may be shows unexpected pharmacological actions which are harmful to human health. The control of impurities is currently a critical issue to the pharmaceutical industry. The most possible source of impurities is the synthesis that involves various steps, i.e. from starting materials to finished products through the intermediate steps. Impurities in drug substances and drug products are key regulatory issues in the office of generic drugs and have significant impact on the approvability of drugs hence International Conference on Harmonization (ICH) and Food and Drug Administration (FDA) guidelines introduce the identification and qualification procedures for them, by using various analytical techniques like TLC, LC, GC, MS, NMR, IR, UV, GC-MS, LC-MS, LC-NMR etc,.