炽灼残渣3部药典翻译(全)

欧洲药典EP7.0-2.4.14 灼烧残渣

在600±50℃下炽灼一个合适材质的坩埚（例如，二氧化硅，铂金，石英，或者瓷质）30分钟，在盛有硅胶或其他合适干燥剂的干燥器中冷却，精确称量它的质量。称取订明质量的样品，放在之前冷却后的坩埚中。用少量（通常 1 mL）硫酸润湿样品，然后在尽量低的温度下慢慢加热，直至样品完全烧焦。冷却；然后又用少量（通常1 mL）硫酸润湿；缓慢加热至不再有白烟生成；再在600±50℃下炽灼，直至样品完全碳化。确保在整个程序中没有火焰生成。在盛有硅胶或其他合适干燥剂的干燥器中冷却，再次称重，然后计算残渣所占百分比。如果算得的数值明显超过订明限定，则需重复以上硫酸润湿、加热、炽灼的过程，炽灼30分钟，直至有连续两次测得的残渣的质量相差小于0.5 mg，或者算得的残渣百分比在订明限度内。

为了保证在订明的限度内，残渣的总质量有足够的精度（通常约1 mg），用于检测的样品也需适量（通常约1～2 g）。

英国药典BP2010-2.4.14

方法Ⅰ

（非欧洲药典法）

加热一个铂金碟至发红且保持10分钟，然后在干燥器中冷却、称重。除非文献特别要求，称取1 g样品在碟子上，用硫酸润湿后缓慢炽灼，再用硫酸润湿，在800℃下炽灼15分钟。干燥器中冷去、称重。重复以上程序，直至连续两次的残渣质量相差小于0.5 mg。

方法Ⅱ

（欧洲药典法2.4.14）

在600±50℃下炽灼一个合适材质的坩埚（例如，二氧化硅，铂金，石英，或者瓷质）30分钟，在盛有硅胶或其他合适干燥剂的干燥器中冷却，精确称量它的质量。称取订明质量的样品，放在之前冷却后的坩埚中。用少量（通常 1 mL）硫酸润湿样品，然后在尽量低的温度下慢慢加热，直至样品完全烧焦。冷却；然后又用少量（通常1 mL）硫酸润湿；缓慢加热至不再有白烟生成；再在600±50℃下炽灼，直至样品完全碳化。确保在整个程序中没有火焰生成。在盛有硅胶或其他合适干燥剂的干燥器中冷却，再次称重，然后计算残渣所占百分比。

如果算得的数值明显超过订明限定，则需重复以上硫酸润湿、加热、炽灼的过程，炽灼30分钟，直至有连续两次测得的残渣的质量相差小于0.5 mg，或者算得的残渣百分比在订明限度内。

为了保证在订明的限度内，残渣的总质量有足够的精度（通常约1 mg），用于检测的样品也需适量（通常约1～2 g）。

美国药典USP34-<281> 灼烧残渣

这个章节的部分与欧洲药典和日本药典的相应内容统一。而与其没有统一的部分则用（☆☆）标识出来。因此，药典中统一部分的内容是通用的，欧洲药典和（或）日本药典中关于灼炽残渣的检测方法可以代替现行的美国药典对应章节中的方法。这几部药典对这个统一章节不会做出任何单方面的改动。

所谓炽灼残渣（或硫酸盐灰分）的检测，就是测出样品经硫酸碳化再炽灼，没有从其中挥发出的剩余部分的总量。这种方法通常用来检测有机物质中无机杂质的含量。

步骤：在600±50℃下炽灼一个合适材质的坩埚（例如，二氧化硅，铂金，石英，或者瓷质）30分钟，在干燥器（硅胶或其他合适干燥剂）中冷却，精确称量它的质量。精确称取☆1～2 g或☆个别文献特定说明质量的样品，放在之前冷却后的坩埚中。用少量（通常 1 mL）硫酸润湿样品，然后在尽量低的温度下慢慢加热，直至样品完全烧焦。冷却；然后☆除非个别文献另有说明☆又用少量（通常1 mL）硫酸润湿；缓慢加热至不再有白烟生成；再在600±50℃下炽灼，☆除非个别文献另有说明☆直至样品完全碳化。确保在整个程序中没有火焰生成。在干燥器（硅胶或其他合适干燥剂）中冷却，精确称重，然后计算残渣所占百分比。

