| 摘要: |
| 本试验借鉴了中国食品药品检定研究院阿莫西林系统适用性对照品制备工艺,在原工艺基础上进行了优化,增加了酸中和的关键步骤,研制了阿莫西林系统适用性国家兽药标准物质。通过工艺优化,显著提升了样品溶液稳定性；且与中检院的对照品对比,未知杂质明显减少,已知杂质均可清晰定位,尤其是阿莫西林闭环三聚体更易于辨识。本对照品的研制对阿莫西林原料及相关制剂的生产及质量控制具有重要意义。 |
| 关键词: 阿莫西林系统适用性国家兽药标准物质 酸中和 工艺优化 |
| DOI： |
| 投稿时间：2022-12-10修订日期：2023-05-15 |
| 基金项目:兽药行业公益性重点专项“兽用化学药品检验用部分标准物质研究” |
|
| Development of National Veterinary Drug Reference Substance for Amoxicillin System Suitability |
|
| (China Institute of Veterinary Drug Control) |
| Abstract: |
| The preparation process of amoxicillin system suitability reference substance of NIFDC was used for reference, the original process was optimized, and the key step of acid neutralization was added in order to develop national veterinary drug reference substance for amoxicillin system suitability. The stability of the sample solution was significantly improved through process optimization; In addition, compared with the reference substance of NIFDC, the unknown impurities are significantly reduced, and the known impurities could be clearly located, especially the amoxicillin trimer is easier to identify. The preparation of this reference substance is of great significance to the production and quality control of amoxicillin raw materials and related preparations. |
| Key words: national veterinary drug reference substance for amoxicillin system suitability acid neutralization process optimization |
