盐酸二甲双胍质量标准(英国药典)
盐酸二甲双瓜片 进口注册标准
一、概述盐酸二甲双瓜片是一种常用的抗组胺药，被广泛应用于治疗过敏性疾病，如过敏性鼻炎、过敏性皮炎等。
在国际上，盐酸二甲双瓜片是一种处方药，需经过严格的进口注册标准审批程序，才能在国内市场上销售和使用。
本文将对盐酸二甲双瓜片进口注册标准进行详细介绍。
二、标准概况1. 盐酸二甲双瓜片的注册标准主要包括药品质量标准、药品生产标准、药品使用标准等内容。
其中，药品质量标准是指药品的理化特性、微生物指标、有害杂质等方面的要求；药品生产标准是指药品生产过程中的相关要求，包括原辅料的选择与控制、生产工艺的规范与控制、生产环境的规范等；药品使用标准是指药品的适应症、用法用量、不良反应、禁忌等方面的要求。
2. 盐酸二甲双瓜片的注册标准应符合国际上相关的规定，如国际药典委员会（ICH）的相关指南、美国食品药品管理局（FDA）的相关规定等。
应根据国内的相关法律法规和标准，进行具体的要求。
三、审批流程1. 盐酸二甲双瓜片的进口注册标准审批由国家药品监督管理部门进行。
申请人需要提供完整的注册申请资料，包括药品质量控制、生产工艺、药品使用等相关资料。
还需要提供原产地的GMP证书、生产企业生产许可证、药品生产批签发文件等相关证明材料，以证明产品的质量和生产工艺符合国家的相关要求。
2. 在提交注册申请资料后，国家药品监督管理部门将进行初步审查，并进行GMP认证和现场审核。
审核包括对生产企业的生产环境、设备设施、生产工艺流程、质量管理体系等方面的审核，以确保生产过程符合国家的相关法规和标准。
3. 审查通过后，国家药品监督管理部门将颁发批准文号，并发布相关公告。
此时，盐酸二甲双瓜片才能在国内市场上销售和使用。
生产企业需要按照批准文号的相关要求，对产品进行严格的质量控制和生产管理。
四、进口注册标准的重要性1. 盐酸二甲双瓜片是一种处方药，对患者的身体健康至关重要。
进口注册标准的严格执行，可以有效保障产品的质量和安全性，降低患者用药风险，保护患者的合法权益。
盐酸
一、项目名称中文名称：盐酸二甲双胍片英文名称：Metformin Hydrochloride Tablets商品名：无化学名：1，1—二甲基双胍盐酸盐分子式：C23H35NaO国内外上市情况：盐酸二甲双胍片目前在FDA、欧盟、日本均有上市。
目前国内盐酸二甲双胍片有批准文号119个，其中0.85g规格1个（原研地产化批准文号），0.5g规格7个（包括1个进口药品批准文号，1个原研地产化批准文号），0.25g规格111个；原料有14个国产批准文号；2个进口批准文号。
用法用量：口服。
成人开始一次0.25g，一日2~3次，以后根据疗效逐渐加量，一般每日量1~1.5g，最多每日不超过2g。
不良反应及用药注意事项：二甲双胍最常见的不良反应为胃肠道反应，其原因可能是二甲双胍在胃内快速溶解后高浓度附着在消化道粘膜上，从而产生刺激作用。
二甲双胍最严重的不良反应是乳酸酸中毒。
此不良反应虽然发生率很低（小于10万分之1），但死亡率很高。
为降低乳酸酸中毒的发生率，在血糖控制不理想，出现糖尿病酮症、长期禁食、重症感染、酗酒、肝功能不全及组织缺氧等情况下需避免使用二甲双胍。
同时非类固醇类抗炎药、利尿药会增加二甲双胍发生乳酸酸中毒的风险，尤其是近期联合使用H2-拮抗剂（如西咪替丁）的患者。
二、立项依据1. 国外同类产品与技术研究概况及发展趋势；自1957年上市以来，二甲双胍已经在治疗糖尿病的里程中走过了60年，其在临床上应用价值不断地被发掘。
1959年sterne等发现二甲双胍能减少控制血糖水平所需的胰岛素的用量。
1961年兰伯特（Rambarr）研究表明二甲双胍控制高血糖而不导致低血糖，安全有效。
1995年二甲双胍被美国FDA正式批准用于治疗2型糖尿病。
1998年UKPDS证明二甲双胍具有明确的心血管保护作用。
2004年，欧盟批准二甲双胍用于10岁以上儿童2型糖尿病的治疗。
2005年，Cochrane 协助组荟萃分析显示了二甲双胍近50年的临床疗效及安全性，同年，国际糖尿病联盟（IDF）指南颁布，进一步明确了二甲双胍是2型糖尿病药物治疗的基石。
盐酸胍标准问题回答
盐酸胍标准
盐酸胍标准
盐酸胍是一种重要的有机化学品，广泛应用于医药、染料、农药等领域。
为了保证盐酸胍的质量和安全性，各国都制定了相应的标准。
下面将介绍盐酸胍的标准及其重要性。
一、盐酸胍的标准
1.国际标准
国际上对盐酸胍的标准主要有以下两个：
（1）美国药典（USP）：规定了盐酸胍的质量标准、检测方法、包装和标签等内容。
（2）欧洲药典（EP）：对盐酸胍的质量标准、检测方法、包装和标签等方面进行了规定。
2.国内标准
我国对盐酸胍的标准主要有以下两个：
（1）国家药典：规定了盐酸胍的质量标准、检测方法、包装和标签等内容。
（2）行业标准：如GB/T 29496-2013《盐酸胍》等，对盐酸胍的质量标准、检测方法、包装和标签等方面进行了规定。
二、盐酸胍标准的重要性
1.保证产品质量
盐酸胍作为一种重要的有机化学品，其质量的好坏直接影响到最终产品的质量。
制定盐酸胍标准，可以保证产品的质量稳定，避免因质量问题导致的经济损失和声誉损失。
2.保障人体健康
盐酸胍作为一种医药原料，其质量的好坏直接关系到人体健康。
制定盐酸胍标准，可以保障人体健康，避免因质量问题导致的不良反应和健康风险。
3.促进行业发展
盐酸胍作为一种重要的有机化学品，其应用领域广泛。
制定盐酸胍标准，可以促进行业的发展，提高产品的竞争力，推动行业的健康发展。
三、结语
盐酸胍标准的制定对于保证产品质量、保障人体健康和促进行业发展
具有重要意义。
各国应加强标准的制定和执行，共同推动盐酸胍行业
的发展。
Medlife,1115-70-4,盐酸二甲双胍,技术规格说明书(SDS)
1115-70-4|盐酸二甲双胍，技术规格说明书(SDS)简介：盐酸二甲双胍，Metformin (hydrochloride)是FDA批准的用于治疗2型糖尿病的一线药物。
二甲双胍主要是通过对线粒体呼吸链复合物1的轻度和短暂抑制降低肝脏葡萄糖的产生。
盐酸二甲双胍物理化学性质：盐酸二甲双胍详细介绍：盐酸二甲双胍参考文献：[1]. Soraya H, et al. Acute treatment with metformin improves cardiac function following isoproterenol induced myocardial infarction in rats. Pharmacol Rep. 2012;64(6):1476-84.[2]. Quaile MP, et al. Toxicity and toxicokinetics of metformin in rats. Toxicol Appl Pharmacol. 2010 Mar 15;243(3):340-7.[3]. Xue J, et al. Metformin inhibits growth of eutopic stromal cells from adenomyotic endometrium via AMPK activation and subsequent inhibition of AKT phosphorylation: a possible role in the treatment of adenomyosis. Reproduction. 2013 Aug 21;146(4):397-406.[4]. Otto M, et al. Metformin inhibits glycogen synthesis and gluconeogenesis in cultured rat hepatocytes. Diabetes Obes Metab. 2003 May;5(3):189-94.[5]. Avci CB, et al. Therapeutic potential of an anti-diabetic drug, metformin: alteration of miRNA expression in prostate cancer cells. Asian Pac J Cancer Prev. 2013;14(2):765-8.[6]. Nie L, et al. The Landscape of Histone Modifications in a High-Fat Diet-Induced Obese (DIO) Mouse Model. Mol Cell Proteomics. 2017 Jul;16(7):1324-1334.[7]. Zhang D, et al. Metformin ameliorates BSCB disruption by inhibiting neutrophil infiltration and MMP-9 expression but not direct TJ proteins expression regulation. J Cell Mol Med. 2017 Jul 12.产品技术规格说明书由上海创赛科技有限公司收集整理，仅作参考使用。
盐酸二甲双胍缓释片质量标准
盐酸二甲双胍缓释片质量标准
一. 产品名称：
盐酸二甲双胍缓释片
二. 性状描述：
本品为斑点状或类似片状的白色、黄色或类似片状的物质。
三. 质量标准：
1. 外观：本品为斑点状或类似片状的物质，色白、黄色或类似片状，无杂质。
2. 硬度：≥60N。
3. 盐酸二甲双胍含量：90.0%-110.0%。
4. 溶解度：本品在0.1mol/L盐酸和水中均易溶。
5. 铅：≤5mg/kg。
6. 砷：≤3mg/kg。
7. 汞：≤1mg/kg。
8. 镉：≤1mg/kg。
9. 热失重：≤2.0%。
四. 适用范围：
本品适用于治疗2型糖尿病患者的糖代谢异常。
五. 用法用量：
口服。
成人初始每日剂量为500毫克或1克，每日1次，随餐服用。
剂量应在个体化治疗的基础上逐渐递增，不得超过每日2克。
六. 保存方法：
密闭、防潮、光线避免且存放于干燥处。
七. 批准文号：
国药准字H20080875
八. 生产企业：
广东珠江药业股份有限公司
九. 包装：
本品采用铝塑泡腔包装，每板14片，每箱8板。
盐酸二甲双胍质检方法
盐酸二甲双胍质检方法一：质量指标二：质量检验方法1、外观性状目测颜色、颗粒形状，本品应为白色结晶或结晶性粉末，用鼻测其气味，几乎无臭。
2、溶解性（澄清度）盐酸二甲双胍分别能溶于水合甲醇中，且水中的溶解度要远比甲醇中大。
精确称量1.000g盐酸二甲双胍，加10mL水于比色管中，待完全溶解后，比色管从上往下看，如果纯清则表示其在水中的澄清度合格；同样精确称量1.000g盐酸二甲双胍，加30mL甲醇于比色管中，边晃动边使其慢慢溶解，待完全溶解后，比色管从上往下看，如果纯清则表示其在甲醇中的澄清度合格。
3、干燥失重精确称重1.000克样品于一称量皿中，放于105℃干燥炉中4小时至恒重，取出后放于一干燥皿中至室温，称重计算，减重不超过0.5%为样品合格。
计算方法如下：干燥失重=（m样—m干）÷m样4、炽灼残渣600度坩埚，先在高温箱中600℃加热1小时，而后取出放入干燥皿中冷却，精确称重。
准确称重1.000g样品放于坩埚中，直接放电炉加热至没有青烟（约半小时左右）凉至室温加0.5mL 硫酸，继续放电炉加热至无烟(低温加热至硫酸蒸汽，全部除尽)，而后放于600度高温炉中2小时，取出放于干燥皿中完成冷却，精密称量后，再在600-800℃炽灼至恒重，称重计算，小于0.1%为合格。
计算：A最后残渣质量÷m样品质量5、有关杂质（双氰胺对照试验）取二甲样品0.5g，加无水甲醇5mL（沿壁加入）于试管1中，水浴加热至完全溶解（加热取出多次，防止沸出试管），而后自然降温至35度，再加5mL乙醚搅拌冷却至20度，静止30分钟，用滤纸过滤，再用2.5mL乙醚洗试管，同样过滤合并滤液。
滤液。
滤液置水浴上蒸发至干，（可先用电炉蒸干一部分水），残渣加水0.5mL溶解，作为备用样品。
双氰胺对照试样，取双氰胺对照品0.004g，溶于10mL水中，作为备用对照（即没1mL中含0.4mg）展开剂配比：正戊醇、吡啶、水（1:2:1.8），分别取样品5mL、10mL、9mL混合于瓶中备用。
盐酸二甲双胍Metformin Hydrochloride BP2010
