阿奇霉素片说明书

C S= concentration of USP Azithromycin RS in the Sample solution: Nominally 1mg/mL of azithromycinStandard solution (mg/mL)in Mobile phase from NLT 20 Tablets, finely powdered.C U= nominal concentration of azithromycin in Sonicate and shake as needed to dissolve.Sample solution 1 (mg/mL)Chromatographic systemP= potency of azithromycin in USP Azithromycin(See Chromatography 〈621〉, System Suitability.) RS (µg/mg)Mode: LCF= conversion factor, 0.001mg/µg Detector: UV 210 nmWhere packaged in a multiple-unit container Column: 4.6-mm × 25-cm; 5-µm packing L1Calculate the percentage of the labeled amount of Column temperature: 50°azithromycin (C38H72N2O12) in the portion of Flow rate: 2mL/minAzithromycin for Oral Suspension taken:Injection volume: 100µLSystem suitabilityResult = (r U/r S) × (C S/C U) ×P×F× 100Sample:Standard solutionSuitability requirementsr U= peak response from Sample solution 2Tailing factor: NMT 2.0, Standard solutionr S= peak response from the Standard solution Relative standard deviation: NMT 2.0%, StandardC S= concentration of USP Azithromycin RS in the solutionStandard solution (mg/mL)AnalysisC U= nominal concentration of azithromycin in Samples:Standard solution and Sample solutionSample solution 2 (mg/mL)Calculate the percentage of the labeled amount of P= potency of azithromycin in USP Azithromycin azithromycin (C38H72N2O12) in the portion of Tablets RS (µg/mg)taken:F= conversion factor, 0.001mg/µgAcceptance criteria: 90.0%–110.0%Result = (r U/r S) × (C S/C U) ×P×F× 100PERFORMANCE TESTS rU= peak response of azithromycin from the•D ELIVERABLE V OLUME〈698〉: Meets the requirements Sample solution•U NIFORMITY OF D OSAGE U NITS〈905〉rS= peak response of azithromycin from the For single-unit containers Standard solutionAcceptance criteria: Meets the requirements CS= concentration of USP Azithromycin RS in theStandard solution (mg/mL)SPECIFIC TESTS CU= nominal concentration of azithromycin in the •P H 〈791〉Sample solution (mg/mL) For a solid packaged in single-unit containers:P= potency of USP Azithromycin RS (µg/mg)9.0–11.0, in the suspension constituted as directed in F= conversion factor, 0.001mg/µgthe labeling Acceptance criteria: 90.0%–110.0%For a solid packaged in multiple-unit containers:8.5–11.0, in the suspension constituted as directed in PERFORMANCE TESTSthe labeling•D ISSOLUTION〈711〉Medium: pH 6.0phosphate buffer; 900mL ADDITIONAL REQUIREMENTS Apparatus 2: 75 rpm•P ACKAGING AND S TORAGE: Preserve in tight containers.Time: 30 min•USP R EFERENCE S TANDARDS〈11〉Solution A: 4.4mg/mL of dibasic potassium phosphate USP Azaerythromycin A RS and 0.5mg/mL of sodium 1-octanesulfonate, adjusted 9-Deoxo-9a-aza-9a-homoerythromycin A;with phosphoric acid to a pH of 8.20 ± 0.056-Demethylazithromycin.Mobile phase: Acetonitrile, methanol, and Solution A C37H70N2O12734.96(9:3:8)USP Azithromycin RS Diluent: 17.5mg/mL of dibasic potassium phosphate.Adjust with phosphoric acid to a pH of 8.00 ± 0.05.Prepare a mixture of this solution and acetonitrile(80:20).Standard stock solution: Dissolve USP Azithromycin RS Azithromycin Tablets in Medium to obtain a solution having a known concen-tration of about (L/1000) mg/mL, where L is the Tablet DEFINITION label claim in mg.Azithromycin Tablets contain NLT 90.0% and NMT 110.0%Standard solution: Dilute the Standard stock solutionof the labeled amount of azithromycin (C38H72N2O12).with Diluent to obtain a solution having a known con-centration of about (L/2000) mg/mL, where L is the IDENTIFICATION Tablet label claim in mg.