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tianya716

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[交流] 急求美国药典！瑞格列奈的标准

那位老师、大哥、大姐有美国药典，麻烦给一份给我，我万分感激！

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kj.x

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Repaglinide

C27H36N2O4 452.59
(S)-2-Ethyoxy-4-[2-[[methyl-1-[2-[(1-piperidinyl)phenyl]butyl]amino]-2-oxoethyl]-benzoic acid.
(+)-2-Ethoxy--[[(S)--isobutyl-o-piperidinobenzyl]carbamoyl]-p-toluic acid [135062-02-1].
» Repaglinide contains not less than 98.0 percent and not more than 101.0 percent of C27H36N2O4, calculated on the dried basis.
Packaging and storage— Preserve in tight containers.
USP Reference standards 11—
USP Repaglinide RS  .
USP Repaglinide Related Compound A RS  .
USP Repaglinide Related Compound B RS  .
USP Repaglinide Related Compound C RS  .
Identification—
A: Infrared Absorption 197K.
B: Ultraviolet Absorption 197U—
Solution: 25 µg per mL.
Medium: methanol.
Specific rotation 781S : between +6.3 and +7.3, at 20.
Test solution: 50 mg per mL, in methanol.
Loss on drying (see Thermal Analysis 891)— Determine the percentage of volatile substances by thermogravimetric analysis on an appropriately calibrated instrument, using about 30 mg of Repaglinide, accurately weighed. Heat the specimen at the rate of 10 per minute between 30 and 210 in an atmosphere of nitrogen at a flow rate of 200 mL per minute. From the thermogram, determine the accumulated loss in weight between 30 and 200: it loses not more than 0.7% of its weight.
Residue on ignition 281: not more than 0.1%, an ignition temperature of 600 ± 25 being used.
Heavy metals, Method II 231: 0.001%.
Chromatographic purity—
Solution A— Prepare a filtered and degassed monobasic potassium phosphate solution (3 in 1000). Adjust with 1 N sodium hydroxide to a pH of 7.0.
Solution B— Use filtered and degassed methanol.
Mobile phase— Use variable mixtures of Solution A and Solution B as directed for Chromatographic system. Make adjustments if necessary (see System Suitability under Chromatography 621).
System suitability solution— Dissolve accurately weighed quantities of USP Repaglinide RS,USP Repaglinide Related Compound A RS, USP Repaglinide Related Compound B RS, and USP Repaglinide Related Compound C RS in methanol to obtain a solution having known concentrations of about 10 mg of USP Repaglinide RS per mL and 100 µg each of the related compound Reference Standards per mL.
Test solution— Transfer about 100 mg of Repaglinide, accurately weighed, to a 10-mL volumetric flask, dissolve in and dilute with methanol to volume, and mix.
Standard solution— Transfer 0.1 mL of the Test solution to a 10-mL volumetric flask, dilute with methanol to volume, and mix.
Chromatographic system (see Chromatography 621)— Prepare as directed in the Assay, except to program the chromatograph as follows.
Time
(minutes) Solution A
(%) Solution B
(%) Elution
0 50 50 equilibration
0–2 50®30 50®70 linear gradient
2–8 30 70 isocratic
8–12 30®5 70®95 linear gradient
12–15 5 95 isocratic