如果算得的数值明显超过特定文献的限定，则需重复以上硫酸润湿、加热、炽灼的过程，炽灼30分钟，直至有连续两次测得的残渣的质量相差小于0.5 mg，或者算得的残渣百分比在特定文献的限度内。

☆在通风良好的环境下进行炽灼，但是要防止气流，并且在低的温度下尽量保证碳的完全燃烧。如果需要，可以用马弗炉，这样可以确保最后炽灼的温度在600±50℃。马弗炉的校准，可以通过使用适合的电子温度仪和一个工作的热电偶探头来校对来自国家标准和技术机构的标准热电偶。确保称量的精确度，通过检查马弗炉设定温度与控制温度来确保控制电路。选择能够反应测试下样品可能使用方法的位置。每个测量位置的误差是±25℃。☆

吐温80英国药典英文

enan111，密码198834 2、消癌平注射液中吐温-80用量的研究及质量控制 2.1建立消癌平注射液中吐温-80含量的测定方法 2.2建立吐温-80纯度的测定方法 2.3不同厂家不同纯度的吐温-80增容效果及安全性评价 1、消癌平注射液中高分子杂质去除方法研究 1.1建立GPC法测定消癌平注射液中高分子物质的方法 1.2超滤前后高分子物质的去除效果研究 Polysorbate 80 Polyoxyethylene 20 Sorbitan Mono-oleate (Ph Eur monograph 0428) 9005-65-6 Ph Eur DEFINITION Polysorbate 80 is a mixture of partial esters of various fatty acids, mainly oleic acid, and sorbitol and its anhydrides copolymerised with approximately 20 moles of ethylene oxide for each mole of sorbitol and sorbitol anhydrides. The fatty acid fraction can be of vegetable or animal origin. It contains not less than 60.0 per cent of oleic acid and not less than 90.0 per cent and not more than 110.0 per cent of the content stated on the label. PRODUCTION 2-Chloroethanol, ethylene glycol and diethylene glycol Not more than 10 ppm of 2-chloroethanol and not more than a total of 0.25 per cent for ethylene glycol and diethylene glycol, determined by head-space gas chromatography (2.2.28), using themethod of standard additions.

British Pharmacopoeia 2013 Levonorgestrel左炔诺孕酮英国药典2013

Levonorgestrel General Notices (Ph. Eur. monograph 0926) C21H28O2 312.5 797-63-7 Action and use Progestogen. Preparations Levonorgestrel Tablets Levonorgestrel and Ethinylestradiol Tablets Ph Eur DEFINITION 13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one. Content 98.0 per cent to 102.0 per cent (dried substance). CHARACTERS Appearance White or almost white, crystalline powder. Solubility Practically insoluble in water, sparingly soluble in methylene chloride, slightly soluble in ethanol (96 per cent). IDENTIFICATION A. Specific optical rotation (see Tests). B. Infrared absorption spectrophotometry (2.2.24). Comparison levonorgestrel CRS. TESTS Specific optical rotation (2.2.7) -35 to -30.

英国药典2012 有关物质项译文

英国药典2012 有关物质项译文 液相色谱法（见2.2.29） 供试品溶液：取20mg本品用2mL乙腈溶解之后，用流动相A稀释至10.0mL。对照溶液(a)：去1.0mL待测溶液用流动相A稀释至100.0mL。再取该液1.0mL 用流动相A稀释至10.0mL。 对照溶液(b)：取布洛芬杂质B对照品1.0mL用乙腈稀释至10.0mL（溶液A）。取20mg布洛芬标准品用2mL乙腈溶解，加入1.0mL溶液A，并用流动相A稀释至10.0mL。 对照溶液(c)：用1mL乙腈溶解布洛芬（峰鉴别用）对照品，并用流动相A稀释至5mL。 色谱柱： 型号：l = 0.15 m, ? = 4.6 mm； 固定相：十八烷基键合硅胶，直径5μm； 流动相： 流动相A：将0.5体积的磷酸和340体积的乙腈、600体积的水混合，平衡后用水稀释至1000体积。 流动相B：乙腈 时间（min） 流动相A （体积百分比） 流动相B （体积百分比） 0-25 100 0 25-55 100→15 0→85

