美国药典-头孢曲松钠-中英文对照

1、Ceftriaxone Sodium(USP32)Ceftriaxone sodium contains the equivalent of not less than 795ug of ceftriaxone per mg,calculated on the anhydrous(无水的) basis.本品按无水物计算，每毫克头孢曲松钠含头孢曲松不得少于795微克。Packaging and storage-preserve in the tight containers.包装和贮藏-贮藏于密闭容器中。Labeling（标签）-where it is intended for use in p

2、reparing injectable(血管注射剂，可注射的) dosage（剂量，用量） forms（注射剂型）, the label states that it is sterile（无菌的） or must be subjected to further processing during the preparation of injectable dosage forms.标签-当预期用于注射剂时，标签应说明无菌或者必须可以用于制备注射剂的后续处理。USP Reference standards<11>-USP Ceftriaxone Sodium RS(对照品).标准品

3、USP Ceftriaxone sodium E-Isomer（反式同分异构体） RS.USP Endotoxin（内毒素） RS.Identification-A:Infrared Absorption<197K>B:The chromatogram(色谱图) of the Assay preparation（含量测定溶液） obtained as directed in the assay（含量测定项下的） exhibits（显示） a major peak for ceftriaxone, the retention time（保留时间） of which correspon

4、ds to（相当于） that exhibits in the chromatogram of the Standard preparation obtained as directed in the assay.含量测定项下的含量测定溶液的色谱图中头孢曲松主峰的保留时间和含量测定项下的标准溶液的色谱图中头孢曲松主峰保留时间相一致。C:It responds to the test for Sodium、。显钠盐反应。Crystallinity(结晶度) <695>:meets the requirements.符合规定（要求）Ph<791>:between 6.0 a

5、nd 8.0 in a solution (1in 10).溶液pH值需在6.0到8.0之间（1/10）。Water,Method I<921>:between 8.0%and 11.0%.水分，方法I：需在8.0%到11.0%之间。Other requirements-Where the label states that ceftriaxone sodium is sterile（无菌的）, it meets the requirements for Sterility（无菌） and Becterial endotoxins（细菌内毒素） under Ceftriaxone

6、for injection（注射用头孢曲松）.Where the label states that Ceftriaxone Sodium must be subjected to further processing during the preparation of injectable dosage forms,it meets the requriments for bacterial endotoxins under Ceftriaxone for infection.其他规定-当标签说明头孢曲松钠是无菌时，应满足注射用头孢曲松项下的无菌和细菌内毒素的规定。当标签说明头孢曲松钠在制备

7、注射剂的过程中，需进行后续处理时。它应该满足注射用头孢曲松项下的细菌内毒素的规定。Assay- pH7.0 buffer-Dissolve 13.6g of dibasic potassium phosphate and 4.0g of monobasic potassium phosphate in water to obtain 1000ml of solution,Adjust this soluton with phosphoric acid or 10N potassium hydroxide to a pH of 7.0+-0.1.pH7.0缓冲液-取13.6g的磷酸氢二钾和4.0

8、g的磷酸氢一钾溶于水中并稀释至1000ml溶液，加入磷酸或者是10mol/l的氢氧化钾调节溶液pH值为（7.0+-0.1）.pH5.0 buffer-dissolve 25.8g of sodium citrate in 500ml of water, adjust with citric acid solution (1 in 5) to a pH of 5.0+-0.1,and dilute with water to a volume of 1000ml.pH5.0缓冲液-取25.8g柠檬酸钠溶解于500ml水中，加入柠檬酸溶液（1/5）调节ph值至（5.0+-0.1），并加水稀释至10

9、00ml.Mobile phase-Dissolve 3.2g of tetraheptylammonium bromide(四庚基溴化氢) in 400ml of acetonitrile（乙腈）, add 44ml of pH 7.0 buffer and 4ml of pH 5.0 buffer ,and add water to make 1000ml, Filter （过滤）through a membrane filter（膜滤器） of 0.5um or finer porosity（细孔隙度）, and degas（脱气）.Make adjustment if necessar

