Ciprofloxacin Tablets(环丙沙星片)USP40
环丙沙星
环丙沙星英文名：Ciprofloxacin分子式：C17H18FN3O3化学名称：1-环丙基-6-氟-1,4-二氢-4-氧代-7-（1-哌嗪基）-3-喹啉羧酸11药学王一凡11071031药典药典是通过建立国家技术标准来保证人类和牲畜使用的药物的质量、剂量和药物纯度和浓度标准的权威性出版物。
它是在专业的，通常是政府的权威人士的监督下进行编辑，并且是所药物的制造、分配和药物治疗所必须遵照的标准。
目前常用的药典标准有英国药典（BP）、欧洲药典（EP）、美国药典（USP）、德国药典（DAP）、日本药典（JP）、中国药典（CP）。
用途该品属高效广谱抗菌药。
药理作用属氟喹诺酮类，抗菌谱同诺氟沙星，其抗菌活性是目前广泛应用的氟喹诺酮类中最强者。
除对革兰阴性杆菌有高度抗菌活性外，尚对葡萄球菌属具有良好抗菌作用，对肺炎球菌、链球菌属的作用略差于葡萄球菌属。
该品对部分分枝杆菌、沙眼衣原体、溶脲脲原体、人型支原体等亦具抑制作用。
该药的作用机制及细菌耐药情况参见诺氟沙星。
为杀菌剂，现一般认为喹诺酮类作用于细菌细胞DNA螺旋酶的A亚单位，抑制DNA的合成和复制而导致细菌死亡。
适应症环丙沙星的临床用途较诺氟沙星为广，除尿路感染、肠道感染、淋病等外，尚可用以治疗由流感杆菌、大肠杆菌、肺炎杆菌、奇异变形杆菌、普通变形杆菌、普罗菲登菌、摩根杆菌、绿脓杆菌、阴沟肠杆菌、弗劳地枸橼杆菌、葡萄球菌属（包括耐甲氧西林株）等引起的骨和关节感染、皮肤软组织感染和肺炎、败血症等。
该品口服制剂的适应证同诺氟沙星；静脉给药可用于较重感染的治疗，如肠杆菌科细菌败血症、肺部感染、腹腔、胆道感染等。
性状本品为白色至微黄色结晶性粉末；几乎无臭，味苦。
本品在醋酸中溶解，在乙醇和三氯甲烷中极微溶解，在水中几乎不溶。
鉴别在含量测定项下记录的色谱图中，供试品溶液主峰的保留时间应与对照品溶液主峰的保留时间一致。
本品的红外光吸收图谱应与对照的图谱（光谱集979图）一致。
Ciprofloxacin Hydrochloride 盐酸环丙沙星质量标准英文
Ciprofloxacin HydrochlorideC17H18FN3O3·HCl·H2O 385.82The product is 1- Cyclopropyl -6-fluoro-1, 4 -dihydro- 4 -oxo- 7- (1 -piperazinyl)- 3 -quinolinecarboxylic acid·hydrochloride·monohydrate. It contains not less than 88.5% C17H18FN3O3 calculated on the anhydrous basis.DescriptionA white to slightly yellow crystalline powder; almost odourless; bitter in taste. Soluble in water, slightly soluble in methanol or ethanol, almost insoluble in acetic ether or methylene dichloride.Identification(1) Dissolve a quantity of Ciprofloxacin Hydrochloride and Ciprofloxacin Hydrochloride RS in a quantity of 0.1mol/L Hydrochloride solution separately (every 5 mg Ciprofloxacin Hydrochloride add 1 ml Hydrochloride solution), and dilute them with ethanol to obtain a test solution containing 1 mg per ml and a standard solution containing 1 mg per ml. Dissolve a quantity of Ciprofloxacin Hydrochloride RS and Ofloxacin RS in a quantity of 0.1 mol/L Hydrochloride solution separately (every 5 mg Ciprofloxacin Hydrochloride add 1 ml Hydrochloride solution), and dilute them with ethanol to obtain a system suitability test solution containing 1 mg Ciprofloxacin Hydrochloride and 1 mg Ofloxacin per ml. Carry out the method of TLC as described under the CP( AppendixⅤB)，separately apply 2 l each of the three solutions above to a TLC silica gel F254 plate R, and develop the chromatogram in a solvent system consisting of a mixture of ethyl acetate, methanol and concentrated Ammonia Solution(5:6:2), until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the chamber and allow the plate to air-dry. Examine the plate in ultraviolet light at 254nm or 365nm. The location and color of the principal band obtained from the test solution corresponds to that obtained from thestandard solution.(2) The retention time of principal peak of the test solution being examined in the chromatogram obtained in the Assay is identical with that of Ciprofloxacin Hydrochloride CRS.(3) The infrared absorption spectrum is concordant with the reference spectrum of Ciprofloxacin Hydrochloride CRS.(4) A solution of it responds to the tests for Chloride (Appendix Ⅲ).Choose one from (1) and (2).DetectionPH An aqueous solution of 25mg per ml, PH 3.0~4.5( AppendixⅥ H).Clarity and colour of solution Dissolve 1.0g of the substance in 10 ml of water, the solution is clear; any colour produced is not more intense than that of reference solution Y4 or YG4(Appendix ⅨA).Related substanceDissolve a accurately weighed quantity of the substance in mobile phase A and dilute to obtain a test solution containing 0.5mg per ml; dilute a quantity of Ciprofloxacin Hydrochloride CRS with mobile phase A to obtain a reference