•A. The retention time of the major peak of the Sample Sample solution: Pass a portion of the solution under solution corresponds to that of the Standard solution, as test through a suitable filter of 0.45-µm pore size. Di-obtained in the Assay.lute a portion of the filtrate with Diluent to obtain asolution having a theoretical concentration of about ASSAY(L/2000) mg/mL, where L is the Tablet label claim in•P ROCEDURE mg, assuming complete dissolution.Buffer: Dissolve 4.6g of monobasic potassium phos-Chromatographic systemphate anhydrous in 900mL of water. Adjust with 1N(See Chromatography 〈621〉, System Suitability.)sodium hydroxide to a pH of 7.5, and dilute with waterto 1L.Mobile phase: Acetonitrile and Buffer (65:35)Standard solution: 1mg/mL of USP Azithromycin RS inMobile phase. Sonicate and shake as needed to dissolve.Mode: LC Standard stock solution: 0.4mg/mL of USP Azithro-Detector: UV 210 nm mycin RS in acetonitrile. Sonicate and shake as needed Column: 4.6-mm × 15-cm; 5-µm packing L1to dissolve.Column temperature: 50°Standard solution: 0.02mg/mL of azithromycin from Flow rate: 1.5mL/min Standard stock solution in Diluent AInjection volume: 50µL Sensitivity solution: 0.004mg/mL of azithromycin System suitability from Standard solution in Diluent ASample:Standard solution Sample stock solution: Nominally 14.3mg/mL of Suitability requirements azithromycin prepared as follows. Weigh and finely Tailing factor: NMT 2.0powder NLT 20 Tablets. Transfer nominally 1430mg of Relative standard deviation: NMT 2.0%azithromycin to a 100-mL volumetric flask. Add 75mL Analysis of acetonitrile, and sonicate for NLT 15 min. Shake by Samples:Standard solution and Sample solution mechanical means for NLT 15 min. Allow the solution Calculate the percentage of the labeled amount of to equilibrate to room temperature, dilute with acetoni-azithromycin (C38H72N2O12) dissolved:trile to volume, and mix.Sample solution: Nominally 4mg/mL of azithromycin Result = (r U/r S) × (C S/L) ×V× 100prepared as follows. Centrifuge an aliquot of the Samplestock solution for NLT 15 min. Transfer 7.0mL of the r U= peak response of azithromycin from the supernatant to a 25-mL volumetric flask, and dilute Sample solution with Diluent B to volume.r S= peak response of azithromycin from the Blank:Diluent AStandard solution Chromatographic systemC S= concentration of the Standard solution(See Chromatography 〈621〉, System Suitability.)(mg/mL)Mode: LCL= label claim (mg/Tablet)Detector: UV 210 nmV= volume of Medium, 900mL Column: 4.6-mm × 15-cm; 3.5-µm packing L1 Tolerances: NLT 80% (Q) of the labeled amount of Column temperature: 50°azithromycin (C38H72N2O12) is dissolved.Flow rate: 1.2mL/min•U NIFORMITY OF D OSAGE U NITS〈905〉: Meet the Autosampler temperature: 4°requirements Injection volume: 100µLSystem suitabilityIMPURITIES Samples:System suitability solution, Standard solution,•O RGANIC I MPURITIES and Sensitivity solutionProtect all solutions containing azithromycin from light.Suitability requirementsRefrigerate the Standard solution and the Sample solution Signal-to-noise ratio: NLT 10, Sensitivity solution after preparation and during analysis, using a refriger-Resolution: NLT 1.0 between desosaminylazithromy-ated autosampler set at 4°. The solutions must be ana-cin and azithromycin related compound F, System lyzed within 24 h of preparation.suitability solutionSolution A: Water and ammonium hydroxide Relative standard deviation: NMT 2.0%, Standard (2000:1.2). The pH of this solution is about 10.5.solutionSolution B: Acetonitrile, methanol, and ammonium hy-Analysisdroxide (1800:200:1.2)Samples:Sample solution and BlankMobile phase: See Table 1.Calculate the percentage of each impurity in the por-tion of Tablets taken:Table 1Result = (r U/r S) × (C S/C U) ×P×F1× (1/F2) × 100 Time Solution A Solution B(min)(%)(%)rU= peak response of each impurity from the 05446Sample solution205446r S= peak response of azithromycin from theStandard solution351090C S= concentration of USP Azithromycin RS in the35.15446Standard solution (mg/mL) 405446CU= nominal concentration of azithromycin