相对保留时间：布洛芬保留时间约为21min，杂质J约为0.2min，杂质N约为0.3，杂质A约为0.9，杂质B约为1.1。 系统适应性：对照溶液（b） 峰谷比：最小值1.5；Hp为杂质B的色谱峰顶点至基线的高度，Hv为布洛芬色谱峰和杂质B色谱峰分离的最低点至基线的高度。根据需要调整流动相A中乙腈的浓度。 限度： 杂质A、J、N：每种杂质均不超过对照溶液（a）色谱图中主成分峰面积的1.5倍（0.15%）； 非特定杂质：每种杂质均不超过对照溶液（a）色谱图中主成分峰面积的0.5倍（0.05%）； 总杂：不超过对照溶液（a）色谱图中主成分峰面积的2倍（0.2%）； 忽略限度：对照溶液（a）色谱图中主成分峰面积的0.3倍（0.03%）。 杂质F 气相色谱法（2.2.28）- 使用常规步骤 甲基化溶液：取1mLDMF-DMA和1mL吡啶，用乙酸乙酯稀释至10mL。 供试品溶液：取本品50.0mg于密封小瓶中，用1.0mL乙酸乙酯溶解，加入1mL甲基化溶液，密封，置于烘箱100°C高温加热20min。冷却后，室温氮气吹干，用5mL乙酸乙酯溶解残留物。 对照溶液（a）：用乙酸乙酯溶解0.5mg布洛芬杂质F，稀释至10.0mL。 对照溶液（b）：取50.0mg布洛芬标准品于密封小瓶中，用1.0mL对照溶液（a）溶解，加入1mL甲基化溶液，密封，置于烘箱100°C高温加热20min。冷却后，室温氮气吹干，用5mL乙酸乙酯溶解残留物。 色谱柱： 填料：石英玻璃

英国药典Appendix XVI C翻译

第一部分 Appendix XVI C. Efficacy of Antimicrobial Preservation (Ph. Eur. general text 5.1.3) 如果药物制剂本身没有足够的抗菌活性，那么就应该加抗菌防腐剂。在药品正常的储存和使用过程中，液体制剂特别是多剂量液体制剂，尤其需要添加防腐剂。这样不仅可以阻止细菌繁殖、限制微生物污染；还可以防止细菌污染给患者身体带来的危害和对药品本身的污染。抗菌防腐剂在GMP中不能被替代。 抗菌防腐剂的效果根据药物制剂的组成成分的不同、防腐剂加入的形式的不同、或使用容器或封口的不同而增强或减弱。在最终的包装容器内的制剂，我们需要验证它在整个有效期内的抗菌活性。这样才能保证在贮存过程中抗菌活性不会减弱。样品从最终容器中取出时就需要立即进行验证了。 在药物制剂发展期间（注：研发Research & Development，D就是发展期间，将活性分子变成处方制剂的过程），应该需要证明药物制剂本身的抗菌活性。如果没有就需要添加合适的防腐剂、或防腐剂能够保护制剂免于遭受微生物污染的不良效果和在贮存和使用过程中细菌的繁殖。 抗菌活性应该通过以下一系列测试来证实。这些测试并不用于常规的对照目的。 测试抗菌防腐剂的有效性 测试包括三方面内容：一、不论最后的包装容器是什么，都需要用规定的接种物，也就是合适的微生物对制剂进行攻击。二、在规定的温度下贮存已接种制剂。三、在一段时间间隔内抑制容器内的样本生长，然后计数这样被除去的样本中的菌数。 在测试条件下，如果在规定时间和温度下，接种后制剂中的菌落数有重大的下降或没有增加，那么药物制剂中防腐剂的作用就是可以接受的。接受标准（即在规定时间内减少微生物的数量）随着制剂类型的不同而不同。因为制剂类型的不同所达到的保护的程度也不同。（见表5.1.3-1/2/3）。 微生物检测（见附录二） 绿脓假单胞杆菌A TCC 9027; NCIMB 8626; CIP 82.118. 金黄色酿脓葡萄球菌ATCC 6538; NCTC 10788; NCIMB 9518; CIP 4.83. 白色念珠菌A TCC 10231; NCPF 3179; IP 48.72. 黑曲霉A TCC 16404; IMI 149007; IP 1431.83. 使用单菌株攻击而且设计微生物可以在合适的地方补充其他菌株或品种，这样就能代表可能的制剂污染。推荐大肠杆菌(A TCC 8739; NCIMB 8545; CIP 53.126)用于所有的口服制剂，鲁氏接合酵母(NCYC 381; IP 2021.92)用于所有的含有高浓度糖的口服制剂。 接种菌的准备 检测的开始阶段，在琼脂培养基B(2.6.12)表面接种细菌或在没有额外抗生素添加(2.6.12)