solution containing 1μg per ml. Dissolve 15 mg of Impurity A RS in a mixture of 0.6ml of 6 mol/L ammonia solution and a quantity of water in a 100 ml flask, dilute to volume with water and mix well. Dilute 1 ml of the solution to100ml with mobile phase A and mix well, take it as the Impurity A CRS. Carry out the method for HPLC (Appendix ⅤD), using a column packed with octadecylsilane bonded silica, a mixture of 0.025mol/L phosphoric acid solution- acetonitrile(87:13) ( adjusted to PH 3.0±0.1 with triethylamine) as the mobile phase A, acetonitrile, gradiently elute as mobile phase B with flow rate of 1.5ml per min according to the table below.Dissolve a quantity of Ofloxacin CRS, Ciprofloxacin Hydrochloride CRS and ImpurityⅠCRS in mobile phase A and dilute to obtain a mixture of 5μg of Ofloxacin CRS, 0.5mg of Ciprofloxacin Hydrochloride CRS and 10μg of Impurity ⅠCRS. Inject 20μl of the mixture solution into the chromatograph, take 278nm asdetection wavelength, and record the chromatogram, the retention time for the peak of Ciprofloxacin Hydrochloride is about 12 minutes. The resolution factor between the peaks of Ofloxacin, Ciprofloxacin Hydrochloride and ImpurityⅠcomplies with the related requirements. Inject 20μl of the reference solution into the chromatograph, take 278nm as detection wavelength, adjust the detection sensitivity to make the peak of main ingredient be about 20% of the sum of all the peaks.Inject 20μl of test solution, the reference solution and the impurity A CRS into the chromatograph, take 278nm and 262nm as detection wavelength, and record the chromatogram, the retention time for the peak of Ciprofloxacin Hydrochloride is 1, for impurity E, B, C, I, and D are separately 0.3, 0.6, 0.7, 1.1 and 1.2. The area of the peak in the chromatogram obtained with impurity A CRS (detected under 262nm) is not more than 0.3% calculated on peak area by external standard method.The areas of the peak in the chromatogram obtained with Impurity B, C, D and E (detected under 262nm) should not more than those of the principal peak obtained with reference solution(0.2%) calculated on peak area after correction (multiply correction factor of 0.7, 0.6, 1.4 and 6.7). The area of the peak in the chromatogram obtained with any other impurity (detected under 278nm) should not more than that of the peak obtained with reference solution (0.2%). The sum of all the impurity area after correction is not more than 3.5 times the area of the principal peak in the chromatogram obtained with the reference solution (0.7%). Disregard any peak obtained with the test solution that is less than 0.1 time the area of the principal peak in the chromatogram obtained with the reference solution.Toluene and ethanolDissolve 0.2g of the product accurately weighed to a h eadspace Vial in 5 ml of water,well closed, as the test solution; Measure accurately a quantity of Toluene and ethanol, and dilute with water to obtain a solution containing 0.05mg Toluene and 0.1mg of ethanol per ml. measure accurately 5 ml into headspace vial, well closed, as the reference solution. Carry out the method for determination of residual solvents (AppendixⅧP),using a capillary column closed with 5% phenyl-95% methylpolysiloxane(or with the similar polarity stationary phase), maintaining the temperature of the column at 50℃, the incubation time of headspace temperature of headspace oven is 90℃, the incubation time of headspace vial is 30 min.Inject the reference solution to the headspace vial, record the chromatogram. The resolution between the peaks of Toluene and ethanol comply with