品种编号名称英文名或拉丁名100001 醋酸甲羟孕酮Medroxyprogesterone Acetate 100002 安乃近Metamizole Sodium 100003 2-氨基丁醇2-Aminobutanol 100004 苯丙酸诺龙Nandrolone Phenylpropionate 100005 苯丁酸氮芥Chlorambucil 100006 苯甲酸雌二醇Estradiol Benzoate 100008 丙酸睾酮Testosterone Propionate 100010 醋酸氟氢松Fluocinonide 100011 醋酸氯地孕酮Chlormadinone Acetate 100012 醋酸泼尼松Prednisone Acetate 100013 醋酸氢化可的松Hydrocortisone Acetate 100015 地高辛Digoxin 100016 地塞米松磷酸钠Dexamethasone Sodium Phosphate 100017 对氨基苯甲酸P-Aminobenzoic Acid 100018 对乙酰氨基酚Paracetamol 100021 泛影酸Diatrizoic Acid 100022 甘罗溴铵Glycopyrrone Bromide 100023 谷氨酸Glutamic Acid 100024 磺胺Sulfanilamide 100025 磺胺甲恶唑Sulfamethoxazole 100026 磺胺嘧啶Sulfadiazine 100027 黄体酮Progesterone 100028 炔诺孕酮Norgestrel 100029 甲萘醌Menadione 100030 甲巯咪唑Thiamazole 100031 甲氧苄啶Trimethoprim 100032 己酸羟孕酮Hydroxyprogesterone Caproate 100033 己烯雌酚Diethylstilbestrol 100034 枸橼酸氯米芬Clomifene Citrate 100035 甲磺酸双氢麦角毒碱Co-dergocrine Mesylate 100037 克霉唑Clotrimazole 100038 邻甲苯磺酰胺O-Tolylsulfonilamide 100039 6-巯基嘌呤Mercaptopurine 100040 硫酸阿托品毒Atropine Sulfate 100041 利血平Reserpine 100042 2-氯-4-硝基苯胺2-Chloro-4-Nitroaniline 100043 氯普噻吨Chlorprothixene 100045 咪唑Imidazole 100046 吡喹酮Praziquantel 100047 马来酸氯苯那敏Chlorphenamine Maleate 100049 氢溴酸东莨菪碱毒Anisodamine Hydrobromide 100050 氢溴酸加兰他敏Galanthamine Hydrobromide 100052 炔雌醇Ethinylestradiol 100053 炔诺酮Norethisterone 100054 4-N-去甲基安乃近4-N-Demethylanalgin100055 曲安萘德Triamcinolone Acetonide100056 去乙酰毛花甙毒Deslanoside100058 乳糖Lactose100060 酞丁安Ftibamzone100061 维生素D3 Cholecalciferol100062 维生素E RRR-Alpha-Tocopheryl Acetate100063 戊酸雌二醇Estradiol Valerate100065 盐酸胺碘酮Amiodarone Hydrochloride100066 盐酸苯海拉明Diphenhydramine Hydrochloride100067 盐酸苯海索BenzhexolHydrochloride100068 盐酸多沙普仑Doxapram Hydrochloride100069 盐酸多塞平Doxepin Hydrochloride100070 盐酸多巴胺Dopamine Hydrochloride100071 盐酸可乐定Clonidine Hydrochloride100072 盐酸克仑特罗ClenbuterolHydrochloride100073 盐酸芬氟拉明Fenfluramine Hydrochlordie100075 荧光母素Fluorane100076 左炔诺孕酮Levonorgestrel100077 胆红素Bilirubin100078 胆酸Cholic Acid100080 芦丁Rutin100082 葡萄糖酸钙Calcium Gluconate100083 匹莫林Pemoline100084 酒石酸美托洛尔Metoprolol Tartrate100085 氟哌利多Droperidol100086 硝基呋喃丙烯酸5-Nitro-2-Furan-acrylic Acid100088 克罗米通Crotamitone100089 双羟萘酸噻嘧啶Pyrantel