Sodium-Valproate-5571[英国药典BP2009]

Sodium Valproate General Notices (Ph Eur monograph 0678)

IDENTIFICATION A. Infrared absorption spectrophotometry (2.2.24). Comparison sodium valproate CRS. If the spectra obtained in the solid state show differences, record new spectra using discs prepared by placing 50 μl of a 100 g/l solution in methanol R on a disc of potassium bromide R and evaporating the solvent in vacuo. Examine immediately. B. Examine the chromatograms obtained in the test for related substances. Results The principal peak in the chromatogram obtained with test solution (b) is similar in retention time to the principal peak in the chromatogram obtained with reference solution (b). C. 2 ml of solution S (see Tests) gives reaction (a) of sodium (2.3.1) . TESTS Solution S Dissolve 1.25 g in 20 ml of distilled water R in a separating funnel, add 5 ml of dilute nitric acid R and shake. Allow the mixture to stand for 12 h. Use the lower layer. Appearance of solution The solution is not more opalescent than reference suspension II (2.2.1) and not more intensely coloured than reference solution Y6(2.2.2, Method II). Dissolve 2.0 g in water R and dilute to 10 ml with the same solvent. Acidity or alkalinity Dissolve 1.0 g in 10 ml of water R. Add 0.1 ml of phenolphthalein solution R . Not more than 0.75 ml of 0.1 M hydrochloric acid or 0.1 M sodium hydroxide is required to change the colour of the indicator. Related substances Gas chromatography (2.2.28). Internal standard solution Dissolve 10 mg of butyric acid R in heptane R and dilute to 200 ml with the same solvent. Test solution (a) Dissolve 0.500 g of the substance to be examined in 10 ml of water R . Add 5 ml of dilute sulphuric acid R and shake with 3 quantities, each of 20 ml, of heptane R. Add 10.0 ml of the internal standard solution to the combined upper layers, shake with anhydrous sodium sulphate R , filter and evaporate the filtrate, at a temperature not exceeding 30 °C, using a rotary evaporator. Take up the residue with heptane R and dilute to 10.0 ml with the same solvent. Dilute 1.0 ml of this solution to 10.0 ml with heptane R . Test solution (b) Dissolve 40 mg of the substance to be examined in 100 ml of water R . To 10 ml of this solution add 0.5 ml of dilute sulphuric acid R and shake with 3 quantities, each of 5 ml, of heptane R . Shake with anhydrous sodium sulphate R, filter and evaporate the filtrate, at a temperature not exceeding 30 °C, to a volume of about 10 ml, using a rotary

国外药典

药典（pharmacopoeia）是一个国家记载药品标准、规格的法典，一般由国家药品监督管理局主持编纂、颁布实施，国际性药典则由公认的国际组织或有关国家协商编订。制定药品标准对加强药品质量的监督管理、保证质量、保障用药安全有效、维护人民健康起着十分重要的作用。药品标准是药品现代化生产和质量管理的重要组成部分，是药品生产、供应、使用和监督管理部门共同遵循的法定依据。药品质量的内涵包括三方面：真伪、纯度、品质优良度。三者的集中表现是使用中的有效性和安全性。因此，药品标准一般包括以下内容：法定名称、来源、性状、鉴别、纯度检查、含量（效价或活性）测定、类别、剂量、规格、贮藏、制剂等等。 药典是从本草学、药物学以及处方集的编著演化而来。药典的重要特点是它的法定性和体例的规范化。中国最早的药物典籍，比较公认的是公元 659年唐代李淳风、苏敬等22人奉命编纂的《新修本草》。全书54卷，收载药物844种，堪称世界上最早的一部法定药典。15世纪印刷术的进步促进了欧洲近代药典编纂的发展。许多国家都相继制订各自的药典。1498年由佛罗伦萨学院出版的《佛罗伦萨处方集》，一般视为欧洲第一部法定药典。其后有不少城市纷纷编订具有法律约束性的药典。其中纽伦堡的瓦莱利乌斯医生编著的《药方书》赢得了很高的声誉，被纽伦堡当局承认，被定为第一本《纽伦堡药典》于1546年出版。在《纽伦堡药典》的影响下，在奥格斯堡、安特卫普、里昂、巴塞尔、巴伦西亚、科隆、巴黎和阿姆斯特丹等地也相继有药典问世。这一进展标志着欧洲各地区性药典向法定性国家药典转化的新阶段。 到20世纪90年代初，世界上至少已有38个国家编订了国家药典。另外，尚有区域性药典3种及世界卫生组织(WHO)编订的《国际药典》。下面简介几部著名药典。 英国药典(BP) 《英国药典》（British Pharmacopoeia，简称BP）是由英国药典委员会（British Pharmacopoeia Commission）编制，是英国制药标准的重要来源。英国药典不仅为读者提供了药用和成药配方标准以及公式配药标准，而且也向读者展示了许多明确分类并可参照的欧洲药典专著。