the requirement. Inject the test and reference solution to the headspace vial, record the chromatogram. Calculate the content of toluene and ethanol respectively with respect to the peak area obtained in the chromatogram by external standard method, the result complies with the related requirements.Water 4.7%~6.7%( Appendix Ⅷ M, method 1 A)Residue on ignition Not more than 0.1%( Appendix Ⅷ N), using 1.0g.Heavy metals Carry out the limit test for heavy metals (Appendix Ⅷ H, method 2), using the residue obtained in the test for Residue on ignition: not more than 0.002%. Assay Carry out the method for high performance liquid chromatogram (Appendix ⅤD)Chromatographic and system suitabilityUsing a column packed with octadecylsilane bonded silica and a mixture of 0.025mol/L phosphoric acid solution-acetonitrile(87:13) as the mobile phase previously adjusted to pH 3.0±0.1 with triethylamine. The detection wavelength is 278nm and the flow rate of mobile phase is 1.5ml per min.Dissolve a quantity of Ofloxacin CRS, Ciprofloxacin Hydrochloride CRS and Impurity 1 CRS in mobile phase and dilute to obtain a mixture of 5μg of Ofloxacin CRS, 0.1mg of Ciprofloxacin Hydrochloride CRS and 10μg of Impurity 1 CRS. Inject 20μg to the Chromatograph, and record the chromatogram, the retention time of Ciprofloxacin Hydrochloride area is about 12 minutes, the resolution between Ciprofloxacin Hydrochloride area and Ofloxacin area complies with the requirement.Procedure Dissolve an accurately weighed quantity in mobile phase to obtain a solution of about 0.1mg per ml. Inject 20 l of the solution to the column, record the chromatogram; Repeat the operation, using ciprofloxacin CRS instead of the substance being examined. Calculate the content of C17H18FN3O3 with respect to the peak area obtained in the chromatogram by external standard method.Category Carbostyril antibioticStorage Preserve in tightly closed containers, protected from light.。
环丙沙星 别名：丙氟哌酸,悉复欣、环丙氟哌酸、悉复欢、适
inhibited DNA synthesis and replication and the bacterial cause of death. The role and use 【】 Synthetic product is the third generation quinolone antibacterial drug with broad-spectrum antibacterial activity, bactericidal effect well, almost all bacteria antibacterial activity than norfloxacin and enoxacin strong 2 ~ 4 times that of the Enterobacteriaceae, Pseudomonas aeruginosa, Haemophilus influenzae, Neisseria gonorrhoeae, Streptococcus, Legionella, Staphylococcus aureus with antimicrobial activity. Mainly used in clinical 敏感菌-induced respiratory tract, urinary tract, digestive tract, such as skin and soft tissue infections and cholecystitis, cholangitis, otitis media, sinusitis, such as gonococcal urethritis. Of methicillin-resistant Staphylococcus aureus (MRSA) infections caused by vancomycin resistance should not, and optional 用本品 as a combined one. 【Usage】 dose and Oral, adult 0.2g / time, 2 ~ 3 times / day; also use for 0.5g ~ 0.75g / times, 1 times / 12 hours. Infusion, 0.1g ~ 0.2g / times, 2 times / day can be normal saline or glucose injection dilution, infusion time of not less than 30 minutes. 【Formulations and specifications 】 1 tablet: Each tablet marked volume calculated by ciprofloxacin 250mg; 500mg; 750mg (1 permanganate salt hydrates respectively 291,582 or 873mg). Injection 2: Each 100mg (50ml); 200mg (100ml) (containing lactate were 127.2 or 254.4mg). Side effects 【】 One common are nausea, abdominal pain and diarrhea on areas such as. 2 has a headache, irritability, and skin rash. 3 for the goods allergy disabled, pregnant women, lactating women and children used with caution.