Pamoate100090 双羟萘酸Pamoic Acid100091 酚酞Phenolphthalein100093 香草醛Vanillin100094 乙酰苯胺Acetanilide100095 非那西丁Phenacetin100096 磺胺Sulfanilamide100097 茴香酸Anisic acid100098 磺胺二甲嘧啶Sulfamethoxazole100099 双氰胺Dicyanodiamide100100 糖精Glucide100101 咖啡因Caffeine100102 酚酞Phenolphthalein100103 水杨酸片Salicylic Aicd Tablets100105 氨基己酸Aminocaproic Acid100106 水杨酸Salicylic Aicd100107 溴甲阿托品Atropine Methobromide100109 α-甲基吡啶2－Methylpyridine100110 甲磺酸酚妥拉明Phentolamine Mesylate100111 盐酸萘甲唑林Naphazoline Hydrochloride100113 阿司匹林Acetylsalicylic Acid100114 氨苯砜Dapsone100115 烟酰胺Nicotinamide100116 盐酸吡哆辛Pyridoxine Hydrochloride100117 阿替洛尔Atenolol100118 倍他米松Betamethasone100119 丙酸倍氯米松Beclometasone Dipropionate100121 茶碱Theophylline100122 醋酸地塞米松Dexamethasone Acetate100123 醋酸可的松Cortisone Acetate100124 醋酸泼尼松龙Prednisolone Acetate100125 醋酸曲安奈德Triamcinolone Acetonide Acetate100126 达那唑Danazol100127 胆石酸Lithocholic Acid100128 地蒽酚Dithranol100129 地塞米松Dexamethasone100130 丁溴东莨菪碱Scopolamine Butylbromide100131 对甲苯磺酰胺P-Tolysulfonilamide100132 对羟基苯乙酰胺P-Hydroxyphenylacetamide100133 奋乃静Perphenazine100134 酚磺乙胺Etamsylate100135 格列本脲Glibenclamide100136 10％A晶型甲苯咪唑Mebendazole Contain 10％of Polymorph A100138 甲氨蝶呤Methotrexate100139 甲苯咪唑Mebendazole100140 6-甲氧基-2-萘乙酮6-Methoxy-2-acetonaphthone100141 N-甲基哌嗪1-Methylpiperazini100142 卡马西平Carbamazepine100143 硫喷妥Thiopental100144 磷酸咯萘啶Malaridine Phosphate100145 苯丙氨酯Phenprobamate100146 哈西奈德Halcinonide100147 氯化胆碱Choline Chloride100148 氯化琥珀胆碱Suxamethonium Chloride100149 4-2-（5-氯-2-甲氧基苯4－2-5-chloro-2-methoxy- 甲酰胺）-乙基-苯磺酰胺benzamidoethylbenzenesulfonam ide100150 4-2-（5-氯-2-甲氧基苯4－2-5-chloro-2-methoxy- 甲酰胺）-乙基-苯磺酰胺benzamidoethylbenzenesulfonyl 基-甲酸乙酯-N-methyl carbamate100151 吡哌酸Pipemidic Acid100152 氢化可的松Hydrocortisone100153 泼尼松龙Prednisolone100154 肾上腺素Adrenaline100155 维生素D2 Ergocalciferol100156 维生素K1 Phytomenadione100157 硝酸毛果芸香碱（毒）Pilocarpine Nitrate100158 西咪替丁Cimetidine100160 盐酸丙咪嗪Imipramine Hydrochloride100161 盐酸地尔硫Diltiazem Hydrochloride100163 盐酸雷尼替丁Ranitidine Hydrochloride100165 盐酸乙胺丁醇Ethambutol Hydrochloride100167 盐酸左旋咪唑Levamisole Hydrochloride100168 盐酸奈福泮Nefopam Hydrochloride100169 重酒石酸去甲肾上腺素NorepinephrineBitartrate100170 左旋多巴Levodopa100171 醋酸甲地孕酮MegestrolAcetate100172 