头孢拉定胶囊英国药典BP2013 UpdatedB

?British Pharmacopoeia Volume III ?Formulated Preparations: Specific Monographs Cefradine Capsules General Notices Action and use Cephalosporin antibacterial. DEFINITION Cefradine Capsules contain Cefradine. The capsules comply with the requirements stated under Capsules and with the following requirements. Content of cephalosporins, calculated as the sum of cefradine (C16H19N3O4S), cefalexin (C16H17N3O4S) and 4′,5′-dihydrocefradine (C16H21N3O4S) 90.0 to 105.0% of the stated amount of Cefradine. IDENTIFICATION CHROMATOGRAPHIC CONDITIONS (a) Use a TLC silica gel plate (Analtech plates are suitable). Impregnate the plate by placing it in a tank containing a shallow layer of a 5% v/v solution of n-tetradecane in n-hexane, allowing the impregnating solvent to ascend to the top, removing the plate from the tank and allowing the solvent to evaporate; use with the flow of the mobile phase in the same direction that the impregnation was carried out. (b) Use the mobile phase as described below. (c) Apply 5 μL of each solution. (d) Develop the plate to 15 cm. (e) After removal of the plate, heat at 90° for 2 to 3 minutes and spray the hot plate with a 0.1% w/v solution of ninhydrin in the mobile phase. Heat at 90° for 15 minutes in a circulating air oven with the plates parallel to the airflow, cool for 15 minutes protected from light and examine in daylight.

BP2015英国药典索引

page numbers in bold type relate to monograph titles Index V-A797 Index Page numbers in bold type relate to monograph titles. Pages–Vol I:i–xxxii,(Preliminaries and Introduction) 1–1280,(General Notices and Monographs) Pages–Vol II:i–viii,(Preliminaries) 1–1220,(General Notices and Monographs) Pages–Vol III:i–viii,(Preliminaries) 1–1238,(General Notices and Monographs) Pages–Vol IV:i–viii,(Preliminaries) 1–754,(General Notices and Monographs) Pages–Vol V:i–viii,(Preliminaries) 1–34,(General Notices) S1–S144,(Spectra) A1–A796,(Appendices;Supplementary Chapters)