10、y (see system suitability under chromatography<621>)流动相-取3.2g 四庚基溴化氢溶于400ml乙腈，并加入44ml pH为7.0 缓冲液和4ml pH为5.0的缓冲液，加水稀释至1000ml.用0.5um的滤膜或跟细小的滤膜过滤，脱气。如果有需要应适当做调整。（参阅色谱法项下的系统适用性。）Standard preparation-Dissolve an accurately weighed quantity of USP ceftriaxone sodium RS in mobile phase, to obtain a s

11、olution having a known concentration（浓度） of about 0.2mg per ml . Use this solution promptly（立即的、迅速的） after preparation .标准溶液的配制-精密称定适量的USP头孢曲松钠标准品溶于移动相中。制成已知浓度为每ml为0.2mg的溶液。配置后立即使用。Resolution(分离度) solution(分离度测试溶液)-Dissolve a suitable quantity of USP Ceftriaxone sodium e-isomer RS in standard soluti

12、on , and dilute with mobile phase to obtain a solution containing about 160ug of USP Ceftriaxone sodium e-isomer RS per ml and 160ug of USP ceftriaxone sodium RS per ml .Use this solution promptly after preparation .分离度测试溶液-取适量的USP头孢曲松钠反式同分异构体的标准品，溶解于标准溶液中。加入流动相稀释至每ml溶液含USP头孢曲松钠反式同分异构体标准品160ug及每ml含U

13、SP头孢曲松钠标准品160ug的溶液。配置后应立即使用。Assay preparation -Tranfer about 40mg of Ceftriaxone sodium ,accurately weighed,to a 200ml volumetric flask（容量瓶）,dissolve in and dilute with mobile phase to volume,and mix.Use this solution promptly after preparation .供试品溶液配制-取头孢曲松钠约40mg，精密称定，至200ml容量瓶中。加入流动相溶解并稀释至刻度，混匀。配

14、置后因立即使用。Chromatographic system （see chromatography <621>）-The liquid chromatography(液相色谱仪) is equiped with a 270-nm detector（检测器） and a 4.0-mm*15-mm column（圆柱） that contains 5-um packing（填充物） L1.The flow rate（流速） is about 2ml per minute. Chromatograph the resolution solution（向色谱仪中注射分离度测试溶液） ,a

15、nd record the peak responses as directed under procedure:the resolution,R, between the ceftriaxone e-isomer and ceftriaxone peaks is not less than 3.chromatograph the standard preparation ,and record the peak responses as directed under procedure:the column efficiency（柱效应） determined from the analyt

16、e peak（分析峰） is not less than 1500 theoretical plates（理论板数） ;the tailing factor（拖尾因子） for the analyte peak is not more than 2;and the relative standard deviation（相对标准偏差） for replicate injections（重复进样） is not more than 2%.色谱系统（参阅色谱法）-液相色谱的组成：检测器波长：270-nm，色谱柱：5um填料L1，规格：4.0-mm*15mm.流速为2ml/min,量取分离溶液，注入

17、液相色谱中，按照程序项下记录记录峰响应：头孢曲松钠反式同分异构体和头孢曲松钠的分离度应不小于3，量取适量标准液，注入色谱柱，按照程序项下记录峰响应：据分析峰而得的柱效应不低于1500理论板数，分析峰的拖尾因子应不大于2；重复进样的相对标准偏差不大于2%。Procedure-Separately inject equal volumes (about 20ul) of the standard solution and the assay preparation into the chromatograph, record the chromatograms, and measure the r

18、espones for the major peaks. Calculate the quantity, in ug, of ceftriaxone (c18h18n8o7s3)per mg of the ceftriaxone sodium taken by the formula: 200(CP/M)(ru/rs)In which C is the concentration(浓度) , in mg per ml, of USP ceftriaxone sodium RS in the standard preparation ; P is the desigenated potency（标示含量，效价）, in ug of ceftriaxone per mg,of USP ceftriaxone sodium RS ; W is the quantity, in mg , of the ceftriaxone sodium taken to prepare the assay preparation ; and ru and rs are the ceftriaxone peak responses obtained from the a