in theSample solution (mg/mL) Buffer: 1.7g/L of monobasic ammonium phosphate inP= potency of USP Azithromycin RS (µg/mg) water. Adjust with ammonium hydroxide to a pH of 10.F1= conversion factor, 0.001mg/µg Diluent A: Methanol, acetonitrile, and BufferF2= relative response factor (see Table 2) (350:300:350)Acceptance criteria: See Table 2. The reporting level Diluent B: Methanol and Buffer (1:1)for impurities is 0.1%. Disregard any peaks in the Sam-System suitability stock solution: 0.1mg/mL each ofple solution that correspond to peaks in the Blank.USP Desosaminylazithromycin RS and USP AzithromycinRelated Compound F RS in acetonitrileSystem suitability solution: 0.028mg/mL each of USPDesosaminylazithromycin RS and USP Azithromycin Re-lated Compound F RS from System suitability stock solu-tion in Diluent ATable 2Table 2 (Continued)Relative Relative Acceptance Relative Relative AcceptanceRetention Response Criteria,Retention Response Criteria, Name Time Factor NMT (%)Name Time Factor NMT (%) Azithromycin N-ox-3-Deoxyazithro-ide a0.200.42 1.0mycin (azithro-——mycin B)h,l 1.143′-(N,N-Didemeth-yl)-3′-N-for-Any individual un-—mylazithromycin b0.29 1.7 1.0specified impurity h 1.00.23′-(N,N-Didemeth-Total impurities h—— 5.0yl)azithro-a(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10, mycin(ami-12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylazinoyl)-β-D-xylo-hex-noazithromycin)c0.340.490.5opyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.Azithromycin related b(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-compound F d0.42 4.3 1.0methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3-formamido-3,4,6-trideoxy-β-D-xylo-hexopyra-Desosaminylazithro-nosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.mycin e0.46 1.10.5c(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-N-Demethylazithro-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3-amino-3,4,6-trideoxy-β-D-xylo-hexopyra-mycin f0.500.540.7nosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.3′-De(dimethylami-d3′-(N-Demethyl)-3′-N-formylazithromycin; (2R,3S,4R,5R,8R,10R,11R,12S, no)-3′-oxoazithro-13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyra-mycin g0.87 1.4 1.0nosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3-(N-methyl)formamido-3,4,6-trideoxy-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-Azaerythromycin A h,i0.94——azacyclopentadecan-15-one.Azithromycin 1.0——e(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-2-Ethyl-3,4,10,13-tetrahydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-dimethylamino-β-D-xylo-2-Desethyl-2-prop-——hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. ylazithromycin h,j 1.10f(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-3′-N-Demethyl-3′-N-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,[(4-methylphen-12,14-heptamethyl-11-[[3,4,6-trideoxy-3-methylamino-β-D-xylo-hexopyra-——nosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.yl)sulfonyl]azithro-g(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3,3-dimethyl-α-mycin h,k 1.11L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-a(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-heptamethyl-11-[[3,4,6-trideoxy-3-oxo-β-D-xylo-hexopyranosyl]oxy]-1-oxa-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,6-azacyclopentadecan-15-one.12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylazinoyl)-β-D-xylo-hex-h Process impurities that are controlled in the drug substance are not to be opyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.reported. They are listed here for information only. The unspecified impu-b(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-rities and total impurities limits do not include these impurities.methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,i9-Deoxo-9a-aza-9a-homoerythromycin