A Abacavir,V-S4 Abacavir Oral Solution,III-85 Abacavir Sulfate,I-39 Abacavir Tablets,III-86 Abbreviated,V-598 Adjectives,V-598 Anions,V-598 Cations,V-598 Preparations,V-598 Titles of Monographs,V-598 Abbreviated Titles,Status of,I-7,II-7, III-7,IV-7,V-7 Abbreviations and symbols,I-30,II-30, III-30,IV-30,V-30 Abnormal Toxicity,Test for,V-409 About,de?nition of,I-5,II-5,III-5, IV-5,V-5 Absence of Mycoplasmas,Test for V-487 Absolute Ethanol,V-A61 Absolute Ethanol R1,V-A62 Absorbent Cotton,IV-743 Absorbent Viscose Wadding,IV-744 Absorption spectrophotometry,infrared, V-162 Absorption Spectrophotometry, Ultraviolet and Visible,V-169 Acacia,I-41,V-A19 Acacia Solution,V-A19 Acacia Spray-dried,I-42 Acamprosate Calcium,I-43 Acanthopanax Bark,IV-49 Acarbose,I-44 Accuracy,V-674 Acebutolol Capsules,III-87 Acebutolol Hydrochloride,I-46,V-S5, V-A19 Acebutolol Tablets,III-88 Aceclofenac,I-48 Acemetacin,I-50 Acenocoumarol,I-52,V-S5 Acenocoumarol Tablets,III-88 Acesulfame Potassium,I-52 Acetal,V-A19 Acetaldehyde,V-A19 Acetaldehyde Ammonia Trimer Trihydrate,V-A20 Acetaldehyde Standard Solution (100ppm C2H4O),V-A148 Acetaldehyde Standard Solution (100ppm C2H4O)R1,V-A148 Acetamide,V-A20 Acetate Buffer pH2.8,V-A152 Acetate Buffer pH2.45,V-A152 Acetate Buffer pH3.4,V-A152 Acetate Buffer pH3.5,V-A152 Acetate Buffer pH3.7,V-A152 Acetate Buffer pH4.4,V-A152 Acetate Buffer pH4.6,V-A152 Acetate Buffer pH5.0,V-A152 Acetate Buffer pH6.0,V-A152 Acetate Buffer Solution pH4.7R1, V-A153 Acetate Buffer Solution pH4.4,see Acetate Buffer pH4.4 Acetate Buffer Solution pH4.6,see Acetate Buffer pH4.6Acetate Buffer Solution pH6.0,see Acetate Buffer pH6.0 Acetate Buffer Solution pH4.4,V-A152 Acetate Buffer Solution pH4.5,V-A152 Acetate Buffer Solution pH4.7,V-A152 Acetate Buffer Solution pH5.0,V-A153 Acetate Buffer Solution pH6.0,V-A153 Acetate–edetate Buffer Solution pH5.5, V-A153 Acetates,Reactions of,V-266 Acetazolamide,I-54,V-S5 Acetazolamide Oral Suspension,III-89 Acetazolamide Tablets,III-90 Acetic Acid,V-A20 Acetic Acid(6per cent),I-56 Acetic Acid(33per cent),I-56 Acetic Acid,Anhydrous,V-A20 Acetic Acid,Deuterated,V-A50 Acetic Acid,Dilute,V-A20 Acetic Acid,Dilute,see Acetic Acid (6per cent) Acetic Acid,Glacial,I-55,V-A20 Acetic Acid in Synthetic Peptides, Determination of,V-299 Acetic Acid VS,V-A142 Acetic Acid,see Acetic Acid(33per cent) Acetic Anhydride,V-A20 Acetic Anhydride Solution R1,V-A20 Acetic Anhydride–Dioxan Solution, V-A20 Acetic Anhydride–Sulfuric Acid Solution, V-A20 Acetic Anhydride–Sulphuric Acid Solution,see Acetic Anhydride–Sulfuric Acid Solution Acetic Bromine Solution,V-A34 Acetone,I-57,V-A20 Acetone,Deuterated,V-A50 Acetone Solution,Buffered,V-A153 Acetone-dried