盐酸环丙沙星阴道泡腾片
盐酸环丙沙星阴道泡腾片【药品名称】通用名称：盐酸环丙沙星阴道泡腾片英文名称：Ciprofloxacin Hydrochloride Vaginal Effervescent Tablets【成份】盐酸环丙沙星。
【适应症】适用于细菌性阴道病和淋菌性宫颈阴道炎。
【用法用量】阴道给药，患者用药前清洁外阴部后，取仰卧位，将本品置入阴道深部。
每晚一次，每次1片，七天为一疗程。
【不良反应】使用本品偶有阴道不适感、烧灼感、下坠感、疼痛、水肿等。
【禁忌】对本品及喹诺酮类药物过敏者禁用。
【注意事项】孕妇及哺乳期妇女不宜使用。
【特殊人群用药】儿童注意事项：尚不明确。
妊娠与哺乳期注意事项：孕妇及哺乳期妇女不宜使用。
老人注意事项：尚不明确。
【药物相互作用】尚不明确。
【药理作用】作用机制为抑制细菌DNA螺旋酶。
具有广谱抗菌作用，对大肠杆菌、克雷伯菌和其它肠杆菌科阴性杆菌以及流感杆菌、伤寒杆菌、痢疾杆菌、淋球菌具有较强抗菌活性，对绿脓杆菌、不动杆菌、金黄色葡萄球菌以及肺炎双球菌、甲型溶血链球菌、乙型溶血链球菌等抗菌作用亦优于氟哌酸、甲磺酸培氟沙星，但对肺炎球菌及A组链球菌作用甚微。
与其它抗生素无交叉耐药性，β-内酰胺类、氨基糖苷类、磺胺类耐药菌株对本品仍敏感。
【贮藏】遮光，密闭，置阴凉干燥处保存。
【有效期】24个月【批准文号】国药准字H10980197【生产企业】企业名称：辽宁美大康华邦药业有限公司生产地址：沈阳市沈北新区兴农路26号。
环丙沙星正确用法与注意事项
环丙沙星正确用法与注意事项环丙沙星是一种广谱抗生素，常用于治疗各种感染疾病。
然而，正确的用法和注意事项对于保证药效和避免不良反应非常重要。
本文将对环丙沙星的正确用法和注意事项进行详细介绍。
一、环丙沙星的正确用法1. 按照医生的指导使用：在使用环丙沙星之前，务必咨询医生并按照医嘱使用。
医生会根据病情和个体差异来确定剂量和疗程。
2. 遵守用药时间：环丙沙星通常建议在饭前或饭后2小时内使用。
此外，用药时间间隔要均匀分布，并保持相同的间隔时间。
3. 避免漏服和超量：确保每日按时服用环丙沙星，并避免漏服或超量。
如果忘记服药，可以在尽快想起的时候立即补服，但不要与下一剂相重叠。
4. 方式和剂量：环丙沙星可以口服或静脉滴注。
剂量取决于个体差异和病情，应根据医生的建议准确使用。
5. 不得随意停药：即使症状缓解，也不能擅自停药。
应该完成整个疗程，以充分消灭感染病菌。
二、环丙沙星的注意事项1. 避免与其他药物相互作用：在使用环丙沙星期间，应避免与铁剂、牛奶、抗酸药物等同时使用，以免影响吸收效果。
同时，还应注意避免与抗凝药物、降血糖药物等同时使用，以免发生不良反应或影响药效。
2. 注意饮食与水分摄入：在使用环丙沙星期间，应保持足够的水分摄入，以增加尿量，有助于排出代谢物。
另外，应避免摄入过多的咖啡因、酒精等刺激性物质，以免对肾脏产生不利影响。
3. 注意药物过敏反应：在使用环丙沙星期间，如果出现过敏反应，如皮疹、瘙痒、呼吸困难等，请立即停药并就医。
4. 注意肝肾功能：环丙沙星主要通过肝脏和肾脏代谢，因此在使用期间应监测肝肾功能，特别是对于老年人、肝肾功能受损者需格外注意。
5. 注意不良反应：环丙沙星的常见不良反应包括胃肠道反应（如恶心、呕吐、腹泻），神经系统反应（如头痛、头晕、失眠）等。
如果出现严重的不良反应，应及时就医。
总结：正确使用环丙沙星是确保其疗效和安全性的关键。
遵守医生的指导，按时按量使用药物；注意避免药物相互作用和饮食摄入；监测肝肾功能；注意不良反应。
西普乐(环丙沙星片)
西普乐(环丙沙星片)
【药品名称】
商品名称：西普乐
通用名称：环丙沙星片
英文名称：Ciprofloxacin Tablets
【适应症】
用于敏感菌引起的：1.泌尿生殖系统感染，包括单纯性、复杂性尿路感染、细菌性前列腺炎、淋病奈瑟菌尿道炎或宫颈炎(包括产酶株所致者)。
2.呼吸道感染，包括敏感革兰阴性杆菌所致支气管感染急性发作及肺部感染。
3.胃肠道感染，由志贺菌属、沙门菌属、产肠毒素大肠埃希菌、亲水气单胞菌、副溶血弧菌等所致。
4.伤寒。
5.骨和关节感染。
6.皮肤软组织感染。
7.败血症等全身感染。
【批准文号】
H20110548。
供应一致性评价盐酸环丙沙星片原研参比制剂一次性进口
中文名称：盐酸环丙沙星片
英文名称：Ciprofloxacin Hydrochloride Tablets/Ciprobay
规格：0.25g 0.5g
剂型：片剂
持证商:Bayer Vital GmbH
备注：原研进口,进口产品现名为环丙沙星片。
卓越生物现可以提供欧美、日本、澳大利亚等国家的原研参比制剂一次性进口服务，可代理清关，具有价格优势大、货期快、服务周到等优点。
可代理清关，可提供原厂地证明，可用于一致性评价。
卓越生物全面提供药物杂质对照品、标准品、原研药参比剂、转基因产品。
旗下公司代理LGC、Cerlliant、EP、TRC、TLC、MC、JP、中检所、USP、AOCS等数十个品牌。
卓越生物同时为您新药开发提供全方位的咨询服务！。
环丙沙星片的用药指导
环丙沙星片的用药指导环丙沙星片（Ciprofloxacin Tablets）是一种广谱的抗菌药物，常用于治疗各种感染疾病。
本文将重点介绍环丙沙星片的用药指导，以帮助患者正确、安全地使用该药物。
一、药物的适应症环丙沙星片适用于下列感染疾病的治疗：1. 呼吸道感染：如肺炎、支气管炎等；2. 泌尿生殖系统感染：如尿路感染、前列腺炎等；3. 骨关节感染：如骨髓炎、关节感染等；4. 皮肤软组织感染：如蜂窝织炎、糖尿病足等；5. 消化道感染：如胃肠炎、胃溃疡等；6. 耳鼻喉感染：如中耳炎、扁桃体炎等。
二、用药注意事项1. 使用说明：①请按照医生的指导或药品说明书上的用法用量进行用药；②首次使用药物前，请仔细阅读药品说明书，了解使用方法和注意事项。
2. 用药时间：①请定时服药，按时按量服用；②未完成疗程不得随意停药，即便症状好转也应依医嘱完整使用。