A.12,14-heptamethyl-11-[[3-formamido-3,4,6-trideoxy-β-D-xylo-hexopyra-j(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-nosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.methyl-α-L-ribo-hexopyranosyl)oxy]-2-propyl-3,4,10-trihydroxy-3,5,6,8,10, c(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hex-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,opyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one dihydrate.12,14-heptamethyl-11-[[3-amino-3,4,6-trideoxy-β-D-xylo-hexopyra-k(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-nosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10, d3′-(N-Demethyl)-3′-N-formylazithromycin; (2R,3S,4R,5R,8R,10R,11R,12S,12,14-heptamethyl-11-[[3-[N-(4-methylphenylsulfonyl)-N-methylamino]-3, 13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyra-4,6-trideoxy-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-nosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3-one.(N-methyl)formamido-3,4,6-trideoxy-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-l(2R,3R,4S,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-azacyclopentadecan-15-one.methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-4,10-dihydroxy-3,5,6,8,10,12, e(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-2-Ethyl-3,4,10,13-tetrahydroxy-3,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyra-5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-dimethylamino-β-D-xylo-nosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.f(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-ADDITIONAL REQUIREMENTSmethyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,•PACKAGING AND S TORAGE: Preserve in tight containers. 12,14-heptamethyl-11-[[3,4,6-trideoxy-3-methylamino-β-D-xylo-hexopyra-nosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.Store at controlled room temperature.g(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3,3-dimethyl-α-•USP R EFERENCE S TANDARDS〈11〉L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-USP Azithromycin RSheptamethyl-11-[[3,4,6-trideoxy-3-oxo-β-D-xylo-hexopyranosyl]oxy]-1-oxa-USP Azithromycin Related Compound F RS6-azacyclopentadecan-15-one.3′-(N-Demethyl)-3′-N-formylazithromycin;h Process impurities that are controlled in the drug substance are not to be(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dide-reported. They are listed here for information only. The unspecified impu-rities and total impurities limits do not include these impurities.oxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyra-i9-Deoxo-9a-aza-9a-homoerythromycin A.nosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,j(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-14-heptamethyl-11-[[3-(N-methyl)formamido-3,4, methyl-α-L-ribo-hexopyranosyl)oxy]-2-propyl-3,4,10-trihydroxy-3,5,6,8,10,6-trideoxy-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-aza-12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hex-cyclopentadecan-15-one.opyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one dihydrate.C38H70N2O13762.97k(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10, USP Desosaminylazithromycin RS12,14-heptamethyl-11-[[3-[N-(4-methylphenylsulfonyl)-N-methylamino]-3,(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-2-Ethyl-3,4,4,6-trideoxy-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-10,13-tetrahydroxy-3,5,6,8,10,12,14-heptamethyl-11 one.