Chromatograph the System suitability solution, and record the peak areas as directed for Procedure: the relative retention times are about 0.3 for repaglinide related compound B, 0.9 for repaglinide related compound C, 1.0 for repaglinide, and 1.6 for repaglinide related compound A. Chromatograph the Standard solution, and record the peak areas as directed for Procedure: the relative standard deviation for replicate injections is not more than 10%.
Procedure— Separately inject equal volumes (about 3 µL) of the Test solution and the Standard solution into the chromatograph, record the chromatograms, and measure the peak areas. Calculate the percentage of each impurity, other than repaglinide related compound A, in the portion of Repaglinide taken by the formula:
ri / rS
in which ri is the peak response for each impurity obtained from the Test solution; and rS is the peak response of repaglinide obtained from the Standard solution. For repaglinide related compound A, use the same formula, but multiply the result by a response factor equal to 2.0: not more than 0.1% of any individual impurity is found, and not more than 0.5% of total impurities is found.
Assay—
Buffer solution— Prepare a monobasic potassium phosphate solution (1 in 1000), and adjust with phosphoric acid to a pH of 2.5.
Mobile phase— Prepare a filtered and degassed mixture of methanol and Buffer solution (80:20).
System suitability preparation— Dissolve accurately weighed quantities of USP Repaglinide RS and USP Repaglinide Related Compound B RS in methanol to obtain a solution having known concentrations of about 500 µg per mL and 40 µg per mL, respectively.
Standard preparation— Dissolve an accurately weighed quantity of USP Repaglinide RS in methanol, and dilute quantitatively, and stepwise if necessary, with methanol to obtain a solution having a known concentration of about 500 µg per mL.
Assay preparation— Transfer about 25 mg of Repaglinide, accurately weighed, to a 50-mL volumetric flask, dissolve in and dilute with methanol to volume, and mix.
Chromatographic system (see Chromatography 621)— The liquid chromatograph is equipped with a 240-nm detector and a 4.6-mm × 12.5-cm column that contains 5-µm packing L1. The flow rate is about 1.0 mL per minute. The column temperature is maintained at 45. Chromatograph the System suitability preparation, and record the peak areas as directed for Procedure: the relative retention times are about 1.0 for repaglinide and 0.4 for repaglinide related compound B. Chromatograph the Standard preparation, and record the peak areas 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 quantity, in mg, of C27H36N2O4 in the portion of Repaglinide taken by the formula:
50C(rU / rS)
in which C is the concentration, in mg per mL, of USP Repaglinide RS in the Standard preparation; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Staff Liaison : Elena Gonikberg, Ph.D., Senior Scientist
Expert Committee : (MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine
USP31–NF26 Page 3166
Pharmacopeial Forum : Volume No. 27(6) Page 3325
Phone Number : 1-301-816-8251
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9楼2008-11-16 20:58:37
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wu9820168

铁杆木虫 (正式写手)
★ ★ ★ ★ ★
tianya716(金币+5,VIP+0):谢谢帮忙！
Repaglinide

C27H36N2O4 452.59
(S)-2-Ethyoxy-4-[2-[[methyl-1-[2-[(1-piperidinyl)phenyl]butyl]amino]-2-oxoethyl]-benzoic acid.
(+)-2-Ethoxy--[[(S)--isobutyl-o-piperidinobenzyl]carbamoyl]-p-toluic acid [135062-02-1].
» Repaglinide contains not less than 98.0 percent and not more than 101.0 percent of C27H36N2O4, calculated on the dried basis.
Packaging and storage— Preserve in tight containers.
USP Reference standards 11—
USP Repaglinide RS  .
USP Repaglinide Related Compound A RS  .
USP Repaglinide Related Compound B RS  .
USP Repaglinide Related Compound C RS  .
Identification—
A: Infrared Absorption 197K.
B: Ultraviolet Absorption 197U—
Solution: 25 µg per mL.
Medium: methanol.
Specific rotation 781S : between +6.3 and +7.3, at 20.
Test solution: 50 mg per mL, in methanol.
Loss on drying (see Thermal Analysis 891)— Determine the percentage of volatile substances by thermogravimetric analysis on an appropriately calibrated instrument, using about 30 mg of Repaglinide, accurately weighed. Heat the specimen at the rate of 10 per minute between 30 and 210 in an atmosphere of nitrogen at a flow rate of 200 mL per minute. From the thermogram, determine the accumulated loss in weight between 30 and 200: it loses not more than 0.7% of its weight.
Residue on ignition 281: not more than 0.1%, an ignition temperature of 600 ± 25 being used.
Heavy metals, Method II 231: 0.001%.
Chromatographic purity—
Solution A— Prepare a filtered and degassed monobasic potassium phosphate solution (3 in 1000). Adjust with 1 N sodium hydroxide to a pH of 7.0.
Solution B— Use filtered and degassed methanol.
Mobile phase— Use variable mixtures of Solution A and Solution B as directed for Chromatographic system. Make adjustments if necessary (see System Suitability under Chromatography 621).
System suitability solution— Dissolve accurately weighed quantities of USP Repaglinide RS,USP Repaglinide Related Compound A RS, USP Repaglinide Related Compound B RS, and USP Repaglinide Related Compound C RS in methanol to obtain a solution having known concentrations of about 10 mg of USP Repaglinide RS per mL and 100 µg each of the related compound Reference Standards per mL.
Test solution— Transfer about 100 mg of Repaglinide, accurately weighed, to a 10-mL volumetric flask, dissolve in and dilute with methanol to volume, and mix.
Standard solution— Transfer 0.1 mL of the Test solution to a 10-mL volumetric flask, dilute with methanol to volume, and mix.
Chromatographic system (see Chromatography 621)— Prepare as directed in the Assay, except to program the chromatograph as follows.
Time
(minutes) Solution A
(%) Solution B
(%) Elution
0 50 50 equilibration
0–2 50®30 50®70 linear gradient
2–8 30 70 isocratic
8–12 30®5 70®95 linear gradient
12–15 5 95 isocratic