3. 饭前或餐后：①通常建议饭前一小时或餐后两小时服用，以充分发挥药物的疗效；②特殊情况下，请遵循医生的具体指导。
4. 药物不良反应：①使用环丙沙星片可能引起恶心、呕吐、腹泻等胃肠道反应；②如出现皮疹、过敏反应、心律失常等不良反应，请立即就医。
5. 孕妇及哺乳期妇女慎用：①孕妇、哺乳期妇女请在医生指导下使用；②若出现不适，应立即咨询医生。
6. 与其他药物的相互作用：①患者在使用环丙沙星片期间，请告知医生其他正在使用的药物；②需避免与镁铝抗酸药和铁剂同时使用，以免降低药效。
7. 保管注意事项：①请将药物存放在儿童无法触及的地方；②避免阳光直射，存放在阴凉干燥处。
三、用药常见问题解答1. 如果漏服了一剂药怎么办？如果是在饭前用药，距离下一顿饭时间还有一段时间，可以立即服用；如果已经过了时间，直接等待下一次用药即可。
如果是在餐后用药，漏服了一剂，可以尽快补服。
2. 药物能否与乳制品一起服用？请勿与乳制品一起服用，以免影响药物的吸收。
3. 哪些人不适合使用环丙沙星片？孕妇、哺乳期妇女、12岁以下儿童、药物过敏者以及存在肝肾功能障碍的患者应避免使用环丙沙星片。
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3432Ciprofloxacin / Official MonographsUSP 40IDENTIFICATION•USP R EFERENCE S TANDARDS 〈11〉• The retention time of the major peak of the Sample solu-USP Ciprofloxacin Ethylenediamine Analog RStion corresponds to that of the Standard solution , as ob-1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-[(2-ami-tained in the Assay .noethyl)amino]-3-quinolinecarboxylic acid hydrochloride.ASSAYC 15H 16FN 3O 3·HCl 341.77•P ROCEDUREUSP Ciprofloxacin Hydrochloride RSSolution A: 0.005 M tetrabutylammonium phosphate solution. Adjust with phosphoric acid to a pH of 2.0.Mobile phase: Methanol and Solution A (1:3)Standard solution: 0.14mg/mL of USP Ciprofloxacin Hydrochloride RS in waterCiprofloxacin TabletsSystem suitability solution: 0.01mg/mL of USP Ciprofloxacin Ethylenediamine Analog RS in Standard DEFINITIONsolutionCiprofloxacin Tablets contain Ciprofloxacin Hydrochloride Sample solution: Equivalent to 0.12mg/mL of equivalent to NLT 90.0% and NMT 110.0% of the labeled ciprofloxacin from Ophthalmic Solution, in water amount of ciprofloxacin (C 17H 18FN 3O 3).Chromatographic system(See Chromatography 〈621〉, System Suitability .)IDENTIFICATIONMode: LCThe retention time of the major peak of the Sample solution Detector: UV 280 nmcorresponds to that of the Standard solution , as obtained Column: 4.6-mm × 25-cm; packing L1in the Assay .Flow rate: 1.5mL/min Injection size: 20µL ASSAYSystem suitability•P ROCEDURESamples: Standard solution and System suitability Solution A: 0.025 M phosphoric acid. Adjust with tri-solutionethylamine to a pH of 2.0 ± 0.1.[N OTE —The relative retention times for the ciprofloxacin Solution B: Acetonitrile and Solution A (13:87)ethylenediamine analog and ciprofloxacin are 0.8 and Solution C: 0.025 M phosphoric acid. Adjust with tri-1.0, respectively.]ethylamine to a pH of 3.0 ± 0.1.Suitability requirementsMobile phase: Acetonitrile and Solution C (13:87)Resolution: NLT 1.5 between the ciprofloxacin