-[[3,4,6-trideoxy-3-dimethylamino-β-D-xylo-hexopyra-l(2R,3R,4S,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-nosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-4,10-dihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyra-C30H58N2O9590.79nosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.Suitability requirementsResolution: NLT 2.0 between aztreonam and aztre-Aztreonamonam E -isomer, System suitability solutionTailing factor: NMT 2 for aztreonam, System suitabil-ity solutionRelative standard deviation: NMT 2.0%, Standard solution AnalysisSamples: Standard solution and Sample solutionCalculate the percentage of aztreonam (C 13H 17N 5O 8S 2)in the portion of Aztreonam taken:Result = (r U /r S ) × (C S /C U ) × P × F × 100C 13H 17N 5O 8S 2435.43r U = peak response from the Sample solution Propanoic acid, 2-[[[1-(2-amino-4-thiazolyl)-2-[(2-methyl-r S = peak response from the Standard solution 4-oxo-1-sulfo-3-azetidinyl)amino]-2-oxoethylidene]ami-C S= concentration of USP Aztreonam RS in theno]oxy]-2-methyl-, [2S -[2α,3β(Z )]]-;Standard solution (mg/mL)(Z )-2-[[[(2-Amino-4-thiazolyl)[[(2S ,3S )-2-methyl-4-oxo-C U = concentration of Aztreonam in the Sample1-sulfo-3-azetidinyl]carbamoyl]methylene]amino]oxy]-solution (mg/mL)2-methylpropionic acid [78110-38-0].P = potency of USP Aztreonam RS (µg/mg)F = unit conversion factor, 0.001mg/µgDEFINITIONAcceptance criteria: 92.0%–105.0% on the anhydrous Aztreonam, which may be anhydrous or hydrated, contains and solvent-free basisNLT 92.0% and NMT 105.0% of C 13H 17N 5O 8S 2, calculated on the anhydrous and solvent-free basis.IMPURITIESInorganic ImpuritiesIDENTIFICATION•R ESIDUE ON I GNITION 〈281〉: NMT 0.1%, the charred resi-•I NFRARED A BSORPTION 〈197K 〉: If a difference appears in due being moistened with 2mL of nitric acid and the IR spectra of the analyte and the standard, dissolve 5drops of sulfuric acidequal portions of the test specimen and the reference standard in equal volumes of methanol. [N OTE —To achieve a complete dissolution, it is suggested to use Delete the following:about 25mL of methanol for each 50mg of material,and stir the mixture for 40 min at room temperature.]••H EAVY M ETALS , Method II 〈231〉: NMT 30ppm •(Official 1-Evaporate the solutions to dryness under vacuum, and Jan-2018)dry at 40° for 4 h under vacuum. Perform the test on Organic Impurities the residues.•P ROCEDURE[N OTE —Store the System suitability solution , Standard so-ASSAYlution , and Sample solution at 5°, and protect from light •P ROCEDUREto prevent isomerization of aztreonam Z -isomer to az-[N OTE —Store the System suitability solution , Standard so-treonam E -isomer.]lution , and Sample solution at 5°, and protect from light Mobile phase, System suitability solution, Standard to prevent isomerization of aztreonam Z -isomer to az-solution, Sample solution, Chromatographic system,treonam E -isomer.]and System suitability: Proceed as directed in the Buffer: 6.8mg/mL of monobasic potassium phosphate Assay .in water. Adjust with 1M phosphoric acid to a pH of Analysis3.0.Samples: Standard solution and Sample solutionMobile phase: Methanol and Buffer (1:4)Calculate the percentage of each impurity in the por-System suitability solution: 1mg/mL of USP Aztre-tion of Aztreonam taken:onam RS and 1mg/mL of USP Aztreonam E -Isomer RS in Mobile phaseResult = (r U /r S ) × (C S /C U ) × P × F × 100Standard solution: 1mg/mL of USP Aztreonam RS in Mobile phaser U= peak response of each impurity from theSample solution: 1mg/mL of Aztreonam in Mobile Sample solutionphaser S = peak response of aztreonam from the StandardChromatographic systemsolution(See Chromatography 〈621〉, System Suitability .)C S = concentration of USP Aztreonam RS in theMode: LCStandard solution (mg/mL)Detector: UV 254 nmC U = concentration of Aztreonam in the SampleColumn: 3.9-mm × 30-cm; 10-µm packing L1solution (mg/mL)Flow rate: 1.5mL/min P = potency of USP Aztreonam RS (µg/mg)Injection size: 10µL F = unit conversion factor, 0.001mg/µg System suitabilityAcceptance criteriaSamples: System suitability solution and Standard Individual impurities: See Table 1.solution[N OTE —The relative retention times for aztreonam and aztreonam E -isomer are 1.0 and 1.8, respectively.]。

