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[求助] 鹽酸利托君片質(zhì)量標(biāo)準(zhǔn)

中檢所進(jìn)口藥品復(fù)核標(biāo)準(zhǔn)(5)里的鹽酸利托君片。有的麻煩傳分，謝謝！

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豆哥: 金幣+2, 歡迎常來生產(chǎn)版交流學(xué)習(xí)~~~ 2012-09-21 14:34:19
wh168ren: 金幣+1, ★有幫助, 謝謝，不過你發(fā)得是美國藥典32上的標(biāo)準(zhǔn)。 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.

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天道酬勤

2樓2012-09-21 14:27:56

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