Chromatograph the System suitability solution, and record the peak areas as directed for Procedure: the relative retention times are about 0.3 for repaglinide related compound B, 0.9 for repaglinide related compound C, 1.0 for repaglinide, and 1.6 for repaglinide related compound A. Chromatograph the Standard solution, and record the peak areas as directed for Procedure: the relative standard deviation for replicate injections is not more than 10%.
Procedure— Separately inject equal volumes (about 3 µL) of the Test solution and the Standard solution into the chromatograph, record the chromatograms, and measure the peak areas. Calculate the percentage of each impurity, other than repaglinide related compound A, in the portion of Repaglinide taken by the formula:
ri / rS
in which ri is the peak response for each impurity obtained from the Test solution; and rS is the peak response of repaglinide obtained from the Standard solution. For repaglinide related compound A, use the same formula, but multiply the result by a response factor equal to 2.0: not more than 0.1% of any individual impurity is found, and not more than 0.5% of total impurities is found.
Assay— Buffer solution— Prepare a monobasic potassium phosphate solution (1 in 1000), and adjust with phosphoric acid to a pH of 2.5.
Mobile phase— Prepare a filtered and degassed mixture of methanol and Buffer solution (80:20).
System suitability preparation— Dissolve accurately weighed quantities of USP Repaglinide RS and USP Repaglinide Related Compound B RS in methanol to obtain a solution having known concentrations of about 500 µg per mL and 40 µg per mL, respectively.
Standard preparation— Dissolve an accurately weighed quantity of USP Repaglinide RS in methanol, and dilute quantitatively, and stepwise if necessary, with methanol to obtain a solution having a known concentration of about 500 µg per mL.
Assay preparation— Transfer about 25 mg of Repaglinide, accurately weighed, to a 50-mL volumetric flask, dissolve in and dilute with methanol to volume, and mix.
Chromatographic system (see Chromatography 621)— The liquid chromatograph is equipped with a 240-nm detector and a 4.6-mm × 12.5-cm column that contains 5-µm packing L1. The flow rate is about 1.0 mL per minute. The column temperature is maintained at 45. Chromatograph the System suitability preparation, and record the peak areas as directed for Procedure: the relative retention times are about 1.0 for repaglinide and 0.4 for repaglinide related compound B. Chromatograph the Standard preparation, and record the peak areas 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 quantity, in mg, of C27H36N2O4 in the portion of Repaglinide taken by the formula:
50C(rU / rS)
in which C is the concentration, in mg per mL, of USP Repaglinide RS in the Standard preparation; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Staff Liaison : Elena Gonikberg, Ph.D., Senior Scientist
Expert Committee : (MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine
USP31–NF26 Page 3166
Pharmacopeial Forum : Volume No. 27(6) Page 3325
Phone Number : 1-301-816-8251

http://www.uspbpep.com/usp31/v31260/usp31nf26s1_m73165.asp
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2楼2008-11-10 19:13:47
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wu9820168

