Aspirin(USP 34)Aspirin contains not less than 99.5 percent and not more than 100.5 percent ofC9H8O4.calculated on the dried basis.根据干燥品计算，本品C9H8O4为标示量的99.5%~100.5%。
Packaging and storage -Preserve in the tight containers.包装与贮藏-贮藏于封闭的容器中。
USP REFERENCE STANDRANDS<11>-USP Aspirin RSUSP 标准物质-USP 阿司匹林对照品Identification-A: Heat it with water for minutes,cool,and add 1 or 2 drops ferric chloride TS: a violed-red color is produced.鉴别-1.水浴加热数分钟，冷却，加入1到2滴FeCl3 试液，测得颜色为紫红色。
B: Infrared AbsorptionLoss on Drying-Dry it over silica gel for 5 hours: it loses not more than 0.5% of its weight.干燥失重-硅胶干燥器中干燥5小时，减少重量不得超过0.5%。
Readily carbonizable substances-Dissolve 500mg in 5ml of sulfuric acid: the solution has no more color than matching fluid Q.易碳化物-取500mg本品溶于5ml硫酸溶液中，溶液颜色不得深于标准溶液Q。
Residue on Ignition: not more than 0.05%.炙灼残渣-不得超过0.05%。
<1058> ANALYTICAL INSTRUMENT QUALIFICATION 分析仪器的确认INTRODUCTION 介绍A large variety of laboratory equipment, instruments, and computerized analytical systems, ranging from simple nitrogen evaporators to complex multiple-function technologies (see Instrument Categories ), are used in the pharmaceutical industry to acquire data to help ensure that products are suitable for their intended use. An analyst 's objective is to consistently obtain reliable and valid data suitable for the intended purpose. Depending on the applications, users validate their procedures, calibrate their instruments, and perform additional instrument checks, such as system suitability tests and analysis of in-process quality control check samples to help ensure that the acquired data are reliable. With the increasing sophistication and automation of analytical instruments, an increasing demand has been placed on users to qualify their instruments.极其多种多样的实验室设备、仪器、计算机分析系统，从简单的氮吹仪到复杂的多功能技术（见仪器种类），被应用于制药工业，以取得数据来确保产品适合其预定用途。
<1225>V ALIDATION OF COMPENDIAL PROCEDURES药典规程的验证Test procedures for assessment of the quality levels of pharmaceutical articles are subject to various requirements. According to Section 501 of the Federal Food, Drug, and Cosmetic Act, assays and specifications in monographs of the United States Pharmacopeia and the National Formulary constitute legal standards. The Current Good Manufacturing Practice regulations [21 CFR 211.194(a)] require that test methods, which are used for assessing compliance of pharmaceutical articles with established specifications, must meet proper standards of accuracy and reliability. Also, according to these regulations [21 CFR 211.194(a)(2)], users of analytical methods described in USP-NF are not required to validate the accuracy and reliability of these methods, but merely verify their suitability under actual conditions of use. Recognizing the legal status of USP and NF standards, it is essential, therefore, that proposal for adoption of new or revised compendial analytical procedures be supported by sufficient laboratory data to document their validity.用于评价药物质量水平的测试规程受到多种要求的影响。
Ceftriaxone Sodium(USP32)Ceftriaxone sodium contains the equivalent of not less than 795ug of ceftriaxone permg,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 preparing 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 corresponds 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。
