Therapeutic and Pharmaceutical Chemistry Laboratory, Pharmacy Department, University of Sidi Bel-Abbes, 22000 Algeria; Central Laboratory, University Hospital Center of Sidi Bel-Abbes, 22000, Algeria; Research in Pharmaceutical Development Laboratory, Pharmacovigilance Department, University Hospital Center 1st November, Oran University, 31000 Algeria; General Directorate of Scientific Research and Technological Development (DGRSDT), Algiers, Algeria.
Research in Pharmaceutical Development Laboratory, Pharmacovigilance Department, University Hospital Center 1st November, Oran University, 31000 Algeria; General Directorate of Scientific Research and Technological Development (DGRSDT), Algiers, Algeria.
Ann Pharm Fr. 2022 May;80(3):261-272. doi: 10.1016/j.pharma.2021.10.002. Epub 2021 Oct 20.
The medicine quality is defined by its aptitude to meet certain requirements declared by the regulatory authorities. Among these, impurities control which constitutes the major fear of pharmaceutical manufacturers in efficiency and safety terms. Nowadays, in many developing countries, the presence of poor quality drugs is common, for this reason, an increased control should be instituted including impurities which represent a serious public health problem threatening the efficacy and the safety medicines, because of their nocuous repercussions on health. The objective of this study is to verify that impurities in certain APIs: Ciprofloxacin, Metronidazole and Fluconazole actually collected on Algerian soil meet the impurity requirements.
An observational experimental study was carried out from 1st December 2013 to 31st December 2017, on impurities control in the APIs of Ciprofloxacin, Metronidazole and Fluconazole medicines registered in the Algerian Medicines Nomenclature and marketed in Algeria. All samples collected were analyzed to detect, quantify and evaluate impurties for rigorous control of three categories of impurties, such as: Organic related-impurities analysis by High-Pressure Liquid Chromatography with UV Detector (HPLC-UV), Elemental-impurities analysis by Inductively Coupled Plasma-Optical Emission Spectrometry (ICP-OES) and Residual Solvents-impurities analysis by Headspace Gas Chromatography with Flame Ionization Detection (HS-GC-FID).
18 samples collected from 11 laboratories among 27 requested. 22% of non-conformities were detected, including 5.5% Indian origin, 5.5% Spanish origin, 5.5% French origin and 5.5% Chinese origin. These non-conformity cases are due to the high rate of degradation product-impurity for C5 sample, Cobalt-impurity and Nickel-impurity contents exceeding the required limits for C4 and M3 samples respectively, Methanol-impurity and Toluene-impurity contents exceeding the authorized limits for M2 and F3 samples respectively.
This study concluded that samples non-compliance rate is high because of certain impurities detection exceeding the safety standards. So, we interpellate the health authorities to ensure the APIs impurities control before being put into the manufacturing process in order to prevent the potentially serious health problems that are difficult to control.
药品质量是由其满足监管机构规定的某些要求的能力来定义的。在这些要求中，杂质控制是制药商在效率和安全性方面的主要担忧。如今，在许多发展中国家，劣质药品的存在很常见，因此，应该加强控制，包括杂质控制，因为杂质对健康的有害影响是一个严重的公共卫生问题，威胁着药品的疗效和安全性。本研究的目的是验证在阿尔及利亚土壤中实际采集的某些 API 中的杂质：环丙沙星、甲硝唑和氟康唑是否符合杂质要求。
从 2013 年 12 月 1 日至 2017 年 12 月 31 日，进行了一项关于环丙沙星、甲硝唑和氟康唑药品 API 中杂质控制的观察性实验研究，这些药品在阿尔及利亚药品命名法中注册并在阿尔及利亚销售。对所有采集的样品进行分析，以检测、定量和评估三种杂质的杂质，如：有机相关杂质分析采用高压液相色谱法与紫外检测器（HPLC-UV）、元素杂质分析采用电感耦合等离子体-光学发射光谱法（ICP-OES）和残留溶剂-杂质分析采用顶空气相色谱法与火焰离子化检测（HS-GC-FID）。
从 27 个要求的实验室中收集了 18 个样品。检测到 22%的不合格品，包括 5.5%来自印度、5.5%来自西班牙、5.5%来自法国和 5.5%来自中国。这些不合格的原因是 C5 样品的降解产物-杂质的高比率、钴杂质和镍杂质的含量分别超过 C4 和 M3 样品的要求限值，甲醇杂质和甲苯杂质的含量分别超过 M2 和 F3 样品的授权限值。
本研究表明，由于某些杂质的检测超过了安全标准，因此样品不合格率很高。因此，我们呼吁卫生当局确保在制造过程中对原料药的杂质进行控制，以防止潜在的严重健康问题，这些问题难以控制。
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