甲睾酮Methyltestosterone100173 布美他尼Bumetanide100174 氨甲环酸Tranexamic Acid100175 胡椒乙腈Homopiperonylonitrile100176 丙谷胺Proglumide100177 吡罗昔康Piroxicam100179 布洛芬Ibuprofen100180 倍他米松磷酸钠Betamethasone Sodium Phosphate100181 比沙可啶Bisacodyl100182 雌二醇Estradiol100183 醋酸氯己定Chlorhexidine Acetate100184 双氢青蒿素Dihydroartemisinin100185 莪术醇Curcumenol100186 26-二甲基酚26-Dimethylphenol100188 环戊噻嗪Cyclopenthiazide100189 甲基多巴Methyldopa100190 甲芬那酸Mefenamic Acid100191 甲硝唑Metronidazole100192 联苯双酯Bifendate100193 螺内酯Spironolactone100194 碘化钾Potassium Iodide100195 氯噻酮Chlortalidone100196 邻位甲酚O-Cresol100197 硫唑嘌呤Bumetanide100198 萘普生Naproxen100199 泼尼松Prednisone100200 青蒿琥酯Artesunate100201 氢溴酸右美沙芬Dextromethorphane Hydrobromide100203 舒必利Sulpirid100204 沙丁胺醇Salbutamol100206 双氰胺Dicyandiamide100208 水杨酸镁Magnesium Salicylate100209 司坦唑醇Stanozolol100211 辛可尼丁Cinchonidine100212 溴甲贝那替嗪Methylbenactyzii Bromide100213 硝酸咪康唑MiconazoleNitrate100214 硝酸益康唑Econazole Nitrate100216 盐酸安他唑啉Antazoline Hydrochloride100217 盐酸苯丙醇胺Phenylpropanolamine Hydrochlordie100218 盐酸美西律Mexiletine Hydrochloride100219 盐酸酚苄明Phenoxybenzamine Hydrochloride100220 盐酸氯丙那林Clorprenaline Hydrochloride100221 氢醌Hydropuinone100222 盐酸罗通定Rotundine hydrochloride100223 盐酸维拉帕米Verapamil Hydrochloride100224 异维A酸Isotretinoin100225 贝诺酯Benorilate100226 半乳糖Galactose100228 醋酸甲萘氢醌Menadiol Acetate100229 富马酸氯马斯汀Clemastine Fumarate100230 富马酸酮替芬Ketotifen Fumarate100231 果糖Fructose100232 环吡酮胺Ciclopirox Olamine100233 环己胺Cyclohexylamine100235 己内酰胺Hexanolactam100236 硝酸甘油Glyeryl Trinitrate100237 磷酸苯丙哌啉Benproperine Phosphate100238 米诺地尔Minoxidil100241 羟甲香豆素Hymecromone100244 双嘧达莫Dipyridamole100246 羧甲司坦Carbocisteine100247 鱼腥草素钠Sodium Houttuyfonate100248 维生素B12 Cyanocobalamin VitaminB12100249 消旋山莨菪碱Raceanisodamine100250 硝酸异山梨酯Isosorbide Dinitrate100251 月桂氮卓酮Laurocapram100253 盐酸羟甲唑啉Calcium Folinate100257 吲达帕胺Indapamide100258 吲哚美辛Indometacin100259 依他尼酸Etacrynic Acid100260盐酸马普替林Maprotiline Hydrochloride100261 盐酸去氧肾上腺素Phenylephrine Hydrochloride100262 盐酸去氯羟嗪Decloxizine100263 盐酸肼屈嗪Hydralazine Hydrochloride100265 盐酸倍他司汀Betahistine Hydrochloride100266 盐酸羟嗪Hydroxyzine Hydrochloride100267 贝斯素/100269 格列齐特Gliclazide100270 尼莫地平Nimodipine100271 