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【求助】他唑巴坦钠质量标准
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| 据说美国药典usp-25中有他唑巴坦钠质量标准，哪位老师能提供，不胜感激！ |
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lemonin2008
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xiaominglin(金币+2):谢谢您，他唑巴坦的质量标准我也查到了，不过我需要的是他唑巴坦钠的质量标准！不知您能否帮忙查到！ 2010-10-31 10:48:15
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USP32-NF27 他唑巴坦 Tazobactam C10H12N4O5S 300.29 4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, 3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-, 4,4-dioxide, [2S-(2,3,5)]-. (2S,3S,5R)-3-Methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, 4,4-dioxide [89786-04-9]. » Tazobactam contains not less than 98.0 percent and not more than 102.0 percent of C10H12N4O5S, calculated on the anhydrous basis. Packaging and storage— Preserve in well-closed containers. Store at controlled room temperature. USP Reference standards 11— USP Endotoxin RS. USP Tazobactam RS. USP Tazobactam Related Compound A RS. Identification— A: Infrared Absorption 197K , on an undried specimen. B: 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. Bacterial endotoxins 85— The level of Bacterial Endotoxins are such that the requirements under the relevant dosage form monograph(s) in which Tazobactam is used can be met. Specific rotation 781S: between 160 and 167 (t = 20). Test solution: 10 mg per mL, in dimethylformamide. Microbial enumeration tests 61 and Tests for specified microorganisms 62— The total aerobic microbial count does not exceed 1000 cfu per g, and the total combined molds and yeasts count does not exceed 100 cfu per g. pH 791: between 1.8 and 2.8, in a solution containing 2.5 mg per mL. Water, Method I 921: not more than 0.6%. Residue on ignition 281: not more than 0.1%. Heavy metals, Method II 231: 0.002%. Related compounds— Mobile phase, l-Phenylalanine solution, System suitability solution, and Chromatographic system— Prepare as directed in the Assay. Blank— Use water. Standard solution— Use the Standard preparation, prepared as directed in the Assay. Test solution— Use the Assay preparation. Procedure— Cool and maintain the Standard solution, the System suitability solution, the Blank, and the Test solution at 3 until injection. [note—If an autosampler is used, replace the plastic tubing connected to the injection needle with a stainless steel assembly, and maintain at 3. If a chilled autosampler is not used, then these solutions should be injected immediately after preparation.] Separately inject equal volumes (about 20 µL) of the Standard solution, the System suitability solution, the Blank, and the Test solution into the chromatograph; record the chromatograms; and measure the area responses for the peaks. Calculate the percentage of each related compound in the portion of Tazobactam taken by the formula: 100(ri / rs) in which ri is the response for each related compound in the chromatogram obtained from the Test solution, and rs is the sum of the peak responses of all the peaks in the chromatogram obtained from the Test solution: not more than 1.0% of tazobactam related compound A is found; not more than 0.1% of any other individual impurity is found; and the sum of all impurities found, other than tazobactam related compound A, is not greater than 0.3%. [note—Ignore any peaks in the chromatogram of the Test solution that correspond to any peaks in the chromatogram of the Blank.] Assay— Mobile phase— Dissolve 1.32 g of dibasic ammonium phosphate in 750 mL of water. Adjust with 5% (v/v) phosphoric acid to a pH of 2.5, dilute with water to 1000 mL, and mix. Add 30 mL of acetonitrile, mix, and pass through a filter having a 0.2-µm porosity. Make adjustments if necessary (see System Suitability under Chromatography 621). Standard preparation— Dissolve accurately weighed quantities of USP Tazobactam RS and USP Tazobactam Related Compound A RS in water to obtain a solution having known concentrations of about 0.5 mg per mL and 0.08 mg per mL, respectively. l-Phenylalanine solution— Prepare an aqueous solution of l-phenylalanine containing 0.8 mg per mL. System suitability solution— Pipet 1.0 mL of l-Phenylalanine solution and 5.0 mL of the Standard preparation into a 50-mL volumetric flask. Dilute with water to volume, and mix. [note—Maintain this solution at 3 until injection. Prepare fresh daily.] Assay preparation— Transfer about 25 mg of Tazobactam, accurately weighed, to a 50-mL volumetric flask, dissolve in and dilute with water to volume, and mix. Chromatographic system (see Chromatography 621)— The liquid chromatograph is equipped with a 210-nm detector and a 4.6-mm × 25-cm column that contains 5-µm packing L1. The flow rate is about 1.5 mL per minute. Chromatograph 20 µL of the System suitability solution, and record the peak responses as directed for Procedure: the resolution, R, between tazobactam and l-phenylalanine is not less than 6.0; the tailing factor is not more than 1.8; and the relative standard deviation for replicate injections is not more than 2.0%. Procedure— Cool and maintain the Standard preparation, the System suitability solution, and the Assay preparation at 3 until injection. [note—If an autosampler is used, replace the plastic tubing connected to the injection needle with a stainless steel assembly, and maintain at 3. If a chilled autosampler is not used, then these solutions should be injected immediately after preparation.] 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 mg, of C10H12N4O5S in the portion of Tazobactam taken by the formula: 50C(rU / rS) in which C is the concentration, in mg per mL, of USP Tazobactam 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— Please check for your question in the FAQs before contacting USP. Topic/Question Contact Expert Committee Monograph Ahalya Wise, M.S. Scientist 1-301-816-8161 (MDANT05) Monograph Development-Antibiotics Reference Standards Lili Wang, Technical Services Scientist 1-301-816-8129 RSTech@usp.org 85 Radhakrishna S Tirumalai, Ph.D. Senior Scientist 1-301-816-8339 (MSA05) Microbiology and Sterility Assurance 61 Radhakrishna S Tirumalai, Ph.D. Senior Scientist 1-301-816-8339 (MSA05) Microbiology and Sterility Assurance 62 Radhakrishna S Tirumalai, Ph.D. Senior Scientist 1-301-816-8339 (MSA05) Microbiology and Sterility Assurance USP32–NF27 Page 3655 Pharmacopeial Forum: Volume No. 34(2) Page 302 Chromatographic Column— TAZOBACTAM Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27. |
2楼2010-10-29 17:40:27