铁杆木虫 (正式写手)
★ ★ ★ ★ ★
tianya716(金币+5,VIP+0):感谢帮忙！
Repaglinide Tablets
» Repaglinide Tablets contain not less than 95.0 percent and not more than 105.0 percent of the labeled amount of repaglinide (C27 H36N2O4).
Packaging and storage— Preserve in tight containers.
USP Reference standards 11—
USP Repaglinide RS  .
USP Repaglinide Related Compound A RS  .
Identification—
A: Thin-Layer Chromatographic Identification Test 201—
Test solution— Transfer an accurately weighed quantity of powdered Tablets, equivalent to about 10 mg of repaglinide, to a suitable container, add 10 mL of a mixture of methanol and methylene chloride (1:1), shake for 15 minutes, and centrifuge.
Developing solvent system: a mixture of toluene, methylene chloride, and methanol (2:2:1).
B: The retention time and UV spectrum of the major peak in the chromatogram of the Assay preparation correspond to those in the chromatogram of the Standard preparation, as obtained in the Assay.
Dissolution 711—
Medium: pH 5.0 buffer, prepared by mixing 10.2 g of citric acid monohydrate and 18.16 g of dibasic sodium phosphate dihydrate with 1 L of water; 900 mL.
Apparatus 2: 75 rpm.
Time: 30 minutes.
Determine the amount of C27H36N2O4 dissolved by employing the following method.
Buffer solution— Prepare a monobasic potassium phosphate solution (1.5 in 1000), and adjust with phosphoric acid to a pH of 2.3.
Mobile phase— Prepare a filtered and degassed mixture of acetonitrile, Buffer solution, and methanol (49:40:11).
Standard solution— Transfer about 22 mg of USP Repaglinide RS, accurately weighed, to a 100-mL volumetric flask, dissolve in and dilute with methanol to volume, and mix. Transfer 5.0 mL of this solution to a 100-mL volumetric flask, and dilute with methanol to volume. Transfer 5.0 mL of the resulting solution to a 100-mL volumetric flask, add 25 mL of methanol, dilute with Medium to volume, and mix.
Chromatographic system (see Chromatography 621)— The liquid chromatograph is equipped with a fluorometric detector, set at an excitation wavelength of 244 nm and an emission wavelength of 348 nm, and a 4.0-mm × 12.5-cm column that contains 10-µm packing L1. The column temperature is maintained at 40. The flow rate is about 1.0 mL per minute. Chromatograph the Standard solution, and record the peak responses as directed for Procedure: the capacity factor, k¢, is about 1.8; the tailing factor is between 0.5 and 2.0; and the relative standard deviation for replicate injections is not more than 2.0%.
Procedure— Separately inject equal volumes (about 20 µL) of the Standard solution and a filtered portion of the solution under test into the chromatograph, record the chromatograms, and measure the areas for the major peaks. Calculate the quantity of C27H36N2O4 dissolved by comparing the measured peak responses of the Standard solution and the solution under test.
Tolerances— Not less than 70% (Q) of the labeled amount of C27H36N2O4 is dissolved in 30 minutes.
Uniformity of dosage units 905: meet the requirements.
Loss on drying 731— Dry about 2 g of finely ground Tablets, accurately weighed, at 105 for 3 hours: it loses not more than 6.0% of its weight.
Chromatographic purity—
pH 4.0 Phosphate buffer, pH 2.5 Phosphate buffer, Diluent, and Mobile phase— Proceed as directed in the Assay.
Standard solution 1, Standard solution 2, and System suitability solution— Proceed as directed in the Assay for Standard preparation 1, Standard preparation 2, and System suitability preparation, respectively.
Standard solution 3— Transfer 2.5 mL of Standard solution 2 to a 1-liter volumetric flask, dilute with Diluent to volume, and mix.
Test solution— Use the Assay preparation.
Chromatographic system (see Chromatography 621)— The liquid chromatograph is equipped with a 210-nm diode array detector and a 4.0-mm × 6-cm column that contains 5-µm packing L1. The column temperature is maintained at 40. The flow rate is about 1.0 mL per minute. Chromatograph the System suitability solution, and record the peak responses as directed for Procedure: the capacity factors, k¢, for repaglinide and repaglinide related compound A are about 4.9 and 1.2, respectively; the resolution, R, between the two peaks is not less than 7.0; and the tailing factor is between 0.8 and 2.0. Chromatograph Standard solution 3, and record the peak responses as directed for Procedure: the relative standard deviation for replicate injections is not more than 10%.