蒿甲醚Artemether100272 金诺芬Auranofin100273 硫酸特布他林Terbutaline Sulfate100274 脱水山梨醇三油酸酯SorbitanTrioleate100275 盐酸丙卡特罗Procaterol Hydrochloride100276 氨鲁米特Aminoglutethimide100277 大豆油Soybean Oil100278 对羟基苯甲酸甲酯Methyl Hydroxybenzoate100279 泛酸钠Sodium Pantothenate100280 格列喹酮Gliquidone100281 格列吡嗪Glipizide100282 4-2-5-甲基吡嗪-2-甲酰4-2-5-methylpyrazin-2- 氨基）乙基〕苯磺酰胺carboxamidoethylbenzenesulpho namide100283 核黄素磷酸钠Riboflavin Sodium Phosphate100284 吉非罗齐Gemfibrozil100288 尿素 Carbarsone100289 氢溴酸高乌甲素Lappaconite Hydrobromide100290 乳酸依沙吖啶Ethacridine Lactate100291 生物素Biotin100292 特非那定Terfenadine100294 酮康唑Ketoconazole100296 维生素C钠Sodium Ascorbate100297 硝酸硫胺Thi amine Nitrate100298 α-细辛脑α－Asarone100299 盐酸二氧丙嗪Dioxopromethazine Hydrochloride100300 盐酸洛哌丁胺Loperamide Hydrochloride100301 阿司咪唑Astemizole100302 丙酸氯倍他索Clobetasol Propionate100303 丁酸氢化可的松Hydrocortisone Butyrate100304 多潘立酮Domperidone100305 法莫替丁Famotidine100306 枸椽酸氯已定Chlorhexidine Citrate100307 维A酸Tretinoin100308 亚硒酸钠SodiumSelenite100309 氢氯噻嗪Hydrochlorothiazide100310 盐酸阿米洛利Amiloride Hydrochloride100311 3，5-二氨基-6-氯吡嗪-2- Methyl 35-diamino-6- 羧酸甲酯chloropyrazine-2-carboxylate100312 苯噻啶Pizotifen100313 氟哌啶醇Haloperidol100314 氟康唑Fluconazole100315 氟胞嘧啶flucytosine100316 枸椽酸他莫昔芬E-异构体Tamoxifen Citrate E－isomer100317 倍他环糊精Betacyclodextin100318 卡托普利.。
什么是基因毒性杂质对于基因毒性杂质的定义主要是指：在以DNA 反应物质为主要研究对象的体内/ 体外试验中，如果发现它们对DNA 有潜在的破坏性，那可称之为基因毒性。
对没有进行体内实验的情况下，也可以根据关联系做一些相关的体外实验去评估该物质在体内的毒性。
如果没有关联评估的，体外基因毒性物质经常被考虑为假定的体内诱变剂和致癌剂。
GUIDELINE ON THE LIMITS OF GENOTOXIC IMPURITIES （ EMEA/CHMP/QWP/251344/2006 ）基因毒性杂质的风险按照目前的法规来说，（体内）基因毒性物质在任何摄入量水平上对DNA 都有潜在的破坏性，这种破坏可能导致肿瘤的产生。
因此，对于基因毒性致癌物，不能说“不存在明显的阀值，或是任何的摄入水平都具有致癌的风险”。
可接受风险的摄入量对于那些可以与DNA 进行反应的化合物，由于在较低的剂量时机体保护机制可以有效的运行，按照摄入量由高到低所造成的影响进行线性推断是很困难的。
目前，对于一个给定诱变剂，我们很难从实验方面证明它的基因毒性存在一个阀值。
特别是对某些化合物，它们可以与非DNA 靶点进行反应，或一些潜在的突变剂，在与关键靶位结合之前就迅速失去了毒性。
由于缺乏支持基因毒性阀值存在的有力证据，而使得我们很难界定一个安全的服用量。
所以有必要采取一个新观点：确定一个可接受其风险的摄入量。
可接受其风险的摄入量即毒理学阈值一般通用的被定义为Threshold of Toxicological Concern （TTC）。
具体含义为：一个“ 1.5ug/day ”的TTC 值，即相当于每天摄入1.5ug 的基因毒性杂质，被认为对于大多数药品来说是可以接受的风险（一生中致癌的风险小于100000 分之1 ）。
按照这个阀值，可以根据预期的每日摄入量计算出活性药物中可接受的杂质水平。
在特定的条件下一些基因毒性杂质也可以有较高的阈值。