阿奇霉素 (Azithromycin)使用说明书阿奇霉素 (Azithromycin)使用说明书一、药品名称阿奇霉素（Azithromycin）二、药品成分和含量主要成分：阿奇霉素每片含量：500mg三、适应症阿奇霉素属于广谱抗生素，主要用于治疗以下感染症状：1. 呼吸道感染：如细菌性支气管炎、肺炎等；2. 皮肤和软组织感染：如红斑狼疮、疥疮、蜂窝繁殖等；3. 生殖系统感染：如尿路感染、淋病等；4. 胃肠道感染：如胃炎、胃溃疡等。

四、用法用量1. 通常用量为每天一次，空腹服用或餐后一小时内服用。

2. 成人用量为一次500mg，疗程为3-5天。

3. 儿童患者的用量需根据年龄、体重和病情而定，请咨询医生进行准确剂量确定。

4. 请遵守医生的指导，避免自行调整剂量。

五、使用注意事项1. 对阿奇霉素过敏者禁用，对其它大环内酯类抗生素过敏者慎用。

2. 在使用阿奇霉素期间，如出现过敏反应（如皮疹、荨麻疹、呼吸困难等），应立即停药并就医。

3. 长期使用阿奇霉素会增加细菌耐药性，请按医生规定的疗程和剂量使用，不要滥用或过量使用。

4. 在使用阿奇霉素期间，如出现严重的胃肠道反应（如腹泻、恶心、呕吐等），应减少剂量或停药并就医。

5. 孕妇、哺乳期妇女和儿童患者应在医生指导下使用阿奇霉素。

6. 同时使用抗生素和洗胃药可能会影响药效，请避免同时使用。

7. 阿奇霉素可能会与某些药物发生相互作用，包括但不限于华法林和西咪替丁，请在使用前告知医生当前使用的所有药物。

8. 药物过期后请不要使用，注意储存温度和湿度。

六、不良反应阿奇霉素可能会引起以下不良反应，请在使用期间留意：1. 胃肠道反应：如腹泻、恶心、呕吐等；2. 皮肤反应：如皮疹、荨麻疹等；3. 注意力不集中、头晕、疲劳等。

如出现以上不良反应或其他不适症状，请咨询医生。

七、贮藏1. 请将阿奇霉素储存在原包装中，避免阳光直射。

2. 请放置于儿童无法触及的地方。

八、包装规格阿奇霉素主要以药片的形式销售，每片含500mg阿奇霉素。

阿奇霉素使用说明书一、药品名称阿奇霉素二、成分及含量每片含有阿奇霉素二水合物相当于阿奇霉素250毫克。

三、性状阿奇霉素为白色或类白色结晶性粉末。

四、药理作用阿奇霉素是一种广谱的抗生素，属于大环内酯类药物。

其通过抑制细菌蛋白质的合成来起到抗菌作用。

阿奇霉素对革兰氏阳性菌、革兰氏阴性菌和一些其他细菌具有较广泛的抗菌活性。

五、适应症阿奇霉素适用于治疗下列感染引起的细菌感染：1. 上呼吸道感染（如扁桃体炎、咽炎等）2. 下呼吸道感染（如支气管炎、肺炎等）3. 皮肤和软组织感染（如痈、脓肿等）4. 生殖系统感染（如附件炎、性传播疾病等）5. 消化系统感染（如胃炎、肠炎等）六、用法用量1. 成人常用剂量：一次250毫克，每日2次，疗程一般为5-7天。

2. 儿童常用剂量：视年龄和体重而定，请咨询医生或药师指导。

七、服用方法1. 阿奇霉素可以空腹或饭后服用。

2. 将片剂整片吞服，并配以适量水。

八、注意事项1. 使用阿奇霉素前，请告知医生或药师是否对阿奇霉素过敏。

2. 在使用阿奇霉素期间，如出现过敏反应（如皮疹、荨麻疹等）应停药并及时就医。

3. 妊娠期妇女、哺乳期妇女以及儿童的使用需遵循医生或药师的指导。

4. 阿奇霉素可能与其他药物发生相互作用，在用药期间请避免与其他药物同服，如需同时使用其他药物，请告知医生或药师。

九、不良反应使用阿奇霉素可能会出现以下不良反应：1. 消化系统反应：恶心、呕吐、腹泻等。

2. 皮肤过敏反应：皮疹、荨麻疹等。

3. 噁心、呕吐、腹泻、胃肠道不适、厌食、腹胀、腹痛、黄疸、便秘、胃肠道出血等。

4. 神经系统反应：头痛、晕眩、嗜睡等。

十、贮藏请将阿奇霉素存放在阴凉干燥的地方，避免阳光直射。

十一、包装规格阿奇霉素片剂规格为250毫克。

十二、生产企业本药品由XX制药有限公司生产。

阿奇霉素分散片说明书【药品名称】通用名：阿奇霉素分散片曾用名：商品名：英文名：Azithromycin Dispersible Tablets汉语拼音：Aqimeisu Fensanpian本品主要成份为阿奇霉素，其他学名称为（2R，3S，4R，5R，8R，10R，11R，12S，13S，14R）-13-［（2，6-二脱氧3-C-甲基-3-O-甲基-α-L-核-已吡喃糖基）氧］-2-乙基-3，4，10-三羟基-3，5，6，8，10，12，14-七甲基-11-［［3，4，6-三脱氧-3-（二甲氨基）-β-D-木-已吡喃糖基］氧］-1-氧杂-6-氮杂环十五烷-15酮。