Procedure— Separately inject equal volumes (about 20 µL) of Standard solution 2 and the Test solution into the chromatograph, record the chromatograms, and measure all of the peak responses. Calculate the percentage of each impurity in the portion of Tablets taken by the formula:
100(ri / rS)
in which ri is the peak response for each impurity in the Test solution; and rS is the repaglinide peak response obtained from Standard solution 2: not more than 0.5% of total impurities is found.
Assay— pH 4.0 Phosphate buffer— Prepare a monobasic ammonium phosphate solution (2 in 1000), and adjust with phosphoric acid to a pH of 4.0.
pH 2.5 Phosphate buffer— Prepare a monobasic ammonium phosphate solution (2 in 1000), and adjust with phosphoric acid to a pH of 2.5.
Diluent— Prepare a mixture of methanol and pH 4.0 Phosphate buffer (7:3).
Mobile phase— Prepare a filtered and degassed mixture of methanol and pH 2.5 Phosphate buffer (7:3).
Standard preparation 1— Dissolve an accurately weighed quantity of USP Repaglinide RS in methanol to obtain a solution having a known concentration of about 800 µg per mL.
Standard preparation 2— Transfer 5.0 mL of Standard preparation 1 to a 50-mL volumetric flask, dilute with Diluent to volume, and mix.
System suitability preparation— Dissolve an accurately weighed quantity of USP Repaglinide Related Compound A RS in methanol to obtain a solution having a known concentration of about 80 µg per mL. Transfer 1.0 mL of this solution to a 50-mL volumetric flask, add 5.0 mL of Standard preparation 1, dilute with Diluent to volume, and mix.
Assay preparation— Transfer 8 whole Tablets to a suitable volumetric flask, and dissolve in and dilute with Diluent to volume to obtain a solution having a concentration of about 80 µg per mL. Stir for 20 minutes with the aid of a magnetic stirrer, and filter a portion of the solution.
Chromatographic system (see Chromatography 621)— The liquid chromatograph is equipped with a 245-nm diode array detector and a 4.0-mm × 6-cm column that contains 5-µm packing L1. The column temperature is maintained at 40. The flow rate is about 1.0 mL per minute. Chromatograph the System suitability preparation, and record the peak responses as directed for Procedure: the capacity factors, k¢, for repaglinide and repaglinide related compound A are about 4.9 and 1.2, respectively; the resolution, R, between the two peaks is not less than 7.0; and the tailing factor is between 0.8 and 2.0. Chromatograph Standard preparation 2, 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 20 µL) of Standard preparation 2 and the Assay preparation into the chromatograph, record the chromatograms, and measure the areas for the major peaks. Calculate the quantity, in mg, of repaglinide (C27H36N2O4) in each of the Tablets taken by the formula:
(VC/ 8)(rU / rS)
in which V is the volume, in mL, of Diluent used in the Assay preparation; C is the concentration, in mg per mL, of USP Repaglinide RS in Standard preparation 2; and rU and rS are the peak responses obtained from the Assay preparation and Standard preparation 2, respectively.
Auxiliary Information— Staff Liaison : Elena Gonikberg, Ph.D., Senior Scientist
Expert Committee : (MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine
USP31–NF26 Page 3166
Phone Number : 1-301-816-8251

http://www.uspbpep.com/usp31/v31260/usp31nf26s1_m73167.asp
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3楼2008-11-10 19:14:17
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tianya716

木虫 (正式写手)
谢谢！片“Repaglinide Tablets”的标准有吗？
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4楼2008-11-10 19:16:54
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