盐酸二甲双胍Metformin Hydrochloride（BP2010）General Notices(Ph Eur monograph 0931)C 4H11N5,HCl 165.6 1115-70-4Action and useBiguanide; treatment of diabetes mellitus. PreparationMetformin TabletsPh EurDEFINITION1,1-Dimethylbiguanide hydrochloride.Content98.5 per cent to 101.0 per cent (dried substance).CHARACTERSAppearanceWhite or almost white crystals.SolubilityFreely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene chloride.IDENTIFICATIONFirst identification B, E.Second identification A, C, D, E.A. Melting point(2.2.14): 222 °C to 226 °C.B. Infrared absorption spectrophotometry(2.2.24).Preparation Discs of potassium chloride R.Comparison metformin hydrochloride CRS.C. Thin-layer chromatography(2.2.27).Test solution Dissolve 20 mg of the substance to be examined in water R and dilute to 5 ml with the same solvent.Reference solution Dissolve 20 mg of metformin hydrochloride CRS in water R and dilute to 5 ml with the same solvent.Plate TLC silica gel G plate R.Mobile phase Upper layer of a mixture of 10 volumes of glacial acetic acid R, 40 volumes of butanol R and 50 volumes of water R.Application 5 µl.Development Over a path of 15 cm.Drying At 100-105 °C for 15 min.Detection Spray with a mixture of equal volumes of a 100 g/l solution of sodium nitroprusside R, a 100 g/l solution of potassium ferricyanide R and a 100 g/l solution of sodium hydroxide R, prepared 20 min before use.Results The principal spot in the chromatogram obtained with the test solution is similar in position, colour and size to the principal spot in the chromatogram obtained with the reference solution.D. Dissolve about 5 mg in water R and dilute to 100 ml with the same solvent. To 2 ml of the solution add 0.25 ml of strong sodium hydroxide solution R and 0.10 ml of α-naphthol solution R. Mix and allow to stand in iced water for 15 min. Add 0.5 ml of sodium hypobromite solution R and mix. A pink colour develops.E. It gives reaction (a) of chlorides(2.3.1).TESTSSolution SDissolve 2.0 g in water R and dilute to 20 ml with the same solvent.Appearance of solutionSolution S is clear (2.2.1) and colourless (2.2.2, Method II).Related substancesLiquid chromatography(2.2.29).Test solution Dissolve 0.50 g of the substance to be examined in the mobile phase and dilute to 100.0 ml with the mobile phase.Reference solution (a) Dissolve 20.0 mg of cyanoguanidine R in water R and dilute to 100.0 ml with the same solvent. Dilute 1.0 ml to 200.0 ml with the mobile phase.Reference solution (b) Dilute 1.0 ml of the test solution to 50.0 ml with the mobile phase. Dilute 1.0 ml of this solution to 20.0 ml with the mobile phase.Reference solution (c) Dissolve 10.0 mg of melamine R in about 90 ml of water R. Add 5.0 ml of the test solution and dilute to 100.0 ml with water R. Dilute 1.0 ml of this solution to 50.0 ml with the mobile phase.Column:∙— size: l = 0.25 m, Ø = 4.6 mm;∙— stationary phase: irregular, porous silica gel to which benzenesulphonic acid groups have been chemically bonded (10 µm); Or∙— size: l = 0.11 m, Ø = 4.7 mm;∙— stationary phase: regular, porous silica gel to which benzenesulphonic acid groups have been chemically bonded (5 µm).Mobile phase 17 g/l solution of ammonium dihydrogen phosphate R adjusted to pH 3.0 with phosphoric acid R.Flow rate 1 ml/min.Detection Spectrophotometer at 218 nm.Injection 20 µl.Run time Twice the retention time of metformin hydrochloride. System suitability Reference solution (c):∙—resolution: minimum of 10 between the peaks due to melamine and to metformin hydrochloride.Limits:∙—impurity A: not more than the area of the corresponding peak in the chromatogram obtained with reference solution (a) (0.02 per cent);∙—any other impurity: not more than the area of the principal peak in the chromatogram obtained with reference solution (b) (0.1 per cent).Heavy metals(2.4.8)Maximum 10 ppm.12 ml of solution S complies with limit test A. Prepare the standard using lead standard solution (1 ppm Pb) R.Loss on drying(2.2.32)Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105 °C for 5 h.Sulphated ash(2.4.14)Maximum 0.1 per cent, determined on 1.0 g.ASSAYDissolve 0.100 g in 4 ml of anhydrous formic acid R. Add 80 ml of acetonitrile R. Carry out the titration immediately. Titrate with 0.1 M perchloric acid, determining the end-point potentiometrically(2.2.20).1 ml of 0.1 M perchloric acid is equivalent to 16.56 mg of C4H12ClN5.IMPURITIESSpecified impurities A.Other detectable impurities (The following substances would, if present at a sufficient level, be detected by one or other of the tests in the monograph. They are limited by the general acceptance criterion for other/unspecified impurities and/or by the general monograph Substances for pharmaceutical use(2034). It is therefore not necessary to identify these impurities for demonstration of compliance. See also 5.10. Control of impurities in substances for pharmaceutical use): B, C, D, E, FAppendix I E. Chemical and Biological Reference MaterialsWhere the letters BPCRS appear after the name of a substance in a test or assay, the British Pharmacopoeia Chemical Reference Substance is to be used. A comprehensive and up-to-date list of British Pharmacopoeia Chemical Reference Substances, together with terms of trade and supply, is available on the website at. A printed catalogue and the substances are obtainable from the BPCRS Sales Office, Market Towers, 1 Nine Elms Lane, London SW8 5NQ, United Kingdom (telephone +44(0)20 7084 2561, facsimile +44 (0)20 7084 2566,e-mail: bpcrs@).In addition to BPCRS, monographs of the British Pharmacopoeia may also refer to reference substances available from other suppliers. These are denoted by the letters CRS.Where the letters CRS or EPCRS appear, the chemical reference substance issued by the European Pharmacopoeia Commission is to be used; where the letters BRP or EPBRP appear, the Biological Reference Preparation issued by the European Pharmacopoeia Commission is to be used. A printed catalogue and the substances, as well as European Pharmacopoeia infrared reference spectra, are obtainable from the Council of Europe, European Directorate for the Quality of Medicines & Healthcare, CRS Sales Team, 7 allée Kastner, CS 30026, F-67081, Strasbourg Cedex, France (facsimile +33 (0)3 88 41 27 71, e-mail: crs@).Other sources of specific reference substances are shown below.Astragaloside I CRS , Astragaloside II CRS , Astragaloside IV CRS , Paeonol CRS , Rosmarinic acid CRS , Salvianolic Acid B CRS ,CRS , Withaferin A CRS , Withanolide A CRS , Tanshinone IIAWithanolide B CRS , Z-Ligustilide CRS may be obtained from the Office of Reference Materials, LGC Standards, Queen's Road, Teddington, TW11 0LY, United Kingdom (telephone +44 (0)20 8943 8480, facsimile +44 (0)20 8943 7554,e-mail: uksales@).Opacity, Standard Preparation of The Standard Preparation is the 5th International Reference Preparation, established in 1975, and consists of a rod of plastic simulating the optical properties ofa bacterial suspension (10 Units of opacity). It may be obtained from the National Institute for Biological Standards and Control (NIBSC), Blanche Lane, South Mimms, Potters Bar, Hertfordshire, EN6 3QG, United Kingdom (telephone +44 (0)1707 641000,e-mail: enquiries@).Piperonyl Butoxide CRS may be obtained from the Office of Reference Materials, LGC Promochem, Queen's Road, Teddington, TW11 0LY, United Kingdom (telephone +44 (0)20 8943 8480,facsimile +44 (0)20 8943 7554,e-mail: uksales@).