| 摘要: |
| 建立了盐酸林可霉素乳房注入剂（泌乳期）有关物质的检查方法。参考《中国兽药典》盐酸林可霉素注射液的含量测定色谱条件及有关物质限度范围，借鉴乳房注入剂含量测定的供试品提取方法，建立了有关物质检查方法，保证了方法的一致性和通用性。方法验证结果显示，本方法专属性较强，准确度和精密度符合要求，耐用性良好，适用于对盐酸林可霉素乳房注入剂进行有关物质检查，完善了标准对产品的质量控制功能，被收载入2020年版《中国兽药典》。 |
| 关键词: 盐酸林可霉素乳房注入剂(泌乳期) 有关物质 一致性 通用性 |
| DOI： |
| 投稿时间：2022-10-21修订日期：2022-12-19 |
| 基金项目:农业行业（国家）标准项目兽药国家标准制修订计划 |
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| Establishment of The Method for Examination of Related Substances in Lincomycin Hydrochloride Intramammary Infusion (Lactating Cow) |
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| (China Institute of Veterinary Drug Control) |
| Abstract: |
| A method for examination of related substances in lincomycin hydrochloride intramammary infusion (lactating cow) was established. With reference to the chromatographic conditions for the content determination and the limit range of related substances of lincomycin hydrochloride injection in Chinese Veterinary Pharmacopoeia, and with reference to the extraction method of the test sample for the content determination of lincomycin hydrochloride intramammary infusion, a method for examination of related substances in the preparation was established which ensured consistency and generality. The method validation results show that the method has strong specificity, high accuracy and precision, and good durability. It is suitable for examination of related substances in lincomycin hydrochloride intramammary infusion, and improves the quality control function of the standard. It was included in Chinese Veterinary Pharmacopoeia (2020). |
| Key words: Lincomycin hydrochloride intramammary infusion (lactating cow) examination of related substances consistency generality. |
