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氯霉素
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英文名: Chloramphenicol
CAS RN: 56-75-7
分子式: C11H12Cl2N2O5 分子量; 323.13
质量标准:CP2005/USP/BP
性 状: 白色、绿白色或黄白色微细针状,长片状结晶或结晶性粉末
溶解度:微溶于水,易溶于96%乙醇及丙二醇中,微溶于乙醚
含 量: 98.5-102% 氯化物≤100PPM
熔 点: 149-153℃ 旋光度 +18.5至+20.5°
干燥失重 ≤0.5% 硫酸灰份≤0.1%
用 途: 医药原料药,属抑菌性广谱抗生素药物
包 装: 25kg/纸板桶 1KG/铁听
湖北威德利化学科技有限公司主营原料药、医药中间体、精细化工、兽药等,是集生产销售于一体
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咨询厂家程先生 bbb: 027-83991130,18627774460 QQ1718093273
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项 目 bbbbbeter |
EP/BP 标准 Specification of EP/BP |
检验结果 Results | |||
性状 Appearance |
白色或微灰白色、黄白色结晶性粉末或针状结晶。 A white, greyish-white or yellowish-white, fine, crystalline powder or fine crystals, needles or elongated plates. |
微黄白色结晶性粉末 A yellowsh-white, fine crystalline powder, needles. |
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微溶于水,易溶于乙醇和丙二醇。本品溶于乙醇中的溶液为右旋,溶于醋酸乙酯中的溶液为左旋。Slightly soluble in water, freely soluble in alcohol and in propylene glycol. Its alcohol solution is dextrorotatory and its ethyl acetate solution is levorotatory. |
符合规定 Qualified |
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鉴别 Identification |
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熔程 Melting range |
Between 149℃ and 153℃ |
149.7~152.4℃ | |||
红外 Infrared absorption spectrophotometry |
红外图谱应与标准品图谱一致 IR spectrophotometry similar to which of Chloramphenicol CRS |
符合规定 Qualified |
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酸碱度 Acidity or alkalinity | 取本品0.1g,加20ml无二氧化碳的水,振摇,加0.1ml溴百里酚蓝溶液。指示剂变色时消耗不超过0.1ml 的0.02M盐酸或0.02M氢氧化钠. |
符合规定 Qualified |
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To 0.1 g add 20 ml of carbon dioxide-free water R, shake and add 0.1 ml of bromothymol blue solution R1. Not more than 0.1 ml of 0.02 M hydrochloric acid or 0.02 M sodium hydroxide is required to change the colour of the indicator. | |||||
比旋度 Specific optical rotation |
Between ﹢18.5º and ﹢20.5º | +19.4º | |||
有关物质 Related substances |
单一杂质量≤0.5% Individaul impurity≤0.5% | <0.5% | |||
氯化物 Chlorides |
≤0.01% | <0.01% | |||
干燥失重 Loss on drying |
≤0.3% | 0.09% | |||
硫酸盐灰分 Sulfated ash | ≤0.1% | 0.03% | |||
含量 Assay |
98.0% to 102.0% | 100.4% | |||
微生物限度 Microbial limit | 需氧菌总数 Total Aerobic Microbial Count | ≤10cfu/g | <10CFU/g | ||
霉菌和酵母菌数 Total Yeasts and Molds Count |
不得检出/g Absent per g |
未检出 Absent | |||
大肠埃希菌 Escherichia coli |
不得检出/g Absent per g |
未检出 Absent | |||
铜绿假单胞菌和金黄色葡萄球菌 Pseudomonas aeruginosa & staphylococcus aureus |
不得检出/g Absent per g |
未检出 Absent | |||
结论 Conclusion: |
本品符合EP/BP 标准。 The product complies toEP/BP . |