© Crown Copyright 2009Appendix III D. Liquid Chromatography(Ph. Eur. method 2.2.29)Liquid chromatography (LC) is a method of chromatographic separation based on the difference in the distribution of species between two non-miscible phases, in which the mobile phase is a liquid which percolates through a stationary phase contained in a column.LC is mainly based on mechanisms of adsorption, mass distribution, ion exchange, size exclusion or stereochemical interaction.ApparatusThe apparatus consists of a pumping system, an injector, a chromatographic column (a column temperature controller may be used), a detector and a data acquisition system (or an integrator or a chart recorder). The mobile phase is supplied from one or several reservoirs and flows through the column, usually at a constant rate, and then through the detector.Pumping systemsLC pumping systems are required to deliver the mobile phase at aconstant flow rate. Pressure fluctuations are to be minimised, e.g. by passing the pressurised solvent through a pulse-dampening device. Tubing and connections are capable of withstanding the pressures developed by the pumping system. LC pumps may be fitted with a facility for "bleeding" the system of entrapped air bubbles.Microprocessor controlled systems are capable of accurately delivering a mobile phase of either constant (isocratic elution) or varying composition (gradient elution), according to a defined programme. In the case of gradient elution, pumping systems which deliver solvent(s) from several reservoirs are available and solvent mixing can be achieved on either the low or high-pressure side of the pump(s).InjectorsThe sample solution is introduced into the flowing mobile phase at or near the head of the column using an injection system which can operate at high pressure. Fixed-loop and variable volume devices operated manually or by an auto-sampler are used. Manual partial filling of loops may lead to poorer injection volume precision.Stationary phasesThere are many types of stationary phases employed in LC, including: ∙— silica, alumina or porous graphite, used in normal-phasechromatography, where the separation is based on differences in adsorption and/or mass distribution,∙— resins or polymers with acid or basic groups, used in ion-exchange chromatography, where separation is based oncompetition between the ions to be separated and those in the mobile phase,∙— porous silica or polymers, used in size-exclusion chromatography, where separation is based on differencesbetween the volumes of the molecules, corresponding to steric exclusion,∙— a variety of chemically modified supports prepared from polymers, silica or porous graphite, used in reversed-phase LC, where the separation is based principally on partition of the molecules between the mobile phase and the stationaryphase,— special chemically modified stationary phases, e.g.cellulose or amylose derivatives, proteins or peptides,cyclodextrins etc., for the separation of enantiomers (chiral chromatography).Most separations are based upon partition mechanisms utilising chemically modified silica as the stationary phase and polar solvents as the mobile phase. The surface of the support, e.g. the silanol groups of silica, is reacted with various silane reagents to produce covalently bound silyl derivatives covering a varying number of active sites on the surface of the support. The nature of the bonded phase is an important parameter for determining the separation properties of the chromatographic system.Commonly used bonded phases are shown below:octyl = Si-[CH2]7-CH3C8octadecyl = Si-[CH2]17-CH3C18phenyl = Si-[CH2]n-C6H5C6H5cyanopropyl = Si-[CH2]3-CN CNaminopropyl = Si-[CH2]3-NH2NH2diol = Si-[CH2]3-O-CH(OH)-CH2-OHUnless otherwise stated by the manufacturer, silica based reversed-phase columns are considered to be stable in mobile phases having an apparent pH in the range 2.0 to 8.0. Columns containing porous graphite or particles of polymeric materials such as styrene-divinylbenzene copolymer are stable over a wider pH range.Analysis using normal-phase chromatography with unmodified silica, porous graphite or polar chemically modified silica, e.g. cyanopropyl or diol, as the stationary phase with a non-polar mobile phase is applicable in certain cases.For analytical separations, the particle size of the most commonly used stationary phases varies between 3 µm and 10µm. The particles may be spherical or irregular, of varying porosity and specific surface area. These parameters contribute to the chromatographic behaviour of a particular stationary phase. In the case of reversed phases, the nature of the stationary phase, the extent of bonding, e.g. expressed as the carbon loading, and whether the stationaryphase is end-capped (i.e. residual silanol groups are silylated) are additional determining factors. Tailing of peaks, particularly of basic substances, can occur when residual silanol groups are present.Columns, made of stainless steel unless otherwise prescribed in the monograph, of varying length and internal diameter (Ø) are used for analytical chromatography. Columns with internal diameters of less than 2 mm are often referred to as microbore columns. The temperature of the mobile phase and the column must be kept constant during an analysis. Most separations are performed at room temperature, but columns may be heated to give higher efficiency. It is recommended that columns not be