Ox Brain,V-A98 Acetonitrile,V-A20 Acetonitrile for Chromatography,V-A20 Acetonitrile R1,V-A20 Acetoxyvalerenic Acid,V-A20 Acetyl Chloride,V-A20 Acetyl Groups,Reactions of,V-266 Acetyl Salicylic Acid see Aspirin Acetyl Value,Determination of,V-317 Acetylacetamide,V-A20 Acetylacetone,V-A20 Acetylacetone Reagent R1,V-A20 Acetylacetone Reagent R2,V-A20 4-Acetylbiphenyl,V-A20 O-Acetyl Groups in Polysaccharide Vaccines,V-467 N-Acetyl-e-caprolactam,V-A20 Acetylcholine Chloride,I-58,V-A20 Acetylcysteine,I-59,V-S6 Acetylcysteine Eye Drops,III-90 Acetylcysteine Injection,III-91 Acetyldigoxin,I-61 b-Acetyldigoxin see Acetyldigoxin Acetyleugenol,V-A20 N-Acetylglucosamine,V-A21 Acetyl-11-keto-b-boswellic Acid,V-A21 N-Acetyl-L-cysteine,V-A20 N-Acetylneuraminic Acid,V-A21 Acetylsalicylic Acid Tablets,see Aspirin Tablets N-Acetyltryptophan,V-A21 N-Acetyltryptophan see Acetyltryptophan Acetyltryptophan,I-63 Acetyltyrosine,I-65 N-Acetyltyrosine see Acetyltyrosine Acetyltyrosine Ethyl Ester,V-A21 Acetyltyrosine Ethyl Ester,0.2M,V-A21 Aciclovir,I-67 Aciclovir Cream,III-93 Aciclovir Eye Ointment,III-94 Aciclovir Infusion,III-95 Aciclovir Intravenous Infusion,see Aciclovir Infusion, Aciclovir Oral Suspension,III-97 Aciclovir Sodium for Infusion,III-95 Aciclovir Sodium for Intravenous Infusion,see Aciclovir Sodium for Infusion, Aciclovir Tablets,III-98 Aciclovir Tablets,Dispersible,III-99 Acid Blue92,V-A21 Acid Blue92Solution,V-A21 Acid Blue83,V-A21 Acid Blue93Solution,V-A21 Acid Blue90,V-A21 Acid Gentian Mixture,IV-197 Acid Gentian Oral Solution,IV-197 Acid Potassium Iodobismuthate Solution,V-A108 Acid Value,V-317 Acid/base Indicators,V-789 Acid-base titrations,V-788 Acidi?ed Chloroform,V-A41 Acidi?ed Dichloromethane,V-A52 Acidi?ed Methanol,V-A85 Acidi?ed Methylene Chloride,see Acidi?ed Dichloromethane Acid-insoluble Ash,Determination of, V-336 Acid-washed Diatomaceous Support, V-A51 Acitretin,I-69 Acitretin Capsules,III-100 Acknowledgements,I-xxvii Acrylamide,V-A21 Acrylamide/bisacrylamide(29:1) Solution,30per cent,V-A21 Acrylamide/bisacrylamide(36.5:1) Solution,30per cent,V-A21 Acrylic Acid,V-A21 Actein,V-A21 Acteoside,V-A21 Action and Use Statement,Status of, I-17,II-17,III-17,IV-17,V-17 Activated Acid Aluminium Oxide,V-A23 Activated Attapulgite,I-220 Activated Charcoal,I-496,V-A40 Activated Zinc,V-A140 Active Moiety,V-651 Adamantane,V-A21 Adapalene,I-71 Adapalene Cream,III-101 Adapalene Gel,III-103 Additions,List of,I-xxviii Additions,List of Monographs,I-xxii Additives,Plastic,V-592 Adenine,I-72,V-A21 Adenosine,I-73,V-A21 Adipic Acid,I-75,V-A21 Adrenaline,V-A21 Adrenaline/Epinephrine,I-76 page numbers in bold type relate to monograph titles Index V-A799

