蒲公英 - 制药技术的传播者 GMP理论的实践者

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作者: copperli    时间: 2015-3-6 14:34
厉害厉害厉害

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作者: 樱花草1234    时间: 2015-3-6 21:55
应该很不错

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作者: 清风化雨    时间: 2015-3-7 10:36
请求相助!

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作者: 清风化雨    时间: 2015-3-7 10:37
谢谢!!

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作者: dgtlyzh    时间: 2015-3-7 10:47
谢谢分享

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作者: whwyw    时间: 2015-3-7 11:24
学习学习

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作者: 明★    时间: 2015-3-7 11:50
xuexixuexi

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作者: haixuan    时间: 2015-3-7 16:06
制剂稳定性研究案例分析和技术要求

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作者: wbz5102    时间: 2015-3-8 15:54
谢谢楼主分享 学习一下

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作者: mhbjktl@126.com    时间: 2015-3-10 15:08
谢谢，分享

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作者: elroy2011    时间: 2015-3-10 19:16
学习学习了

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作者: 飘摇的杂草    时间: 2015-3-10 23:28
这么重要的东西，要好好学习下。

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作者: liuping9501    时间: 2015-3-11 14:17
想看看，谢谢啦！

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作者: yiyue118    时间: 2015-3-11 14:27
谢谢楼主分享

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作者: 799138061    时间: 2015-3-11 14:57
谢谢分享！

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作者: 北极的熊猫    时间: 2015-3-11 15:04
好好呀，O(∩_∩)O哈哈哈~

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作者: hmsqhs    时间: 2015-3-11 15:17
学习借鉴

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作者: limanzhen85    时间: 2015-3-12 11:21
学习探讨，期待进步

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作者: 开始懂了    时间: 2015-3-13 10:32
感谢分享，正在学习中

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作者: yanzhengren    时间: 2015-3-17 20:00
学习一个，谢谢

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作者: anaguaiguai    时间: 2015-3-17 22:05
学习学习

来自:Android客户端

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作者: 氧族元素    时间: 2015-3-18 09:07
学习一下，感谢分享

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作者: 温暖太阳花    时间: 2015-3-18 22:28
学习一下！

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作者: 五味子1977    时间: 2015-3-20 16:25
学习一下，感谢分享！

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作者: 昨夜风123    时间: 2015-3-21 13:27


Ceftriaxone Sodium
(sef'' trye ax' one soe' dee um).
Click to View Image
C18H16N8Na2O7S3·3½H2O 661.60

5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2-amino-4-thiazolyl)(methoxyimino)acetyl]amino]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5-, 6-dioxo-1,2,4-triazin-3-yl)thio]methyl]-, disodium salt, [6R-[6,7(Z)]]-, hydrate, (2:7).

(6R,7R)-7-[2-(2-Amino-4-thiazolyl)glyoxylamido]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-as-triazin-3-yl)thio]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 72-(Z)-(O-methyloxime), disodium salt, sesquaterhydrate [104376-79-6].

