新霉胺原料药的制备工艺及质量分析-preparation process and quality analysis of neomycoamine bulk drug.docxVIP

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新霉胺原料药的制备工艺及质量分析-preparation process and quality analysis of neomycoamine bulk drug.docx

新霉胺原料药的制备工艺及质量分析-preparation process and quality analysis of neomycoamine bulk drug

1.1外观、颜色与臭………………………………………………………………………371.2引湿性…………………………………………………………………………………371.3溶解度…………………………………………………………………………………371.4熔点或熔距……………………………………………………………………………371.5旋光度或比旋度………………………………………………………………………382.新霉胺原料药的鉴别……………………………………………………………………382.1化学反应鉴别法………………………………………………………………………382.2色谱鉴别法……………………………………………………………………………382.3红外光谱鉴别法………………………………………………………………………393.新霉胺原料药的检查……………………………………………………………………403.1一般杂质检查…………………………………………………………………………403.2溶液的澄清度与颜色，溶液的酸碱度………………………………………………423.3干燥失重………………………………………………………………………………433.4有关物质………………………………………………………………………………434.新霉胺原料药的含量测定………………………………………………………………444.1色谱条件……………………

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新霉胺原料药的制备工艺及质量分析-preparation process and quality analysis of neomycoamine bulk drug.docxVIP