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申建宇

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[求助] 求助格列美脲片的质量标准

求助格列美脲片的质量标准
或者其他国家的药典相关内容（格列美脲片的质量标准）！！！

[ 来自科研家族木虫有机 ]

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一只聪明的猪。。。

1楼2011-10-16 23:03:10

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zwj959

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申建宇(金币+2): 2011-10-18 12:57:58

药品标准查询数据库（Drug Standard Database）药品名称标准来源页码标准号标准全文
格列美脲片新药转正标准第74册 147
格列美脲片新药转正标准第67册 180
格列美脲片新药转正标准第51册 167  PDF
格列美脲片(亚莫利) 进口药品复核标准汇编2000年P154,P157,P160(1-640页为上册),中检所进口药品复核标准(12)NO728  JX19990344
格列美脲片 FSDA下发的进口注册标准(4) NO211 JX20020305

©2011 DrugFuture->Drug Standard Database

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2楼2011-10-18 10:23:14

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【答案】应助回帖

申建宇(金币+3): 2011-10-18 12:57:48
申建宇(金币+2): 2011-10-18 12:58:12
申建宇(金币+3): 2011-10-24 17:10:48

USP32–NF27 Page 2498
Glimepiride Tablets
» Glimepiride Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of glimepiride (C24H34N4O5S).
Packaging and storage— Preserve in well-closed containers. Store at controlled room temperature.
USP Reference standards 11—
USP Glimepiride RS  .
USP Glimepiride Related Compound B RS  .
USP Glimepiride Related Compound C RS  .
Identification— The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Uniformity of dosage units 905: meet the requirements.
Related compounds— [note—Store the solutions containing glimepiride for no longer than 24 hours.]
Mobile phase and Diluent— Prepare as directed in the Assay.
System suitability solution— Prepare a solution in Diluent containing about 0.04 mg of USP Glimepiride RS per mL and about 0.02 mg each of USP Glimepiride Related Compound B RS and USP Glimepiride Related Compound C RS per mL. Pipet a 5.0-mL aliquot of this solution into a 50-mL volumetric flask, dilute with Diluent to volume, and mix.
Sensitivity solution— Pipet a 5.0-mL aliquot of the System suitability solution into a 100-mL volumetric flask, dilute with Diluent to volume, and mix.
Test solution— Weigh and finely powder not fewer than 10 Tablets, and transfer an accurately weighed portion of the powder to a 50-mL centrifuge tube. Add Diluent to prepare a solution containing about 0.1 mg of glimepiride per mL, based on the label claim. Sonicate in a water bath at a temperature not to exceed 20 for not less than 5 minutes and not more than 10 minutes, with occasional mixing. Centrifuge the samples, and use the clear supernatant.
Chromatographic system (see Chromatography 621)— The liquid chromatograph is equipped with a 228-nm detector and a 4-mm × 25-cm column that contains packing L1. The flow rate is about 1 mL per minute. Chromatograph the System suitability solution, and identify the glimepiride peak and the peaks due to the related compounds on the basis of the relative retention times, which are about 0.2 for glimepiride related compound B, about 0.3 for glimepiride related compound C, and 1.0 for glimepiride. Record the peak responses as directed for Procedure: the resolution, R, between glimepiride related compounds B and C is not less than 4, and the relative standard deviation of the glimepiride peak for replicate injections is not more than 2.0%. Chromatograph the Sensitivity solution, and calculate the signal-to-noise ratio, S/N, for the peaks of glimepiride related compounds B and C by the formula:
(2H)/h
in which H is the measured height of the respective related compound peak, and h is the amplitude of the average measured baseline noise. The S/N for each peak is not less than 10.
Procedure— Inject a volume (about 10 µL) of the Test solution into the chromatograph, record the chromatograms, and measure the peak responses. Continue the elution for at least two times the retention time of the glimepiride peak. Calculate the percentage of each impurity in the portion of Tablets taken by the formula:
100(1 / F)(rU / rs)
in which F is the relative response factor, which is equal to 1.3 for glimepiride related compound B and 1.0 for any other impurity; rU is the peak response for each impurity obtained from the Test solution; and rs is the sum of the responses of all the peaks in the Test solution. Disregard any peak less than 0.1%. Not more than 2.5% of glimepiride related compound B is found, not more than 0.5% of any other individual impurity is found, not more than 1.0% of total impurities excluding glimepiride related compound B is found, and not more than 3.5% of overall total impurities (including glimepiride related compound B) is found.
Assay— [note—Store the solutions containing glimepiride no longer than 24 hours.]
Mobile phase— Dissolve 0.5 g of monobasic sodium phosphate in 500 mL of water. Adjust with 10% phosphoric acid to a pH of 2.1 to 2.7, add 500 mL of acetonitrile, and mix.
Diluent— Prepare a mixture of acetonitrile and water (9:1).
System suitability preparation— Prepare a solution in Diluent containing 0.1 mg of USP Glimepiride RS per mL and 0.02 mg each of USP Glimepiride Related Compound B RS and USP Glimepiride Related Compound C RS per mL.
Standard preparation— Dissolve an accurately weighed quantity of USP Glimepiride RS in Diluent to obtain a solution having a known concentration of about 0.1 mg per mL.
Assay preparation— Transfer five whole Tablets into a suitable volumetric flask to prepare a solution of approximately 0.1 mg of glimepiride per mL, based on the label claim. Add water to 10% of the volume of the flask. Shake the flask to completely dissolve the tablets. Add acetonitrile to about 70% of the volume of the flask, and swirl. Sonicate the samples in a water bath not to exceed 20 for not less than 5 minutes and not more than 10 minutes with occasional shaking. Allow the solutions to come to room temperature, dilute with acetonitrile to volume, mix, and filter.
Chromatographic system (see Chromatography 621)— The liquid chromatograph is equipped with a 228-nm detector and a 4-mm × 12.5-cm column that contains packing L1. The flow rate is about 1 mL per minute. Chromatograph the System suitability preparation, and identify the glimepiride peak and the peaks due to the related compounds based on their relative retention times, which are about 0.25 for glimepiride related compound B, about 0.35 for glimepiride related compound C, and 1.0 for glimepiride. Record the peak responses as directed for Procedure: the resolution, R, between glimepiride related compounds B and C is not less than 1.5, and the tailing factor for the glimepiride peak is not more than 2.0. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the relative standard deviation for replicate injections is not more than 2.0%.
Procedure— Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the areas for the major peaks. Calculate the percentage of the labeled amount of glimepiride (C24H34N4O5S) in the portion of Tablets taken by the formula:
100(CS / CU)(rU / rS)
in which CS is the concentration, in mg per mL, of glimepiride in the Standard preparation; CU is the concentration of glimepiride in the Assay preparation, based on the labeled quantity per Tablet and the extent of dilution; and rU and rS are the peak responses for glimepiride obtained from the Assay preparation and the Standard preparation, respectively.

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守候在风中的宁静。

3楼2011-10-18 10:33:50

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