heated above 60 °C because of the potential for stationary phase degradation or changes occurring to the composition of the mobile phase.Mobile phasesFor normal-phase chromatography, less polar solvents are employed. The presence of water in the mobile phase is to be strictly controlled to obtain reproducible results. In reversed-phase LC, aqueous mobile phases, with or without organic modifiers, are employed.Components of the mobile phase are usually filtered to remove particles greater than 0.45 µm. Multicomponent mobile phases are prepared by measuring the required volumes (unless masses are specified) of the individual components, followed by mixing. Alternatively, the solvents may be delivered by individual pumps controlled by proportioning valves by which mixing is performed according to the desired proportion. Solvents are normally degassed before pumping by sparging with helium, sonication or using on-line membrane/vacuum modules to avoid the creation of gas bubbles in the detector cell.Solvents for the preparation of the mobile phase are normally free of stabilisers and are transparent at the wavelength of detection, if an ultraviolet detector is employed. Solvents and other components employed are to be of appropriate quality. Adjustment of the pH, if necessary, is effected using only the aqueous component of the mobile phase and not the mixture. If buffer solutions are used, adequate rinsing of the system is carried out with a mixture of water and the organic modifier of the mobile phase (5 per cent V/V) to prevent crystallisation of salts after completion of the chromatography.Mobile phases may contain other components, e.g. a counter-ion for ion-pair chromatography or a chiral selector for chromatographyusing an achiral stationary phase.DetectorsUltraviolet/visible (UV/Vis) spectrophotometers, including diode array detectors, are the most commonly employed detectors. Fluorescence spectrophotometers, differential refractometers, electrochemical detectors, mass spectrometers, light scattering detectors, radioactivity detectors or other special detectors may also be used.MethodEquilibrate the column with the prescribed mobile phase and flow rate, at room temperature or at the temperature specified in the monograph, until a stable baseline is achieved. Prepare the solution(s) of the substance to be examined and the reference solution(s) required. The solutions must be free from solid particles.Criteria for assessing the suitability of the system are described in the chapter on Chromatographic separation techniques (2.2.46). The extent to which adjustments of parameters of the chromatographic system can be made to satisfy the criteria of system suitability are also given in this chapter.Additional points for monographs of the British PharmacopoeiaThe composition and flow rate of the mobile phase are stated in the monograph. It is advisable to use as the mobile phase solvent mixtures that have been de-aerated using a vacuum pump or other suitable means of de-aeration that has no effect on the composition of the mixture.In quantitative work, particularly where the use of an internal standard is not specified in the monograph, the use of a fixed-volume loop injector is recommended. In certain exceptional cases the use of peak heights alone is prescribed in the monograph; where this is the case peak heights should be used irrespective of the symmetry factor.The column is usually made of stainless steel and its dimensions are stated in the monograph. The dimensions are stated as (length × internal diameter). When the monograph prescribes the use of a stationary phase designated by a letter, the relevant stationary phase defined below is intended. The nominal diameter of theparticles of the stationary phase is stated in parentheses immediately following the designating letter. In most cases reference is made to a particular commercial brand that has been found to be suitable for the purpose, but such statements do not imply that a different but equivalent commercial brand may not be used. The separation should be carried out at a constant ambient temperature unless otherwise specified in the monograph. When using mobile phases of high pH with a silica-based column, it is advisable to use a pre-column before the analytical column.Unless otherwise specified in the monograph the detector consists of a photometric detector fitted with a low-volume flow cell (about 10 µl i s suitable); the wavelength setting is specified in the monograph.The design of a particular chromatograph may require modification of the conditions detailed in the monograph. In such a case the analyst should be satisfied that the modified conditions produce comparable results.injection volumeWhere no injection volume is specified in the monograph, the analyst should select an appropriate volume for their specific application. The volume chosen is dependent on the response of the analyte, the detector used, the efficiency of the column and the overall performance of the chromatographic system. Where a volume is not indicated, 20 µl is usually appropriate; however this should be checked for suitability under the local operating conditions.run timeWhere no run time is specified in the monograph, the analyst should select an appropriate run time for their specific application. The run time chosen is dependent on the type of test. For example, where a run time is not indicated in a Related substances test the analyst should ensure that the run time is greater than all known or likely secondary peaks; similarly in an Assay the run time should be chosen to allow the baseline to stabilise following the elution of the peak of interest.secondary peaksReference may be made to secondary peaks. A secondary peak is a peak in the chromatogram other than the principal peak and any peak dueto internal standard, solvent or derivatising agents. Peaks identified as being due to the counter-ion and/or other excipients including preservatives in the material being examined may also be excluded.materialsSolvents and reagents used in the preparation of solutions for examination should be of a quality suitable for use in liquid chromatography.