原輔料質(zhì)量標(biāo)準(zhǔn)

1、1原輔料質(zhì)量標(biāo)準(zhǔn)B.ZL.BZ.YF.00.001青霉素鉀原料質(zhì)量標(biāo)準(zhǔn)..............................................................3B.ZL.BZ.YF.00.002硫酸鏈霉素原料質(zhì)量標(biāo)準(zhǔn)..........................................................6B.ZL.BZ.YF.00.003磺胺間甲氧嘧啶鈉原料質(zhì)量標(biāo)準(zhǔn)....

2、..........................................9B.ZL.BZ.YF.00.004煙酸諾氟沙星原料質(zhì)量標(biāo)準(zhǔn)....................................................10B.ZL.BZ.YF.00.005磺胺嘧啶鈉原料質(zhì)量標(biāo)準(zhǔn)........................................................12B.ZL.BZ.

3、YF.00.006氟苯尼考原料質(zhì)量標(biāo)準(zhǔn)............................................................14B.ZL.BZ.YF.00.007鹽酸多西環(huán)素原料質(zhì)量標(biāo)準(zhǔn)....................................................16B.ZL.BZ.YF.00.008喹乙醇原料質(zhì)量標(biāo)準(zhǔn)..............................

4、..................................18B.ZL.BZ.YF.00.009白頭翁原料質(zhì)量標(biāo)準(zhǔn)................................................................20B.ZL.BZ.YF.00.010黃連原料質(zhì)量標(biāo)準(zhǔn)...................................................................

5、22B.ZL.BZ.YF.00.011黃柏原料質(zhì)量標(biāo)準(zhǔn)....................................................................25B.ZL.BZ.YF.00.012秦皮原料質(zhì)量標(biāo)準(zhǔn)....................................................................28B.ZL.BZ.YF.00.013板藍(lán)根原料質(zhì)量標(biāo)準(zhǔn)..

6、..............................................................30B.ZL.BZ.YF.00.014黃芪原料質(zhì)量標(biāo)準(zhǔn)....................................................................32B.ZL.BZ.YF.00.015淫羊藿原料質(zhì)量標(biāo)準(zhǔn)...................................

7、.............................35B.ZL.BZ.YF.00.016聚維酮碘原料質(zhì)量標(biāo)準(zhǔn)............................................................38B.ZL.BZ.YF.00.017硫酸卡那霉素原料質(zhì)量標(biāo)準(zhǔn)....................................................40B.ZL.BZ.YF.00.018

8、鹽酸土霉素原料質(zhì)量標(biāo)準(zhǔn)........................................................42B.ZL.BZ.YF.00.019酒石酸泰樂菌素原料質(zhì)量標(biāo)準(zhǔn)................................................44B.ZL.BZ.YF.00.020鹽酸大觀霉素原料質(zhì)量標(biāo)準(zhǔn)..........................................

9、..........46B.ZL.BZ.YF.00.021鹽酸林可霉素原料質(zhì)量標(biāo)準(zhǔn)....................................................48B.ZL.BZ.YF.00.022氧氟沙星原料質(zhì)量標(biāo)準(zhǔn)............................................................50B.ZL.BZ.YF.00.023硫酸慶大霉素原料質(zhì)量標(biāo)準(zhǔn).......

10、.............................................52B.ZL.BZ.YF.00.024甲氧芐啶原料質(zhì)量標(biāo)準(zhǔn)............................................................54B.ZL.BZ.YF.00.025地塞米松磷酸鈉原料質(zhì)量標(biāo)準(zhǔn)................................................56B.ZL

11、.BZ.YF.00.026替米考星原料質(zhì)量標(biāo)準(zhǔn)............................................................59B.ZL.BZ.YF.00.027鹽酸沙拉沙星原料質(zhì)量標(biāo)準(zhǔn)....................................................61B.ZL.BZ.YF.00.028甲磺酸達(dá)氟沙星原料質(zhì)量標(biāo)準(zhǔn)......................

12、..........................63B.ZL.BZ.YF.00.029阿莫西林原料質(zhì)量標(biāo)準(zhǔn)............................................................65B.ZL.BZ.YF.00.030克拉維酸鉀原料質(zhì)量標(biāo)準(zhǔn)........................................................68B.ZL.BZ.YF.00.031

13、磷酸泰樂菌素原料質(zhì)量標(biāo)準(zhǔn)....................................................70B.ZL.BZ.YF.00.032延胡索酸泰妙菌素原料質(zhì)量標(biāo)準(zhǔn)............................................72B.ZL.BZ.YF.00.033伊維菌素原料質(zhì)量標(biāo)準(zhǔn)..................................................

14、..........74B.ZL.BZ.YF.00.034雄黃原料質(zhì)量標(biāo)準(zhǔn)....................................................................76B.ZL.BZ.YF.00.035藿香原料質(zhì)量標(biāo)準(zhǔn)....................................................................78B.ZL.BZ.YF.00.036滑

15、石原料質(zhì)量標(biāo)準(zhǔn)....................................................................79B.ZL.BZ.YF.00.037黃芩原料質(zhì)量標(biāo)準(zhǔn)....................................................................80B.ZL.BZ.YF.00.038梔子原料質(zhì)量標(biāo)準(zhǔn).......................

16、.............................................82B.ZL.BZ.YF.00.039葶藶子原料質(zhì)量標(biāo)準(zhǔn)…………………………………………84B.ZL.BZ.YF.00.040浙貝母原料質(zhì)量標(biāo)準(zhǔn)…………………………………………86B.ZL.BZ.YF.00.041桔梗原料質(zhì)量標(biāo)準(zhǔn)……………………………………………88B.ZL.BZ.YF.00.042麻黃原料質(zhì)量標(biāo)準(zhǔn)…………………………………………

17、…903湖南省凱邦生物科技有限公司GMP管理文件題目青霉素鉀原料質(zhì)量標(biāo)準(zhǔn)編碼：B.ZL.BZ.YF.00.001共3頁制定審核批準(zhǔn)制定日期審核日期批準(zhǔn)日期頒發(fā)部門GMP辦頒發(fā)數(shù)量2份生效日期分發(fā)部門辦公室、質(zhì)控部引自標(biāo)準(zhǔn)：《中華人民共和國獸藥典》2010版一部121頁一、目一、目的：制定青霉素鉀原料質(zhì)量標(biāo)準(zhǔn)，規(guī)范公司青霉素鉀原料的采購、檢驗(yàn)、使用。二、適用范圍二、適用范圍：適用于青霉素鉀原料的檢驗(yàn)。三、責(zé)三、責(zé)任者：者：物料供應(yīng)部采購員

18、、倉庫保管員、質(zhì)控部。四、正四、正文：文：青霉素鉀青霉素鉀QingmeisujiaBenzylpenicillinBenzylpenicillinPotassiumPotassium本品為(2S，5R，6R)3，3二甲基6(2苯乙酰氨基)7氧代4硫雜1氮雜雙環(huán)[3.2.0]庚烷2甲酸鉀鹽。按無水物計(jì)算，含青霉素按Cl6H17KN2O4S計(jì)算，不得96.0%。【性狀性狀】本品為白色結(jié)晶性粉末；無臭或微有特異性臭；有引濕性；遇酸、堿或氧化劑