Nicorandil BP2016.mht 尼卡地尔英国药典2016版

?Publications ?Monographs: Medicinal and Pharmaceutical Substances ?Nicorandil ?Table of Contents ?Content Print Search within this version 提交查询内容 Type a keyword or a title Advanced Search Status:Version effective from 01/04/2016. Updated Ph. Eur. 8.6, effective 01/01/2016 Maximise Nicorandil General Notices (Ph. Eur. monograph 2332) C8H9N3O4211.265141-46-0 Action and use Potassium channel opener. Preparation Nicorandil Tablets Ph Eur DEFINITION 2-[(Pyridin-3-ylcarbonyl)amino]ethyl nitrate. Content 99.0 per cent to 101.0 per cent (anhydrous substance). CHARACTERS Appearance White or almost white, crystalline powder. Solubility Sparingly soluble in water, freely soluble in anhydrous ethanol, practically insoluble in heptane. IDENTIFICATION Infrared absorption spectrophotometry(2.2.24). Comparison nicorandil CRS.

药材英国药典标准1(中文)

白芍饮片 通则 [定义] 传统草药制剂中使用的白芍饮片是经过酒炙、去皮和干燥的白芍药材。按干燥品计算，含芍药苷不得少于1.6%。 [制作] 夏秋二季采挖，洗净，除去头尾和细根，置沸水中煮后除去外皮或去皮后再煮，晒干。干燥的根部先充分润洗，然后横切或纵切成薄片，干燥即得。 [鉴别] A 根的切片呈灰白色或淡棕色，边缘颜色较深，大约2mm厚。表面光洁或有短的纵皱纹及细根痕。横切片呈直径约4.5cm椭圆形状，切面有明显的放射状脉管组织。纵切片大约10cm长，1.5cm宽，切面纵向有明显的脉管组织。 B 微粉化，粉未呈黄白色。用水合氯醛溶液溶解后于显微镜下观测，粉未中有很多单个或成群存在的圆形的，矩形的或伸长状的薄壁组织细胞，有些还具有凹痕的或珠状的细胞壁。很多细胞中还含有黄白色或粉红色的糊化淀粉粒。草酸钙簇晶直径11～35微米，存在于薄壁细胞中，常排列成行或一个细胞中含数个簇晶。具缘纹孔导管和网纹导管直径20～65微米。纤维长梭形，直径15～40微米，壁厚，微木化，具大的圆形纹孔。 C 在含量测定项下记录的色谱图中，溶液（1）有一个峰的保留时间与溶液（2）的主峰保留时间一致。 D 照薄层色谱法（附录ⅢA），配制下列溶液： （1）取本品粉未0.5g,加乙醇10mL，振摇5分钟，滤过，滤液蒸干，残渣加乙醇1 mL使溶解 （2）取芍药苷和4-对羟基苯乙酮对照品用乙醇溶解，制成0.1% （w/v）的溶液色谱条件： （a）硅胶G板（默克硅胶G60预制板适用） （b）展开剂：甲酸-乙酸乙酯-甲醇-二氯甲烷（0.2:5:10:40） （c）点样量：10μL，条带状点样 （d）展距15cm （e）晾干,喷以5%香草醛硫酸溶液,105℃中加热5分钟,使斑点显色清晰，立即检 测 系统适应性：在溶液（2）的色谱图中，应显示两个相互分离的斑点。 判断：在Rf值大约0.4处，溶液（1）的色谱与溶液（2）相应的位置上，显相同颜 色的蓝紫色斑点，溶液（1）的色谱应呈现以下斑点： [检查]

2014年英国药典

Appendix XVI B. Microbiological Examination of Non-sterile Products 1. Test for Specified Micro-organisms1 (Ph. Eur. method 2.6.13) 1 INTRODUCTION The tests described hereafter will allow determination of the absence or limited occurrence of specified micro-organisms that may be detected under the conditions described. The tests are designed primarily to determine whether a substance or preparation complies with an established specification for microbiological quality. When used for such purposes, follow the instructions given below, including the number of samples to be taken, and interpret the results as stated below. Alternative microbiological procedures, including automated methods, may be used, provided that their equivalence to the Pharmacopoeia method has been demonstrated. 2 GENERAL PROCEDURES The preparation of samples is carried out as described in general chapter 2.6.12. If the product to be examined has antimicrobial activity, this is insofar as possible removed or neutralised as described in general chapter 2.6.12. If surface-active substances are used for sample preparation, their absence of toxicity for micro-organisms and their compatibility with inactivators used must be demonstrated as described in general chapter 2.6.12. 3 GROWTH-PROMOTING AND INHIBITORY PROPERTIES OF THE MEDIA, SUITABILITY OF THE TEST AND NEGATIVE CONTROLS The ability of the test to detect micro-organisms in the presence of the product to be tested must be established. Suitability must be confirmed if a change in testing performance, or the product, which may affect the outcome of the test is introduced. 3-1 Preparation of test strains Use standardised stable suspensions of test strains or prepare them as stated below. Seed lot culture maintenance techniques (seed-lot systems) are used so that the viable micro-organisms used for inoculation are not more than 5 passages removed from the original master seed-lot. 3-1-1 Aerobic micro-organisms Grow each of the bacterial test strains separately in casein soya bean digest broth or on casein soya bean digest agar at 30-35 °C for 18-24 h. Grow the test strain for Candida albicans separately on Sabouraud-dextrose agar or in Sabouraud-dextrose broth at 20-25 °C for 2-3 days. ?—Staphylococcus aureus such as ATCC 6538, NCIMB 9518, CIP 4.83 or NBRC 13276; ?—Pseudomonas aeruginosa such as ATCC 9027, NCIMB 8626, CIP 82.118 or NBRC 13275; ?—Escherichia coli such as ATCC 8739, NCIMB 8545, CIP 53.126 or NBRC 3972; ?—Salmonella enterica subsp. enterica serovar Typhimurium, such as ATCC 14028 or, as an alternative, Salmonella enterica subsp. enterica serovar Abony such as NBRC 100797, NCTC 6017 or CIP 80.39; ?—Candida albicans such as ATCC 10231, NCPF 3179, IP 48.72 or NBRC 1594.