© Crown Copyright 2009Appendix VIII B. Amperometric and Potentiomeric TitrationsAmperometric Titration(Ph. Eur. method 2.2.19)In amperometric titration the end-point is determined by following the variation of the current measured between 2 electrodes (either one indicator electrode and one reference electrode or 2 indicator electrodes) immersed in the solution to be examined and maintained at a constant potential difference as a function of the quantity of titrant added.The potential of the measuring electrode is sufficient to ensure a diffusion current for the electroactive substance.Apparatus The apparatus comprises an adjustable voltage source and a sensitive microammeter; the detection system generally consists of an indicator electrode (for example, a platinum electrode, a dropping-mercury electrode, a rotating-disc electrode or a carbon electrode) and a reference electrode (for example, a calomel electrode or a silver-silver chloride electrode).A three-electrode apparatus is sometimes used, consisting of an indicator electrode, a reference electrode and a polarised auxiliaryelectrode.Method Set the potential of the indicator electrode as prescribed and plot a graph of the initial current and the values obtained during the titration as functions of the quantity of titrant added. Add the titrant in not fewer than 3 successive quantities equal to a total of about 80 per cent of the theoretical volume corresponding to the presumed equivalence point. The 3 values must fall on a straight line. Continue adding the titrant beyond the presumed equivalence point in not fewer than 3 successive quantities. The values obtained must fall on a straight line. The point of intersection of the 2 lines represents the end-point of the titration.For amperometric titration with 2 indicator electrodes, the whole titration curve is recorded and used to determine the end-point.Potentiometric Titration(Ph. Eur. method 2.2.20)In a potentiometric titration the end-point of the titration is determined by following the variation of the potential difference between 2 electrodes (either one indicator electrode and one reference electrode or 2 indicator electrodes) immersed in the solution to be examined as a function of the quantity of titrant added.The potential is usually measured at zero or practically zero current.Apparatus The apparatus used (a simple potentiometer or electronic device) comprises a voltmeter allowing readings to the nearest millivolt.The indicator electrode to be used depends on the substance to be determined and may be a glass or metal electrode (for example, platinum, gold, silver or mercury). The reference electrode is generally a calomel or a silver-silver chloride electrode.For acid-base titrations and unless otherwise prescribed, aglass-calomel or glass-silver-silver chloride electrode combination is used.Method The solvent mixture is neutralised, if necessary, before dissolution of the substance to be examined. Plot a graph of the variation of potential difference as a function of the quantity ofthe titrant added, continuing the addition of the titrant beyond the presumed equivalence point. The end-point corresponds to a sharp variation of potential difference.Determination of Primary Aromatic Amino-nitrogen(Ph. Eur method 2.5.8)Dissolve the prescribed quantity of the substance to be examined in50 ml of dilute hydrochloric acid R or in another prescribed solventand add 3 g of potassium bromide R. Cool in ice-water and titrateby slowly adding 0.1 M sodium nitrite with constant stirring.Determine the end-point electrometrically or by the use of the prescribed indicator.© Crown Copyright 2009Substances for Pharmaceutical UseGeneral Notices(Ph Eur monograph 2034)Ph EurDEFINITIONSubstances for pharmaceutical use are any organic or inorganic substances that are used as active substances or excipients for the production of medicinal products for human or veterinary use. They may be obtained from natural sources or produced by extraction from raw materials, fermentation or synthesis.This general monograph does not apply to herbal drugs, herbal drugs for homoeopathic preparations, herbal drug preparations, extracts, or mother tinctures for homoeopathic preparations, which are the subject of separate general monographs (Herbal drugs (1433), Herbal drugs forhomoeopathic preparations (2045), Herbal drug preparations (1434), Extracts (0765), Mother tinctures for homoeopathic preparations (2029)). It does not apply to raw materials for homoeopathic preparations, except where there is an individual monograph for the substance in thenon-homoeopathic part of the Pharmacopoeia.Where a substance for pharmaceutical use not described in an individual monograph of the Pharmacopoeia is used in a medicinal product prepared for the special needs of individual patients, the need for compliance with the present general monograph is decided in the light of a risk assessment that takes account of the available quality of the substance and its intended use.Where medicinal products are manufactured using substances for pharmaceutical use of human or animal origin, the requirements of chapter 5.1.7. Viral safety apply.Substances for pharmaceutical use may be used as such or as starting materials for subsequent formulation to prepare medicinal products. Depending on the formulation, certain substances may be used either as active substances or as excipients. Solid substances may be compacted, coated, granulated, powdered to a certain fineness, or processed in other ways. A monograph is applicable to a substance processed with an excipient only where such processing is mentioned in the definition section of the monograph.Substance for pharmaceutical use of special grade Unless otherwise indicated or restricted in the individual monographs, a substance for pharmaceutical use is intended for human and veterinary use, and is of appropriate