Anhydrous 598.56
» Ceftriaxone Sodium contains the equivalent of not less than 795 μg of ceftriaxone (C18H18N8O7S3) per mg, calculated on the anhydrous basis.
Packaging and storage— Preserve in tight containers.
Labeling— Where it is intended for use in preparing injectable dosage forms, the label states that it is sterile or must be subjected to further processing during the preparation of injectable dosage forms.
USP Reference standards 11—
USP Ceftriaxone Sodium RS
USP Ceftriaxone Sodium E-Isomer RS
USP Endotoxin RS
Identification—
A: Infrared Absorption 197K.
B: The chromatogram of the Assay preparation obtained as directed in the Assay exhibits a major peak for ceftriaxone, the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparation obtained as directed in the Assay.
C: It responds to the tests for Sodium 191.
Crystallinity 695: meets the requirements.
pH 791: between 6.0 and 8.0 in a solution (1 in 10).
Water, Method I 921: between 8.0% and 11.0%.
Other requirements— Where the label states that Ceftriaxone Sodium is sterile, it meets the requirements for Sterility and Bacterial endotoxins under Ceftriaxone for Injection. Where the label states that Ceftriaxone Sodium must be subjected to further processing during the preparation of injectable dosage forms, it meets the requirements for Bacterial endotoxins under Ceftriaxone for Injection.
Assay—
pH 7.0 Buffer— Dissolve 13.6 g of dibasic potassium phosphate and 4.0 g of monobasic potassium phosphate in water to obtain 1000 mL of solution. Adjust this solution with phosphoric acid or 10 N potassium hydroxide to a pH of 7.0 ± 0.1.
pH 5.0 Buffer— Dissolve 25.8 g of sodium citrate in 500 mL of water, adjust with citric acid solution (1 in 5) to a pH of 5.0 ± 0.1, and dilute with water to a volume of 1000 mL.
Mobile phase— Dissolve 3.2 g of tetraheptylammonium bromide in 400 mL of acetonitrile, add 44 mL of pH 7.0 Buffer and 4 mL of pH 5.0 Buffer, and add water to make 1000 mL. Filter through a membrane filter of 0.5 μm or finer porosity, and degas. Make adjustments if necessary (see System Suitability under Chromatography 621).
Standard preparation— Dissolve an accurately weighed quantity of USP Ceftriaxone Sodium RS in Mobile phase, to obtain a solution having a known concentration of about 0.2 mg per mL. Use this solution promptly after preparation.
Resolution solution— Dissolve a suitable quantity of USP Ceftriaxone Sodium E-Isomer RS in Standard preparation, and dilute with Mobile phase to obtain a solution containing about 160 μg of USP Ceftriaxone Sodium E-Isomer RS per mL and 160 μg of USP Ceftriaxone Sodium RS per mL. Use this solution promptly after preparation.
Assay preparation— Transfer about 40 mg of Ceftriaxone Sodium, accurately weighed, to a 200-mL volumetric flask, dissolve in and dilute with Mobile phase to volume, and mix. Use this solution promptly after preparation.
Chromatographic system (see Chromatography 621)—The liquid chromatograph is equipped with a 270-nm detector and a 4.0-mm × 15-cm column that contains 5-μm packing L1. The flow rate is about 2 mL per minute. Chromatograph the Resolution solution, and record the peak responses as directed under Procedure: the resolution, R, between the ceftriaxone E-isomer and ceftriaxone peaks is not less than 3. Chromatograph the Standard preparation, and record the peak responses as directed under Procedure: the column efficiency determined from the analyte peak is not less than 1500 theoretical plates; the tailing factor for the analyte peak is not more than 2; and the relative standard deviation for replicate injections is not more than 2%.
Procedure— Separately inject equal volumes (about 20 μL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in μg, of ceftriaxone (C18H18N8O7S3) per mg of the Ceftriaxone Sodium taken by the formula:
200(CP / W)(rU / rS)
in which C is the concentration, in mg per mL, of USP Ceftriaxone Sodium RS in the Standard preparation; P is the designated potency, in μg of ceftriaxone per mg, of USP Ceftriaxone Sodium RS; W is the quantity, in mg, of the Ceftriaxone Sodium taken to prepare the Assay preparation; and rU and rS are the ceftriaxone peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question        Contact        Expert Committee
Monograph        Ahalya Wise, M.S.
Senior Scientific Liaison
1-301-816-8161        (SM12010) Monographs - Small Molecules 1
Reference Standards        RS Technical Services
1-301-816-8129
rstech@usp.org       
USP35–NF30 Page 2576


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作者: mbl2006    时间: 2015-3-21 13:33
里面有具体的统计学内容么，这一块很重要

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作者: ld0371    时间: 2015-3-21 14:00
22222222222222222222222

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作者: hzh20027027    时间: 2015-3-21 14:03
多谢楼主分享

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作者: lx0003    时间: 2015-3-21 14:35
谢谢 楼主下载 学习

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作者: pharmyu    时间: 2015-3-23 09:42
谢谢分享！

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作者: annie456    时间: 2015-3-23 10:40
学习学习。。。。。

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作者: 喜之郎    时间: 2015-3-23 10:51
谢谢分享   

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作者: 苦涩de咖啡    时间: 2015-3-23 11:06
必须学习啊  

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作者: 北重楼    时间: 2015-3-23 11:10
什么时候培训的

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作者: shenweishaa    时间: 2015-3-23 11:12
好好学习学习.

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作者: 金素琴    时间: 2015-3-23 11:27
学习！！！！

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