其结构式为：分子式：C38H72N2O18分子量：749.00【性状】本品为白色片。

【药理毒理】阿奇霉素系通过阻碍细菌转肽过程，从而抑制细菌蛋白质的合成，体外试验证明阿奇霉素对临床上多种常见致病菌有抗菌作用，包括：革兰阳性需氧菌：金黄色葡萄球菌、酿脓链球菌（A组B溶血性链球菌）、肺炎（链）球菌、α-溶血性链球菌（草绿色链球菌）和其它链球菌、白喉（棒状）杆菌。

本品对于耐红霉素的革兰阳性细菌，包括粪链球菌（肠球菌）以及耐甲氧西林的多种葡萄球菌菌株呈现交叉耐药性。

革兰阴性需氧菌：流感（嗜血）杆菌、副流感（嗜血）杆菌、卡他（摩拉）菌、不动杆菌属、耶尔森菌属、嗜肺军团菌、百日咳杆菌、副百日咳杆菌、志贺菌属、巴斯德菌属、霍乱弧菌、副溶血性杆菌、类志贺吡邻单胞菌。

本品对下列革兰阴性菌的活性视菌株而定，并需作敏感性测定：大肠埃希菌、伤寒沙门菌、肠肝菌属、亲水性单胞菌、克雷白菌属。

厌氧菌：脆弱类杆菌、类杆菌属、产气荚膜杆菌、消化链球菌属、坏死梭杆菌、痤疮丙酸杆菌。

性传播疾病微生物：梅毒螺旋体、淋病奈瑟菌、杜克（嗜血）杆菌。

其他微生物：包括特南包柔螺旋体（Lyme病体）、肺炎支原体、人型支原体、解脲支原体、沙眼衣原体、卡氏肺孢子虫、鸟分枝杆菌属、弯曲菌属、单核细胞增多性李斯德杆菌。

阿奇霉素分散片的用法用量和作用一、药物简介阿奇霉素分散片是一种常用的抗生素药物，属于大环内酯类抗生素。

其主要成分是阿奇霉素。

阿奇霉素具有广谱抗菌活性，可以有效抑制细菌的生长和繁殖，对多种感染病原体具有杀灭作用。

二、用法用量阿奇霉素分散片一般口服使用，可在饭前或饭后服用，避免与牛奶或果汁一同服用。

服用时可以将药片直接吞服或者将药片溶解于水中后饮用。

1.成人用量：通常建议成人每日一次，一次剂量为500毫克至1000毫克，具体用量应根据医生的建议来确定。

2.儿童用量：儿童用药应根据体重来计算，通常建议儿童每日一次，每千克体重一次剂量为10至20毫克，具体用量应根据医生的建议来确定。

请注意：未成年人和老年人在使用阿奇霉素分散片时，应遵循医生的建议，用量可能会有所调整。

三、作用阿奇霉素分散片具有以下作用和治疗效果：1.治疗细菌感染：阿奇霉素分散片可以用于治疗多种细菌感染疾病，如上呼吸道感染、下呼吸道感染、皮肤软组织感染等等。

它可以抑制细菌的生长和繁殖，达到杀灭细菌的效果。

2.抗炎作用：阿奇霉素分散片在治疗细菌感染的同时，还可以起到一定的抗炎作用。

它能够减轻患者的炎症反应，缓解相关症状，促进病情的好转。

3.用于预防传染病：阿奇霉素分散片还可用于防治某些传染病。

例如，在流行性感冒高发季节或密切接触流感患者时，适当使用阿奇霉素分散片可以预防流感的发生。

4.简便易用：阿奇霉素分散片相对于其他抗生素剂型来说，服用方便。

其分散片剂型容易溶解在水中，不需要嚼碎或配制成混悬液，大大提升了患者的用药便利性。

四、不适用人群阿奇霉素分散片不适用于下列人群：1.对阿奇霉素过敏者：具有阿奇霉素过敏史的个体不应使用本药物，以免引起过敏反应。

2.肝肾功能损害者：肝肾功能受损的患者在使用阿奇霉素分散片前需咨询医生，根据具体情况评估是否适合使用。