quality for the manufacture of all dosage forms in which it can be used.Polymorphism Individual monographs do not usually specify crystalline or amorphous forms, unless bioavailability is affected. All forms of a substance for pharmaceutical use comply with the requirements of the monograph, unless otherwise indicated.PRODUCTIONSubstances for pharmaceutical use are manufactured by procedures that are designed to ensure a consistent quality and comply with the requirements of the individual monograph or approved specification.The provisions of general chapter 5.10 apply to the control of impurities in substances for pharmaceutical use.Whether or not it is specifically stated in the individual monograph that the substance for pharmaceutical use:∙— is a recombinant protein or another substance obtained as a direct gene product based on genetic modification, where applicable, the substance also complies with the requirements of the general monograph Products of recombinant DNA technology (0784);∙—is obtained from animals susceptible to transmissible spongiform encephalopathies other than by experimental challenge, whereapplicable, the substance also complies with the requirements of the general monograph Products with risk of transmitting agents of animal spongiform encephalopathies (1483);∙— is a substance derived from a fermentation process, whether or not the micro-organisms involved are modified by traditionalprocedures or recombinant DNA(rDNA) technology, where applicable, the substance also complies with the requirements of the general monograph Products of fermentation (1468).If solvents are used during production, they are of suitable quality. In addition, their toxicity and their residual level are taken into consideration (5.4). If water is used during production, it is of suitable quality.If substances are produced or processed to yield a certain form or grade, that specific form or grade of the substance complies with the requirements of the monograph. Certain functionality-related tests may be described to control properties that may influence the suitability of the substance and subsequently the properties of dosage forms prepared from it.Powdered substances may be processed to obtain a certain degree of fineness (2.9.35).Compacted substances are processed to increase the particle size or to obtain particles of a specific form and/or to obtain a substance with a higher bulk density.Coated active substances consist of particles of the active substance coated with one or more suitable excipients.Granulated active substances are particles of a specified size and/or form produced from the active substance by granulation directly or with one or more suitable excipients.。
盐酸二甲双胍质量标准
北京中惠药业有限公司文件分类：体系程序性文件-质量标准文件名称：盐酸二甲双胍质量标准文件编码：SOP-QS001-00页码：第1页共5页制定人审核人批准人签名日期姓名康敬苏曼利窦豆职务质检员质检主管质量管理部经理执行日期：2013年06月01日分发范围：质量管理部、质监室、质检室、物流部文件变更记载文件编码文件名称变更历史及原因执行日期JS·ZL002-04盐酸二甲双胍质量标准根据《药品生产质量管理规范》2010版和《质量标准类文件的编制和标准》（GL·WJ009-02）进行变更。
2012年10月01日SOP-QS001-00盐酸二甲双胍质量标准增加“红外图谱的附图”：文件格式发生变化。
2013年06月01日1 目的：制定盐酸二甲双胍的质量标准，使盐酸二甲双胍的采购、验收、检验、贮存、使用有据可依，保证产品的质量。
2 范围：适用于盐酸二甲双胍的采购、验收、检验、贮存、使用各岗位。
3 职责3.1 物流部：按本标准进行采购、验收和贮存。
3.2 质监室：监督检查以下项目并对该物料行使放行审核权。
3.2.1 物流部是否按本标准进行采购、验收和贮存；3.2.2 取样员是否按抽样程序对待检物料进行取样；3.2.3 质检室是否按本标准进行检验。
3.3 质检室：按本标准进行检验，并及时出具检验报告。
4 内容4.1 物料基本信息4.1.1 物料名称: 盐酸二甲双胍；物料编码：Y010；4.1.2 质量标准的依据: 《中国药典》2010版二部；4.1.3 经批准的合格供应商：天津太平洋化学制药有限公司 ,淮南佳盟药业有限公司4.2 取样方法：取样执行《取样管理规程》（SMP-QA011-00）。
4.3检验项目、方法及可接受标准4.3.1 性状4.3.1.1本品应为白色结晶或结晶性粉末；无臭。
4.3.1.2本品在水中易溶，在甲醇中溶解，在乙醇中微溶，在三氯甲烷或乙醚中不溶。
4.3.1.3 熔点：照《熔点测定法标准操作规程》（SOP-TP012-00）操作，应为220～225℃。
盐酸二甲双胍片说明书
肾功能: 慢性肾脏病变是糖尿病的常见并发症，一旦确诊糖尿病，应常规检查肾功能。二甲双胍经过肾脏排 泄，随着肾功能受损的程度的增加，二甲双胍蓄积和发生乳酸酸中毒的危险性随之增加。开始治疗前以及 治疗后应至少每年检查肾功能。 本品禁用于 eGFR<45mL/min/1.73m2 的患者。出现脱水、严重感染或休克等影响肾功能的急性病情的 患者应暂时停用本品（见【禁忌】）。 心功能: 心衰患者缺氧和肾功能不全的风险更高。稳定性慢性心衰的患者在定期检查心、肾功能的情况下可 以服用二甲双胍。 二甲双胍禁用于急性和不稳定性心衰的患者（见【禁忌】）。 碘化造影剂的使用: 向血管内注射碘化造影剂可能导致造影剂肾病，这可能引起二甲双胍蓄积和增加乳酸酸中毒的风险。 因此，计划做这类检查的患者，在检查前或检查时必须停止服用二甲双胍，在检查完成至少 48 小时后且 仅在再次检查肾功能稳定的情况下才可以恢复用药。 外科手术: 在接受常规、脊髓或硬膜外麻醉的手术时必须停止服用二甲双胍。术后至少 48 小时或恢复进食并且 肾功能经评估稳定后才可以重新开始治疗。 其他注意事项: 所有患者应继续合理安排碳水化合物的饮食摄入。超重患者应继续热量限制性饮食。 应定期进行常规实验室检查以监测糖尿病。 维生素 B12 水平——某些患者(那些摄入或吸收维生素 B12 和钙不足的患者)可能更容易发生维生素 B12 水平的降低。这种患者每隔 2－3 年测定一次血清维生素 B12 水平是有益的。 低血糖——单独接受本品治疗的患者正常情况下不会产生低血糖，但与胰岛素或其他降糖药物(例如 磺脲类药物或格列奈类药物) 联合使用应警惕低血糖。老年、衰弱或营养不良的患者，以及肾上腺和垂体 功能低减、酒精中毒的患者更易发生低血糖。 儿童——在开始二甲双胍治疗前应确诊 2 型糖尿病。据国外文献报道，为期 1 年的临床对照研究尚
盐酸二甲双胍质量标准
北京中惠药业有限公司文件分类：体系程序性文件-质量标准文件名称：盐酸二甲双胍质量标准文件编码：SOP-QS001-00页码：第1页共5页制定人审核人批准人签名日期姓名康敬苏曼利窦豆职务质检员质检主管质量管理部经理执行日期：2013年06月01日分发范围：质量管理部、质监室、质检室、物流部文件变更记载文件编码文件名称变更历史及原因执行日期JS·ZL002-04盐酸二甲双胍质量标准根据《药品生产质量管理规范》2010版和《质量标准类文件的编制和标准》（GL·WJ009-02）进行变更。
2012年10月01日SOP-QS001-00盐酸二甲双胍质量标准增加“红外图谱的附图”：文件格式发生变化。
2013年06月01日1 目的：制定盐酸二甲双胍的质量标准，使盐酸二甲双胍的采购、验收、检验、贮存、使用有据可依，保证产品的质量。
2 范围：适用于盐酸二甲双胍的采购、验收、检验、贮存、使用各岗位。
3 职责3.1 物流部：按本标准进行采购、验收和贮存。
3.2 质监室：监督检查以下项目并对该物料行使放行审核权。
3.2.1 物流部是否按本标准进行采购、验收和贮存；3.2.2 取样员是否按抽样程序对待检物料进行取样；3.2.3 质检室是否按本标准进行检验。
3.3 质检室：按本标准进行检验，并及时出具检验报告。
4 内容4.1 物料基本信息4.1.1 物料名称: 盐酸二甲双胍；物料编码：Y010；4.1.2 质量标准的依据: 《中国药典》2010版二部；4.1.3 经批准的合格供应商：天津太平洋化学制药有限公司 ,淮南佳盟药业有限公司4.2 取样方法：取样执行《取样管理规程》（SMP-QA011-00）。
4.3检验项目、方法及可接受标准4.3.1 性状4.3.1.1本品应为白色结晶或结晶性粉末；无臭。
4.3.1.2本品在水中易溶，在甲醇中溶解，在乙醇中微溶，在三氯甲烷或乙醚中不溶。
4.3.1.3 熔点：照《熔点测定法标准操作规程》（SOP-TP012-00）操作，应为220～225℃。
盐酸二甲双胍的成分
盐酸二甲双胍的成分
盐酸二甲双胍是一种用于治疗糖尿病的药物。
它的药理作用是通过降低肝脏葡萄糖的
产生和增加细胞对葡萄糖的利用，从而控制血糖水平。
盐酸二甲双胍的化学名称为
1,1-dimethylbiguanide hydrochloride，化学式为C4H11N5·HCl，相对分子质量为
165.6。
盐酸二甲双胍是一种白色结晶粉末，在水中易溶解，微溶于乙醇，难溶于氯仿。
它是
一种碱性化合物，i pKa为12.4。
盐酸二甲双胍是一种双胍类药物，包含两个甲基双胍分子。
双胍类药物存在对血糖的
调节显著作用，特别是在糖尿病治疗中，以降低糖尿病 II 型患者血糖水平得到广泛应用。
它被认为是一种具有潜在药理活性的药物，可以通过活化AMP激酶和Akt等信号通路，而
促进机体合成蛋白质并提高氧化磷酸化水平，从而通过降低自由脂肪酸含量和改善葡萄糖
和脂肪酸代谢来控制糖尿病。
盐酸二甲双胍在治疗糖尿病方面的作用主要是两个方面：首先它抑制糖异生，降低血
糖水平；其次通过增加谷氨酸基转移酶(GPT)活性，减少血清丙氨酸转移酶(AST)含量，从
而减轻肝脏负担。
同时，它还具有细胞保护作用，能够捕获氧自由基，并可抑制脂肪合成
和胆固醇的生合成，并在中等和高剂量时减少血浆三酰甘酸和胆固醇的含量。
在临床上，盐酸二甲双胍通常作为单药或联合用药（如二甲双胍和磺酰脲类药物等）
来治疗糖尿病。
治疗糖尿病的有效剂量范围为一天两次500mg至850mg。
但在使用盐酸二
甲双胍时，必须注意掌握好用药剂量、使用时机等因素，以最大程度发挥药物疗效，避免
出现不良反应。
2024版中国药典方法对盐酸二甲双胍液相色谱解决方案
2024版中国药典方法对盐酸二甲双胍液相色谱解决方案盐酸二甲双胍（Metformin hydrochloride）是一种常用的口服降糖药物，主要用于治疗糖尿病。