ethyl-Standard solution: 0.2mg/mL of USP Ciprofloxacin enediamine analog and ciprofloxacin, System suitabil-Hydrochloride RS in Solution Bity solutionSystem suitability solution: 0.05mg/mL of USPCapacity factor: 1.5–6 for the ciprofloxacin peak,Ciprofloxacin Ethylenediamine Analog RS in the Stan-Standard solutiondard solutionColumn efficiency: NLT 500 theoretical plates, Stan-Sample solution: Transfer 5 Tablets to a 500-mL volu-dard solutionmetric flask, add 400mL of Solution B , and sonicate for Tailing factor: 0.9–2.0, Standard solutionabout 20 min. Dilute with Solution B to volume, mix,Relative standard deviation: NMT 2%, Standard and pass through a membrane filter of 0.45-µm pore solution size. Prepare the equivalent of 0.20mg/mL of ciproflox-Analysisacin from the filtrate with Solution B .Samples: Standard solution and Sample solution Chromatographic systemCalculate the percentage of the labeled amount of (See Chromatography 〈621〉, System Suitability .)C 17H 18FN 3O 3 in the portion of Ophthalmic Solution Mode: LCtaken:Detector: UV 278 nmColumn: 4.6-mm × 25-cm; packing L1Result = (r U /r S ) × (C S /C U ) × (M r1/M r2) × 100Column temperature: 30±1°Flow rate: 1.5mL/min r U = peak response from the Sample solution Injection size: 10µL r S = peak response from the Standard solution System suitabilityC S= concentration of USP CiprofloxacinSamples: Standard solution and System suitability Hydrochloride RS in the Standard solution solution(mg/mL)[N OTE —The retention time for ciprofloxacin is 6.4–10.8C U = nominal concentration of ciprofloxacin in themin. The relative retention times for ciprofloxacin eth-Sample solution (mg/mL)ylenediamine analog and ciprofloxacin are 0.7 and M r1= molecular weight of ciprofloxacin, 331.34 1.0, respectively.]M r2= molecular weight of anhydrous ciprofloxacinSuitability requirementshydrochloride, 367.81Resolution: NLT 6 between the ciprofloxacin ethyl-Acceptance criteria: 90.0%–110.0%enediamine analog peak and the ciprofloxacin peak,System suitability requirementsSPECIFIC TESTS Column efficiency: NLT 2500 theoretical plates from •P H 〈791〉: 3.5–5.5the ciprofloxacin peak, Standard solution•S TERILITY T ESTS 〈71〉: It meets the requirements when Tailing factor: NMT 2.0 for the ciprofloxacin peak,tested as directed under Test for Sterility of the Product to Standard solutionBe Examined, Membrane Filtration .Relative standard deviation: NMT 1.5%, Standard solution ADDITIONAL REQUIREMENTSAnalysis•P ACKAGING AND S TORAGE : Preserve in tight containers,Samples: Standard solution and Sample solutionprotected from light, at room temperature.Calculate the percentage of C 17H 18FN 3O 3 in the portion of Tablets taken:Result = (r U /r S ) × (C S /C U ) × (M r1/M r2) × 100r U= peak response from the Sample solutionUSP 40Official Monographs / Ciprofloxacin3433r S= peak response from the Standard solution Sample stock solution: Nominally 0.5mg/mL in MobileC S= concentration of USP Ciprofloxacin phase prepared as follows. Transfer an equivalent toHydrochloride RS in the Standard solution250mg of ciprofloxacin from finely powdered Tablets(mg/mL), calculated on the anhydrous basis(NLT 20) to a 500-mL volumetric flask. Add 400mL ofC U= nominal concentration of ciprofloxacin in the Mobile phase, place on a rotary shaker for 15 min, andSample solution (mg/mL)sonicate for 25 min. Allow the solution to cool to room M r1= molecular weight of ciprofloxacin, 331.34temperature, and dilute with Mobile phase to volume.M r2= molecular weight of anhydrous ciprofloxacin Pass a portion of the solution through a suitable filter of hydrochloride, 367.810.45-µm pore size.Acceptance criteria: 90.0%–110.0%Sample solution: Nominally 0.05mg/mL of ciproflox-acin in water from Sample stock solution PERFORMANCE TESTS Chromatographic system•D ISSOLUTION〈711〉(See Chromatography 〈621〉, System Suitability.) Medium: 0.01 N hydrochloric acid; 900mL Mode: LCApparatus 2: 50 rpm Detector: UV 278 nmTime: 30 min Column: 4.6-mm × 25-cm; 5-µm packing L1Sample solution: Pass a portion of the solution under Column temperature: 30°test through a suitable filter. Dilute with Medium, if Flow rate: 1.5mL/minnecessary.Injection volume: 10µLStandard solution: USP Ciprofloxacin Hydrochloride RS System suitabilityin Medium Samples:System suitability solution and Standard Spectrometric conditions solution(See Ultraviolet-Visible Spectroscopy 〈857〉.)Suitability requirementsMode: UV Resolution: NLT 6 between the ciprofloxacin and Analytical wavelength: 276 nm ciprofloxacin ethylenediamine analog peaks, System Analysis suitability solutionSamples:Sample solution and Standard solution Tailing factor: NMT 4.0 for the ciprofloxacin peak, Tolerances: An amount of ciprofloxacin hydrochloride System suitability solution(C17H18FN3O3·HCl) equivalent to NLT 80% (Q) of the Relative standard deviation: NMT 2.0% for the labeled amount of ciprofloxacin (C17H18FN3O3) is ciprofloxacin peak, Standard solutiondissolved.Analysis•U NIFORMITY OF D OSAGE U NITS〈905〉: Meet the Samples:Standard solution and