产品基本情况介绍
产品优点:
•惰性物质，高纯度，洁白
•吸湿性低 •理化性质稳定
•多种标准系列型号和可按客户需求定制
•研磨和过筛工艺(可提供快速流动的产品)
•高结晶度
用途：乳糖可以满足理想辅料的多方面标准。其化学性质和物理性质相比与其他辅料和活性成分惰性更强。作为在世界范围内可供应的原料，乳糖具有良好品行，易于存储，物有所值，批此间的差异也极小。它既适合用于湿法制粒，也适合用于直接压片。通常，结晶级别的乳糖被用于湿法制粒，喷雾干燥形态的乳糖被用于直接压片。
产品规格:
用途 | 种类 | 粒度规格 | 其它 |
服制剂用 | 一水乳糖 | 80-200目 | (可定制） |
喷雾干燥乳糖 | -- | -- | -- |
无水乳糖 | -- | -- |
|
注射吸入用 | 供注射剂用乳糖 | -- | 合同定 |
产品标准：中国药典2015年版
包装： 25公斤/桶/袋
中国药典2015年版 | |
检验项目 | 标准规定 |
性状 | 白色结晶性颗粒或粉末；无臭、味微甜。在水中易溶，在乙醇、三氯甲烷或乙醚中不溶。 |
比旋度 | 应为+ 52.0° 至+52.6。 |
鉴别
| 1、应呈正反应 |
2、应符合规定 | |
3、应符合规定 | |
酸度 | 4.0-7.0 |
溶液的澄清度与颜色 | 应符合规定 |
有关物质 | 应符合规定 |
杂质吸光度
| 400nm ; A≤0.04 |
270-300nm ; A≤0.07 | |
210-220nm ; A≤0.25 | |
蛋白质 | 不得生成絮状沉淀 |
干燥失重 | 应不得过1.0% |
水分 | 4.5%～5.5% |
炽灼残渣 | 应不得过0.1% |
重金属 | 应不得过百万分之五 |
砷盐 | 应不得过百万分之二 |
含量 | 98.0%-102.0% (按无水物计） |
微生物限度 | 需氧菌总数≤l000cfu/g |
霉菌和酵母菌总数≤100 cfu /g | |
大肠埃希菌不得检出 | |
我公司产品优势：
国内最早生产药用乳糖
丰富的原料药生产经验
先进的生产设施
优良的客户口碑
Shandong Jinyang Pharmaceutical Co.,ltd, (Here after refered as JINYANG) is a large comprehensive high-tech private company which specializes in production and development of Active Pharmaceutical Ingredients, Enzymes, Biological Pharmaceutical Intermediates, Raw Material of Health products and Food additives. There are three full-owned entities and two joint stock companies, including Shanghai Huamao Pharmaceutical Co.,ltd; Binzhou Jinlang Pharmaceutical Co., ltd; Shandong Jinyang Biological Pharmaceutical Co.,ltd, B.Braun (Shandong) Pharmaceutical Co.,ltd and Rizhao Jiantong Gas Co.,ltd. Now, JINYANG owns five production bases occupied a SQM of 250,000 of covered area. In 2009, JINYANG has been awarded the title of “SHANDONG HIGH-TECH ENTERPRISES”.
Shandong Jinyang Biological Pharmaceutical Co.,ltd is one of the most professional veterinary medicine manufacturer in China, whoes orientation is the development, manufacturing, sale and technical service of High-tech veterinary new products and new dosage. Its comprehensive power lies within the top 10 of China animal’s nutrition and health manufacturers, and the yearly sales figure is above 10 million USD.
The company has the employees of above 100, including 60% of various kinds of technical staff. It covers the total floor areas of 24500 square meters, including large/Small volume Injections, Powder, Tablets, Powder for injection, Oral solution, Traditional Chinese Herba Powders, Premix, Disinfectant (Liquid), etc. Workshops. All dosages have passed the third time GMP inspection carried by the Ministray of Agriculture, China in Aug, 2014. Currently, the company’s major products include Penicillin-strep Suspension, Oxytetracycline long acting injection, Ivermectin injection, Albendazole oral solution, Multivitamin injection, etc. The products have passed the quality certificate of different countries, and far sold to more than 20 countries and regions in the world.
Moreover, the company can produce Injection, Emulsion, Oral solution, Tablets, etc. of different contents, specifications and packings according to customer’s requirement.
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