相关杂质汇总列表中文名英文名CAS号规格纯度结构式硫辛酸Thioctic Acid1077-28-710mg-20mg-50mg-100mg≥95%硫辛酸杂质1Thioctic Acid Impurity117370-41-110mg-20mg-50mg-100mg≥95%硫辛酸杂质2Thioctic Acid Impurity2N/A10mg-20mg-50mg-100mg≥95%硫辛酸杂质4Thioctic Acid Impurity4462-20-410mg-20mg-50mg-100mg≥95%硫辛酸杂质5Thioctic Acid Impurity5N/A10mg-20mg-50mg-100mg≥95%硫辛酸杂质6Thioctic Acid Impurity61204245-29-310mg-20mg-50mg-100mg≥95%硫辛酸杂质7Thioctic Acid Impurity7108015-78-710mg-20mg-50mg-100mg≥95%硫辛酸杂质8Thioctic Acid Impurity86992-30-910mg-20mg-50mg-100mg≥95%硫辛酸杂质10Thioctic Acid Impurity10N/A10mg-20mg-50mg-100mg≥95%硫辛酸杂质11Thioctic Acid Impurity1125636-58-210mg-20mg-50mg-100mg≥95%硫辛酸杂质12Thioctic Acid Impurity122635383-46-710mg-20mg-50mg-100mg≥95%硫辛酸杂质13Thioctic Acid Impurity13N/A10mg-20mg-50mg-100mg≥95%硫辛酸杂质14Thioctic Acid Impurity141070-64-010mg-20mg-50mg-100mg≥95%硫辛酸杂质15Thioctic Acid Impurity15N/A10mg-20mg-50mg-100mg≥95%硫辛酸杂质16Thioctic Acid Impurity16916746-61-710mg-20mg-50mg-100mg≥95%硫辛酸杂质17Thioctic Acid Impurity17188745-24-610mg-20mg-50mg-100mg≥95%硫辛酸杂质19Thioctic Acid Impurity191200-22-210mg-20mg-50mg-100mg≥95%硫辛酸杂质20Thioctic Acid Impurity20N/A10mg-20mg-50mg-100mg≥95%硫辛酸杂质21Thioctic Acid Impurity2146353-61-110mg-20mg-50mg-100mg≥95%硫辛酸杂质22Thioctic Acid Impurity22940-69-210mg-20mg-50mg-100mg≥95%硫辛酸杂质23Thioctic Acid Impurity23N/A10mg-20mg-50mg-100mg≥95%硫辛酸杂质24Thioctic Acid Impurity24N/A10mg-20mg-50mg-100mg≥95%硫辛酸杂质25Thioctic Acid Impurity2541443-60-110mg-20mg-50mg-100mg≥95%硫辛酸杂质26Thioctic Acid Impurity261070-65-110mg-20mg-50mg-100mg≥95%硫辛酸杂质28Thioctic Acid Impurity2850628-91-610mg-20mg-50mg-100mg≥95%硫辛酸杂质29Thioctic Acid Impurity29N/A10mg-20mg-50mg-100mg≥95%硫辛酸杂质30Thioctic Acid Impurity3090435-60-210mg-20mg-50mg-100mg≥95%硫辛酸杂质31Thioctic Acid Impurity31102939-46-810mg-20mg-50mg-100mg≥95%硫辛酸杂质32Thioctic Acid Impurity3256535-97-810mg-20mg-50mg-100mg≥95%硫辛酸杂质33Thioctic Acid Impurity3374903-53-010mg-20mg-50mg-100mg≥95%硫辛酸杂质34Thioctic Acid Impurity34N/A10mg-20mg-50mg-100mg≥95%硫辛酸杂质35Thioctic Acid Impurity35N/A10mg-20mg-50mg-100mg≥95%硫辛酸杂质37Thioctic Acid Impurity37N/A10mg-20mg-50mg-100mg≥95%硫辛酸杂质38Thioctic Acid Impurity381077-27-610mg-20mg-50mg-100mg≥95%硫辛酸杂质39Thioctic Acid Impurity393884-52-410mg-20mg-50mg-100mg≥95%硫辛酸杂质40Thioctic Acid