Sample solution requirements Calculate the percentage of the labeled amount ofciprofloxacin (C17H18FN3O3) in the portion of Tablets ADDITIONAL REQUIREMENTS taken:•P ACKAGING AND S TORAGE: Preserve in well-closedcontainers.Result = (rU/r S) × (C S/C U) × (M r1/M r2) × 100•USP R EFERENCE S TANDARDS〈11〉USP Ciprofloxacin Ethylenediamine Analog RS rU= peak response of ciprofloxacin from the 1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-[(2-ami-Sample solutionnoethyl)amino]-3-quinolinecarboxylic acid rS= peak response of ciprofloxacin from the hydrochloride.Standard solutionC15H16FN3O3·HCl341.77CS= concentration of USP Ciprofloxacin USP Ciprofloxacin Hydrochloride RS Hydrochloride RS in the Standard solution(mg/mL)C U= nominal concentration of ciprofloxacin in theSample solution (mg/mL)M r1= molecular weight of ciprofloxacin, 331.34 Ciprofloxacin Extended-Release Tablets M r2= molecular weight of anhydrous ciprofloxacinhydrochloride, 367.81Acceptance criteria: 90.0%–110.0%DEFINITIONCiprofloxacin Extended-Release Tablets contain NLT 90.0%PERFORMANCE TESTSand NMT 110.0% of the labeled amount of ciprofloxacin•D ISSOLUTION〈711〉(C17H18FN3O3).Test 1Medium: pH 4.5 acetate buffer (transfer 3g of sodium IDENTIFICATIONacetate and 14mL of 2N acetic acid to a 1-L volumet-•A. The retention time of the major peak of the Sampleric flask, and dilute with water to volume); 900mL, solution corresponds to that of the Standard solution, asdeaeratedobtained in the Assay.Apparatus 2: 50 rpmASSAY Times: 30, 60, and 120 min•P ROCEDURE Standard solution: 6.5µg/mL of USP Ciprofloxacin Buffer: Dilute 2.9mL of phosphoric acid in water to Hydrochloride RS in Medium1000mL. Adjust with triethylamine to a pH of 3.0.Sample solution: Pass a portion of the solution under Mobile phase: Acetonitrile and Buffer (135:865)test through a suitable filter of 0.45-µm pore size. For System suitability solution: 0.58mg/mL of USP500-mg Tablets, transfer 2mL of the filtrate to a Ciprofloxacin Hydrochloride RS and 0.5mg/mL of USP200-mL volumetric flask, and dilute with Medium to Ciprofloxacin Ethylenediamine Analog RS in Mobile volume. For 1000-mg Tablets, transfer 1mL of the fil-phase trate to a 200-mL volumetric flask, and dilute with Me-Standard stock solution: 1.16mg/mL of USP dium to volume. Replace the aliquots withdrawn for Ciprofloxacin Hydrochloride RS in Mobile phase analysis with fresh portions of Medium.Standard solution: 0.058mg/mL of USP CiprofloxacinHydrochloride RS in Mobile phase from Standard stocksolution。