其化学结构如下所示：盐酸二甲双胍盐酸二甲双胍常常作为原料药使用，因此对其质量的控制十分重要。
中国药典是我国制定的药品质量标准，其中包含了对盐酸二甲双胍的质量要求和检测方法。
盐酸二甲双胍的液相色谱检测方法主要包括以下几个方面。
首先是色谱柱的选择，常用的是C18柱，如Agilent Zorbax SB-C18柱，Phenomenex Luna C18柱等。
其次是流动相的选择，常用的有甲醇-水、乙腈-水等。
流动相的pH值可以用磷酸调节，一般为2.5、再次是检测波长的选择，常用的是220nm或230nm。
在进行液相色谱分析时，首先需将盐酸二甲双胍溶解于适当的溶剂中，然后通过过0.22μm的微孔滤膜滤除杂质。
将过滤后的样品注入到色谱柱中，通过梯度洗脱的方法进行分离。
流经柱的组分会根据其亲水性和极性不同，在色谱柱中保留不同的时间，最终通过检测器进行测定。
在测定过程中，需要进行系统适应性试验，了解色谱条件是否稳定，分辨率是否满足要求。
仪器校准和标准曲线的绘制也是必不可少的。
将含有不同浓度盐酸二甲双胍的标准溶液，经过色谱柱进行分离，测定其峰面积。
将峰面积和浓度之间进行线性拟合，得到标准曲线方程，从而可以通过峰面积对样品中盐酸二甲双胍的含量进行定量测定。
在进行样品测定前，还需进行样品制备步骤，包括提取和清洗。
提取步骤一般使用溶剂提取法，将样品与溶剂充分混合后，通过离心或振荡摇动进行萃取。
清洗步骤主要是去除样品中的杂质，包括胶体、大分子物质、脂质等。
常见的清洗方法有凝胶过滤、固相萃取等。
在进行方法验证时，需要考察盐酸二甲双胍的线性范围、灵敏度、稳定性、精密度和准确度等指标。
线性范围一般为0.5-10 mg/mL，灵敏度可通过LOD（限制检测限）和LOQ（定量检测限）进行评估。
欧洲药典盐酸二甲双胍杂质F二甲胺检测方法
欧洲药典中盐酸二甲双胍杂质F（二甲胺检测方法）翻译
衍生试剂：现配现用，1ml2,4-二氟硝基苯至100ml容量瓶中，用乙腈（HLPC级）溶解。
空白溶液：取100ul三乙胺和1ml衍生试剂加入到5ml乙腈中，摇匀，60℃加热30min，冷却后，用乙腈定容至10ml。
供试品溶液：现配现用，10mg盐酸二甲双胍原料药，用5ml乙腈溶解，超声5min，加入100ul三乙胺和1ml衍生试剂，摇匀，60℃加热30min，冷却后，用乙腈定容至10ml。
用前过滤或者在（离心力）800g的转速下离心5min。
对照溶液：取1ml二甲胺至100ml容量瓶中，用乙腈溶解并定容至刻度，然后移取此溶液2.5ml此溶液至100ml容量瓶中，用乙腈溶解并定容。
取上述溶液1ml，加入5ml乙腈，在加入100ui三乙胺，摇匀，60℃加热30min，冷却后，用乙腈定容至10ml。
色谱柱：以封尾的碳十八烷基键合硅胶为固定相，规格：125mm×3mm×5um 柱温：30℃，流速：0.7ml/min，检测波长：380nm，进样量：5ul。
流动相A：0.1%磷酸（体积比）
流动相B：乙腈
洗脱梯度：
鉴别峰：对比空白图谱和对照谱图，确定杂质F衍生峰。
杂质F分离度保留时间约为4min。
系统适用性要求：与杂质F衍生峰最近的峰的分离度不得小于3.0。
限度：供试品中杂质F衍生峰的峰面积不得大于对照品溶液中杂质F衍生峰的峰面积的0.05%。
盐酸二甲双胍
日文名：塩酸メトフォルミン
英文名：MetforminHydrochloride
结构式：
解离常数：pKa=12.4（针对仲氨基）
在各溶出介质中的溶解度(37℃)：
pH1.2：333mg/ml
pH4.0：353mg/ml
pH6.8：355mg/ml
水：346mg/ml
在各溶出介测定。
光：未测定。
《四条标准溶出曲线》
溶出度试验条件：桨板法/50转、溶出介质中不添加表面活性剂。
<250mg规格片剂>A型
<250mg规格片剂>B型
《质量标准》
取本品，照溶出度测定法（桨板法），以水900ml为溶剂，转速为每分钟50转，依法操作，经120分钟（A型）或15分钟（B型）时，取溶液适量滤过，弃去至少10ml初滤液，精密量取续滤液适量，加水稀释制成每1ml中含5.6μg的溶液，作为供试品溶液。另精密称取预经105℃干燥3小时的盐酸二甲双胍对照品0.028g，置200ml量瓶中，加水溶解并稀释至刻度，摇匀，精密量取4ml，置100ml量瓶中，加水稀释至刻度，摇匀，作为对照品溶液。取上述两种溶液照紫外-可见分光光度法，分别在233nm波长处测定吸光度，计算每片的溶出量，限度为标示量的85%（A型）或80%（B型），应符合规定。
药用级盐酸二甲双胍医药级原料药医用药典级标准新货到了
药用级盐酸二甲双胍医药级原材料药医用药典级标准新货到了盐酸二甲双胍是一种常用的口服降糖药物，在治疗２型糖尿病方面具有广泛的应用。
药用级盐酸二甲双胍原材料药必需符合药典级标准，以确保其质量和安全性。
近期，药用级盐酸二甲双胍的新货已经到货。
这代表着市场上供应充分，可以充足医疗机构和药品生产企业的需求。
药用级盐酸二甲双胍的原材料药通常会依照不同规格和质量档次进行定价。
价格会受到多种因素的影响，包括原材料成本、市场竞争、品牌溢价等。
一般而言，药用级盐酸二甲双胍的价格相对稳定，不会显现大幅波动。
医药行业对盐酸二甲双胍的需求一直很高，随着人口老龄化和糖尿病患者数量的加添，对该药物的需求将会持续增长。
因此，药用级盐酸二甲双胍的新货到货，将会充足市场需求和扩大供应，为患者供给更好的治疗选择。
本品为１，１－二甲基双胍盐酸盐。
按干燥品计算，含Ｃ４Ｈ１１Ｎ５·ＨＣｌ不得少于９８．５％。
【性状】本品为白色结晶或结晶性粉末；无臭。
本品在水中易溶，在甲醇中溶解，在乙醇中微溶，中不溶。
熔点本品的熔点（通则０６１２）为２２０～２２５℃。
汲取系数取本品适量，精密称定，加水溶解并定量稀释制成每１ｍｌ中约含５＆ｍｉｃｒｏ；ｇ的溶液，照紫外－可见分光光度法（通则０４０１），在２３３ｎｍ的波优点测定吸光度，汲取系数（）为７７８～８１８。
【辨别】（１）取本品约１０ｍｇ，加水１０ｍｌ溶解后，加１０％亚硝液－１０％氢氧化钠溶液（等体积混合，放置２０分钟使用）１０ｍｌ，３分钟内溶液呈红色。
（２）本品的红外光汲取图谱应与对比的图谱（光谱集６３１图）一致。
（３）本品显氯化物的辨别反应（通则０３０１）。
【含量测定】取本品约６０ｍｇ，精密称定，加无水甲酸４ｍｌ使溶解，加醋酐５０ｍｌ，充分混匀，照电位滴定法（通则０７０１），用高氯酸滴定液（０．１ｍｏｌ／Ｌ）滴定，并将滴定的结果用空白试验校正。
每１ｍｌ高氯酸滴定液（０．１ｍｏｌ／Ｌ）相当于８．２８２ｍｇ的Ｃ４Ｈ１１Ｎ５·ＨＣｌ【类别】降血糖药。
中国药典版二部：盐酸二甲双胍片
中国药典版二部：盐酸二甲双胍片
药品名称盐酸二甲双胍片拼音名YansuanErjiashuangguaPian英文名MetflrminHydrochlorideTablets来源(分子式)与标准本品含盐酸二甲双胍
（C4H11N5.HCl）应为标示量的95.0％～105.0％。
性状
本品为糖衣或薄膜衣片，除去包衣后显白色。
检查
溶出度取本品，照溶出度测定法（附录ⅩC第一法），以水1000ml为溶剂，转速为每分钟100转，依法操作，经45分钟，取溶液10ml滤过，精密量取滤液2ml置100ml量瓶中，用水稀释至刻度，照分光光度法（附录ⅣA），在233nm的波长处测定吸收度，按C4H11N5.HCl的吸收度系数（Ｅ1cm1%）为798计算出每片的溶出量。
限度为标示量的70％应符合规定。
其它应符合片剂项下的各项规定（附录ⅠA）。
鉴别
(1)取本品细粉适量（约相当于盐酸二甲双胍50mg），加水10ml使盐酸二甲双胍溶解，滤过，照盐酸二甲双胍项下鉴别(1)(2)项试验，显相同的反应。
(2)取含量测定项下的溶液，照分光光度法（附录ⅣA）测定，在233nm的波长处有最吸收。
含量测定
取本品20片，精密称定，研细，精密称取适量（约相当于盐酸二甲双胍10mg），置100ml量瓶中，加水75ml，充分振摇15分钟，使盐酸二甲双胍溶解，加水稀释至刻度，摇匀，滤过，弃去初滤液，精密量取续滤液5ml，置100ml量瓶中，加水稀释至刻度，摇匀。
照光光度法（附录ⅣA），在233nm的波长处测定吸收度，按C4H11N5.HCl的吸收系数（Ｅ1cm1%）为798计算，即得。
类别同盐酸二甲双胍剂量同盐酸二甲双胍注意同盐酸二甲双胍规格0.25g贮藏密封保存。
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Metformin HydrochlorideC4H11N5·HCl 165.62Imidodicarbonimidic diamide,N,N-dimethyl-,monohydrochloride.1,1-Dimethylbiguanide monohydrochloride [1115-70-4].»Metformin Hydrochloride contains not less than 98.5percent and not more than 101.0percent of C4H11N5·HCl,calculated on the dried basis.USP Reference standards 〈11〉—USP Metformin Hydrochloride P Metformin Related Compound A RS.Identification—A:Infrared Absorption 〈197K〉.B:It meets the requirements of the tests for Chloride 〈191〉.Loss on drying 〈731〉—Dry it at 105for 5hours:it loses not more than 0.5%of its weight. Residue on ignition 〈281〉:not more than 0.1%.Heavy metals,Method I〈231〉:0.001%.Related compounds—Mobile phase—Prepare a solution in water,containing 17g of monobasic ammonium phosphate per L,adjust with phosphoric acid to a pHof 3.0,and mix.Standard solution—Prepare a solution of USP Metformin Related Compound A RSin water having a known concentration of about 0.2mg per mL.Transfer 1.0mLof this solution to a 200-mLvolumetric flask,dilute with Mobile phase to volume,and mix.[NOTE—Metformin related compound Ais 1-cyanoguanidine.]Test solution—Transfer about 500mg of Metformin Hydrochloride,accurately weighed,to a 100-mLvolumetric flask,dissolve in and dilute with Mobile phase to volume,and mix.Diluted test solution—Transfer 1.0mLof the Test solution to a 10-mLvolumetric flask,dilute with Mobile phase to volume,and mix.Transfer 1.0mLof this solution to a 100-mLvolumetric flask,dilute with Mobile phase to volume,and mix.Resolution solution—Transfer about 10mg of melamine to a 100-mLvolumetric flask,and dissolve in about 90mLof water.Add 5.0mLof the Test solution,dilute with water to volume,and mix.Transfer 1.0mLof this solution to a 50-mLvolumetric flask,dilute with Mobile phase to volume,and mix.Chromatographic system (see Chromatography 〈621〉)—The liquid chromatograph is equippedwith a 218-nm detector and a 4.6-mm ×25-cm column containing packing L9.The flow rate is about 1.0to 1.7mLper minute.Chromatograph the Resolution solution,and record the peak responses as directed for Procedure:the resolution,R,between melamine and metformin is not less than 10.Procedure—Separately inject equal volumes (about 20µL)of the Test solution,the Standard solution,and the Diluted test solution into the chromatograph,record the chromatograms for not less than twice the retention time of metformin,and measure the peak areas.The area of a peak corresponding to metformin