3.孕妇和哺乳期妇女：孕妇和哺乳期妇女在使用阿奇霉素分散片前需咨询医生，并按医嘱使用。

请注意：以上所述为一般情况下的注意事项，具体用药还需遵循医生的建议。

阿奇霉素正确服用方法阿奇霉素是一种常用的抗生素药物，用于治疗多种细菌感染疾病，如呼吸道感染、皮肤软组织感染、尿路感染等。

正确使用阿奇霉素对治疗感染疾病非常重要，不仅可以提高疗效，还可以减少药物的不良反应。

下面将介绍阿奇霉素的正确服用方法，希望能对大家有所帮助。

首先，关于用药剂量和频率。

一般情况下，成人每次口服阿奇霉素的剂量为500mg，每日2次，间隔12小时服用。

而儿童的用药剂量通常根据体重来确定，一般为10mg/kg，每日分2次服用。

在服用阿奇霉素时，一定要严格按照医生的建议来用药，不得随意增减剂量或更改用药频率。

其次，关于用药时间。

在使用阿奇霉素时，一定要按照医生的建议来完成整个疗程，不得擅自停药或中途更换其他药物。

即使症状有所好转，也不能因此而停止用药，否则容易导致细菌耐药性的产生，甚至引发感染的复发。

一般情况下，成人使用阿奇霉素的疗程为5-14天，而儿童的疗程则根据具体情况而定。

此外，关于用药时间。

阿奇霉素通常是空腹服用，即饭前或饭后2小时服用，以便提高药物的吸收率。

在服用阿奇霉素时，最好避免与奶制品一同服用，因为奶制品中的钙离子会影响阿奇霉素的吸收。

另外，阿奇霉素片剂应该整片吞服，并且要足量饮水送服，以免药物滞留在食道内引起不适。

最后，关于注意事项。

在使用阿奇霉素期间，应该密切关注自身的身体状况，如出现过敏反应、消化道不适等症状，应及时就医。

同时，应避免饮酒，以免影响药物的疗效。

另外，患有肝肾功能不全的患者在使用阿奇霉素时应当谨慎，最好在医生的指导下使用。

总之，正确使用阿奇霉素对治疗感染疾病非常重要，只有严格按照医生的建议来用药，才能提高疗效，减少不良反应的发生。

希望大家在使用阿奇霉素时能够注意上述事项，保证用药的安全和有效性。

阿奇霉素的使用方法
阿奇霉素是一种抗生素药物，常用于治疗呼吸道、皮肤及软组织感染等疾病。

以下是阿奇霉素的使用方法：
1. 用药前请遵循医生的嘱托，并严格按照药品说明书上的用法用量进行使用。

2. 阿奇霉素通常以片剂、颗粒剂或胶囊剂的形式供应。

使用前请确保包装完好，并注意查看药品的有效期。

3. 阿奇霉素片剂一般需要口服，最好在饭后服用。

请用充足的水将药片吞下，避免咬碎或嚼服。

4. 阿奇霉素颗粒剂使用前需要与指定的稀释剂（如开水）进行稀释。

可根据儿童的体重来确定适当的用量。

将稀释后的药液分次服用。

5. 阿奇霉素胶囊剂可直接口服，也需要用充足的水吞服，不建议与酸性饮料一同服用。

6. 在用药期间，请遵循医生的指示完成全程治疗，不要随意中断或更改用药剂量。

7. 如果不慎忘记一次用药，请尽快补上，在下一次用药时间之前不要将两次剂量一起服用。

8. 注意药物的不良反应，如出现过敏反应、皮疹、恶心呕吐或
腹泻等不适症状，应及时咨询医生。

请注意，以上提供的信息仅供参考，请在使用阿奇霉素前务必咨询医生或药剂师的意见，并严格按照医嘱进行使用。