Impurity406718-96-310mg-20mg-50mg-100mg≥95%硫辛酸杂质41Thioctic Acid Impurity411071-71-210mg-20mg-50mg-100mg≥95%硫辛酸杂质42Thioctic Acid Impurity4250628-92-710mg-20mg-50mg-100mg≥95%硫辛酸杂质43Thioctic Acid Impurity43N/A10mg-20mg-50mg-100mg≥95%硫辛酸杂质44Thioctic Acid Impurity4416662-64-910mg-20mg-50mg-100mg≥95%硫辛酸杂质46Thioctic Acid Impurity46108843-44-310mg-20mg-50mg-100mg≥95%硫辛酸杂质47Thioctic Acid Impurity47N/A10mg-20mg-50mg-100mg≥95%硫辛酸杂质48Thioctic Acid Impurity48N/A10mg-20mg-50mg-100mg≥95%硫辛酸杂质49Thioctic Acid Impurity49N/A10mg-20mg-50mg-100mg≥95%硫辛酸杂质50Thioctic Acid Impurity50116496-52-710mg-20mg-50mg-100mg≥95%硫辛酸杂质51Thioctic Acid Impurity51N/A10mg-20mg-50mg-100mg≥95%硫辛酸杂质52Thioctic Acid Impurity52N/A10mg-20mg-50mg-100mg≥95%硫辛酸杂质53Thioctic Acid Impurity53N/A10mg-20mg-50mg-100mg≥95%硫辛酸杂质55Thioctic Acid Impurity55N/A10mg-20mg-50mg-100mg≥95%硫辛酸杂质56Thioctic Acid Impurity56N/A10mg-20mg-50mg-100mg≥95%硫辛酸杂质57Thioctic Acid Impurity57N/A10mg-20mg-50mg-100mg≥95%硫辛酸杂质58Thioctic Acid Impurity1N/A10mg-20mg-50mg-100mg≥95%硫辛酸杂质59Thioctic Acid Impurity5931565-12-510mg-20mg-50mg-100mg≥95%硫辛酸杂质60Thioctic Acid Impurity6014970-83-310mg-20mg-50mg-100mg≥95%硫辛酸杂质61Thioctic Acid Impurity61N/A10mg-20mg-50mg-100mg≥95%硫辛酸杂质62Thioctic Acid Impurity62N/A10mg-20mg-50mg-100mg≥95%硫辛酸杂质64Thioctic Acid Impurity64N/A10mg-20mg-50mg-100mg≥95%硫辛酸杂质65Thioctic Acid Impurity652114407-83-710mg-20mg-50mg-100mg≥95%硫辛酸杂质66Thioctic Acid Impurity662114407-78-010mg-20mg-50mg-100mg≥95%硫辛酸杂质67Thioctic Acid Impurity672114407-82-610mg-20mg-50mg-100mg≥95%硫辛酸杂质68Thioctic Acid Impurity682114407-76-810mg-20mg-50mg-100mg≥95%硫辛酸杂质69Thioctic Acid Impurity692768625-63-210mg-20mg-50mg-100mg≥95%硫辛酸杂质70Thioctic Acid Impurity702975-17-910mg-20mg-50mg-100mg≥95%硫辛酸杂质71Thioctic Acid Impurity7146236-19-510mg-20mg-50mg-100mg≥95%硫辛酸杂质73Thioctic Acid Impurity73852383-82-510mg-20mg-50mg-100mg≥95%硫辛酸杂质74Thioctic Acid Impurity74947236-49-910mg-20mg-50mg-100mg≥95%硫辛酸杂质75Thioctic Acid Impurity75119365-69-410mg-20mg-50mg-100mg≥95%硫辛酸杂质76Thioctic Acid Impurity7691009-30-210mg-20mg-50mg-100mg≥95%硫辛酸杂质77Thioctic Acid Impurity77872301-12-710mg-20mg-50mg-100mg≥95%1.扬信医药代理各品种杂质对照品:舒更葡糖钠杂质，达托霉素杂质，依维莫司杂质，他克莫司杂质，阿奇霉素杂质，克拉维酸钾杂质，181。