related compound Ain the chromatogram of the Test solution is not greater than the area of the corresponding peak in the chromatogram of the Standard solution:not more than 0.02%of metformin related compound Ais found.The area of any other secondary peak in the chromatogram of the Test solution is not greater than the area of the major peak in the chromatogram of the Diluted test solution;and the sum of the areas of all secondary peaks in the chromatogram of the Test solution is not greater than five times the area of the major peak in the chromatogram of the Diluted test solution:not more than 0.1%of any other impurity is found;and not more than 0.5%of total impurities is found.Assay—[NOTE—To avoid overheating of the reaction medium,mix thoroughly throughout the titration,and stop the titration immediately after the endpoint has been reached.]Dissolve about 60mg of Metformin Hydrochloride,accurately weighed,in 4mLof anhydrous formic acid.Add 50mLof acetic anhydride.Titrate with 0.1Nperchloric acid VS,determining the endpoint potentiometrically.Perform a blank determination,and make any necessary correction (see Titrimetry 〈541〉).Each mLof 0.1Nperchloric acid is equivalent to 8.28mg of C4H11N5·P28Auxiliary Information—Staff Liaison:Elena Gonikberg,Ph.D.,ScientistExpert Committee:(PA4)Pharmaceutical Analysis 4USP28–NF23Page 1231Pharmacopeial Forum:V olume No.29(6)Page 1925Phone Number:1-301-816-8251Metformin Hydrochloride(Ph Eur monograph 0931)C4H11N5,HCl 165.61115-70-4Ph EurDEFINITION1,1-Dimethylbiguanide hydrochloride.Content98.5 per cent to 101.0 per cent (dried substance).CHARACTERSAppearanceWhite crystals.SolubilityFreely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene chloride.IDENTIFICATIONFirst identificationB, E.Second identificationA, C, D, E.A. Melting point (2.2.14): 222 C to 226 C.B. Infrared absorption spectrophotometry (2.2.24).Preparation. Discs of potassium chloride R.Comparison: Metformin hydrochloride CRS.C. Thin-layer chromatography (2.2.27).Test solution. Dissolve 20 mg of the substance to be examined in water R and dilute to 5 ml with the same solvent.Reference solution. Dissolve 20 mg of metformin hydrochloride CRS in water R and dilute to 5 ml with the same solvent.Plate. TLC silica gel G plate R.Mobile phase. Upper layer of a mixture of 10 volumes of glacial acetic acid R, 40 volumes of butanol R and 50 volumes of water R.Application. 5 µl.Development. Over a path of 15 cm.Drying. At 100C105 C for 15 min.Detection. Spray with a mixture of equal volumes of a 100 g/l solution of sodium nitroprusside R, a 100 g/l solution of potassium ferricyanide R and a 100 g/l solution of sodium hydroxide R, prepared 20 min before use.Results. The principal spot in the chromatogram obtained with the test solution is similar inposition, colour and size to the principal spot in the chromatogram obtained with the reference solution.D. Dissolve about 5 mg in water R and dilute to 100 ml with the same solvent. To 2 ml of the solution add 0.25 ml of strong sodium hydroxide solution R and 0.10 ml of a-naphthol solution R. Mix and allow to stand in iced water for 15 min. Add 0.5 ml of sodium hypobromite solution R and mix. A pink colour develops.E. It gives reaction (a) of chlorides (2.3.1).TESTSSolution SDissolve 2.0 g in water R and dilute to 20 ml with the same solvent.Appearance of solutionSolution S is clear (2.2.1) and colourless (2.2.2, Method II).Related substancesLiquid chromatography (2.2.29).Test solutionDissolve 0.50 g of the substance to be examined in the mobile phase and dilute to 100.0 ml with the mobile phase.Reference solution (a)Dissolve 20.0 mg of cyanoguanidine R in water R and dilute to 100.0 ml with the same solvent. Dilute 1.0 ml to 200.0 ml with the mobile phase.Reference solution (b)Dilute 1.0 ml of the test solution to 50.0 ml with the mobile phase. Dilute 1.0 ml of this solution to 20.0 ml with the mobile phase.Reference solution (c)Dissolve 10.0 mg of melamine R in about 90 ml of water R. Add 5.0 ml of the test solution and dilute to 100.0 ml with water R. Dilute 1.0 ml of this solution to 50.0 ml with the mobile phase.Column:size: l = 0.25 m, Ø = 4.6 mm,stationary phase: irregular, porous silica gel to which benzenesulphonic acid groups have been chemically bonded (10 µm),orsize: l = 0.11 m, Ø = 4.7 mm,stationary phase: regular, porous silica gel to which benzenesulphonic acid groups have been chemically bonded (5 µm).Mobile phase17 g/l solution of ammonium dihydrogen phosphate R adjusted to pH 3.0 with phosphoric acid R.Flow rate1 ml/min.DetectionSpectrophotometer at 218 nm.Injection20 µl.Run timeTwice the retention time of metformin hydrochloride.System suitabilityReference solution (c):resolution: minimum of 10 between the peaks due to melamine and to metformin hydrochloride.Limits:impurity A: not more than the area of the corresponding peak in the chromatogram obtained with reference solution (a) (0.02 per cent),any other impurity: not more than the area of the principal peak in the chromatogram obtained with reference solution (b) (0.1 per cent).Heavy metals (2.4.8)Maximum 10 ppm.12 ml of solution S complies with limit test A. Prepare the standard using lead standard solution (1 ppm Pb) R.Loss on drying (2.2.32)Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 100C105 C for 5 h. Sulphated ash (2.4.14)Maximum 0.1 per cent, determined on 1.0 g.ASSAYDissolve 0.100 g in 4 ml of anhydrous formic acid R. Add 80 ml of acetonitrile R. Carry out the titration immediately. Titrate with 0.1 M perchloric acid, determining the end-point potentiometrically (2.2.20).1 ml of 0.1 M perchloric acid is equivalent to 16.56 mg of C4H12ClN5.IMPURITIESQualified impuritiesA.Other detectable impuritiesB, C, D, E, F.A. cyanoguanidine,B. R = NH-C(=NH)-NH2: (4,6-diamino-1,3,5-triazin-2-yl)guanidine,C. R = N(CH3)2: N,N-dimethyl-1,3,5-triazine-2,4,6-triamine,D. R = NH2: 1,3,5-triazine-2,4,6-triamine (melamine),E. 1-methylbiguanide,F. CH3-NH-CH3: N-methylmethanamine.Ph EurAction and useHypoglycaemic.PreparationMetformin Tablets。