| 查看: 564 | 回复: 1 | |||
wh168ren木虫 (小有名气)
|
[求助]
盐酸利托君片质量标准
|
| 中检所进口药品复核标准(5)里的盐酸利托君片。有的麻烦传分，谢谢！ |
回复此楼» 猜你喜欢
274求调剂
已经有6人回复
-
0805总分292，求调剂
已经有7人回复
-
299求调剂
已经有5人回复
-
0856材料与化工，270求调剂
已经有3人回复
-
材料化工调剂
已经有11人回复
-
高分子化学与物理调剂
已经有12人回复
-
306分材料调剂
已经有5人回复
-
化工299分求调剂 一志愿985落榜
已经有5人回复
-
材料学硕318求调剂
已经有11人回复
-
0856化工专硕求调剂
已经有12人回复
» 本主题相关价值贴推荐，对您同样有帮助:
- 药丸（盐酸小檗碱片）溶化，衣服被染黄了，如何去除？
已经有17人回复
- 管通（盐酸米多君片）谁知道哪里有得卖！急求
已经有3人回复
- 盐酸利托君如何纯化成固体
已经有9人回复
- 请问盐酸四环素怎么配制
已经有4人回复
- 羟基磷灰石XRD标准谱图
已经有2人回复
- 【求助】HPLC测盐酸环丙沙星片该用流动相溶解吗？
已经有4人回复
- 【求助】求助：盐酸氨基葡萄糖片质量标注，小弟新手
已经有9人回复
- 【求助】卵磷脂的质量标准
已经有3人回复
070918
木虫 (著名写手)
- 应助: 58 (初中生)
- 金币: 4953.8
- 散金: 793
- 红花: 9
- 帖子: 1159
- 在线: 234.9小时
- 虫号: 661023
- 注册: 2008-11-24
- 性别: GG
- 专业: 药剂学
【答案】应助回帖
★ ★ ★
豆哥: 金币+2, 欢迎常来生产版交流学习~~~ 2012-09-21 14:34:19
wh168ren: 金币+1, ★有帮助, 谢谢，不过你发得是美国药典32上的标准。 2012-09-24 08:00:07
豆哥: 金币+2, 欢迎常来生产版交流学习~~~ 2012-09-21 14:34:19
wh168ren: 金币+1, ★有帮助, 谢谢，不过你发得是美国药典32上的标准。 2012-09-24 08:00:07
|
Ritodrine Hydrochloride Tablets » Ritodrine Hydrochloride Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C17H21NO3·HCl. Packaging and storage— Preserve in tight containers. Store at room temperature, preferably below 30. USP Reference standards 11— USP Ritodrine Hydrochloride RS. Identification— The retention time of the Tablets in the Assay preparation obtained in the Assay corresponds to that of the Standard preparation obtained in the Assay. Dissolution 711— Medium: 0.01 N hydrochloric acid; 900 mL. Apparatus 2: 50 rpm. Time: 30 minutes. Procedure— Determine the amount of C17H21NO3·HCl dissolved by employing the procedure set forth in the Assay, using a filtered portion of the solution under test as the Assay preparation in comparison with a Standard solution having a known concentration of USP Ritodrine Hydrochloride RS in the same Medium. Tolerances— Not less than 80% (Q) of the labeled amount of C17H21NO3·HCl is dissolved in 30 minutes. Uniformity of dosage units 905: meet the requirements. Procedure for content uniformity— Transfer 1 Tablet to a 200-mL volumetric flask, add about 5 mL of water, and stir until disintegration is complete. Add about 150 mL of methanolic sulfuric acid solution (0.005 M sulfuric acid in methanol), continue stirring for an additional 15 minutes, dilute with methanolic sulfuric acid solution to volume, and mix. Filter a portion of the mixture, discarding the first 20 mL of the filtrate. Dissolve an accurately weighed quantity of USP Ritodrine Hydrochloride RS in methanolic sulfuric acid solution, and dilute quantitatively and stepwise with the same solvent to obtain a Standard solution having a known concentration of about 50 µg per mL. Concomitantly determine the absorbances of both solutions in 1-cm cells at the wavelength of maximum absorbance at about 276 nm, with a suitable spectrophotometer, using methanolic sulfuric acid solution as the blank. Calculate the quantity, in mg, of C17H21NO3·HCl in the Tablet taken by the formula: (TC / D)(AU / AS) in which T is the labeled quantity, in mg, of ritodrine hydrochloride in the Tablet, C is the concentration, in µg per mL, of USP Ritodrine Hydrochloride RS in the Standard solution, D is the concentration, in µg per mL, of ritodrine hydrochloride in the solution from the Tablet based upon the labeled quantity per Tablet and the extent of dilution, and AU and AS are the absorbances of the solution from the Tablet and the Standard solution, respectively. Assay— Mobile phase, Standard preparation, and System suitability preparation— Proceed as directed in the Assay under Ritodrine Hydrochloride. Assay preparation— Weigh and finely powder not less than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 20 mg of ritodrine hydrochloride, to a 100-mL volumetric flask. Add about 70 mL of Mobile phase, stir for about 15 minutes, dilute with Mobile phase to volume, mix, and filter a portion to remove any particulate matter. Chromatographic system— Proceed as directed in the Assay under Ritodrine Hydrochloride Injection. Procedure— Proceed as directed in the Assay under Ritodrine Hydrochloride. Calculate the quantity, in mg, of C17H21NO3·HCl in the portion of Tablets taken by the formula: 100C(rU / rS) in which the terms are as defined therein. Auxiliary Information— Please check for your question in the FAQs before contacting USP. Topic/Question Contact Expert Committee Monograph Daniel K. Bempong, Ph.D. Senior Scientist 1-301-816-8143 (MDPS05) Monograph Development-Pulmonary and Steroids Reference Standards Lili Wang, Technical Services Scientist 1-301-816-8129 RSTech@usp.org 711 Margareth R.C. Marques, Ph.D. Senior Scientist 1-301-816-8106 (BPC05) Biopharmaceutics05 USP32–NF27 Page 3519 Chromatographic Column— RITODRINE HYDROCHLORIDE TABLETS Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27. |
2楼2012-09-21 14:27:56
