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| 注射（生物疫苗）制剂——药用辅料目录 | |||||
| 序号 | 产品名称 | 英文名称 | CAS号 | 质量标准 | 申报状态 |
| 1 | 蔗糖（供注射用） | Sucrose（for injection） | 57-30-1 | CP/USP/EP | A |
| 2 | 麦芽糖 | Maltose | 6363-53-7 | CP/EP//USP | A |
| 3 | 辛酸钠 | Sodium Caprylate | 1984-06-1 | CP/USP | A |
| 4 | 硫酸铵 | Ammonium Sulfate | 7783-20-2 | CP | A |
| 5 | 硅藻土 | Purified Siliceous Earth | 61790-53-2 | In-House | I |
| 6 | 山梨醇 | Sorbitol | 50-70-4 | CP | I |
| 7 | 磷酸氢二钠十二水合物 | Disodium Hydrogen Phosphate Dodecahydrate | 10039-32-4 | CP/USP/EP | A |
| 8 | 磷酸氢二钠 | Anhydrous Disodium Hydrogen Phosphate | 7558-79-4 | CP/USP/BP/EP | A |
| 9 | 磷酸二氢钠 | Sodium Dihydrogen Phosphate | 10049-21-5 | CP/USP/BP | A |
| 10 | 无水磷酸二氢钠 | Anhydrous Sodium Dihydrogen Phosphate | 7558-80-7 | CP/USP/BP/EP | I |
| 11 | 磷酸二氢钠一水合物 | Sodium Dihydrogen Phosphate Monohydrate | 10049-21-5 | CP/USP/BP | I |
| 12 | 磷酸二氢钠二水合物 | Sodium Dihydrogen Phosphate Dihydrate | 13472-35-0 | CP/USP/BP | I |
| 13 | 无水磷酸氢二钠 | Anhydrous Disodium Hydrogen Phosphate | 7558-79-4 | CP/USP/BP | I |
| 14 | 二水磷酸氢二钠 | Sodium phosphate dibasic dihydrate | 10028-24-7 | USP/BP | I |
| 15 | 七水磷酸氢二钠 | Disodium hosphate heptahydrate | 7782-85-6 | USP/BP | I |
| 16 | 磷酸二氢钾 | Potassium Dihydrogen Phosphate | 7778-77-0 | CP/EP | A |
| 17 | 磷酸氢二钾三水合物 | Dipotassium Hydrogen Phosphate Trihydrate | 16788-57-1 | CP | A |
| 18 | 枸橼酸 | Citric Acid | 5949-29-1 | CP/USP/EP | A |
| 19 | 枸橼酸钠 | Sodium Citrate | 6132-04-3 | CP/USP/EP/JP | A |
| 20 | 碳酸氢钠 | Sodium Bicarbonate | 144-55-8 | CP/EP/JP | A |
| 21 | 无水碳酸钠 | Anhydrous Sodium Carbonate | 497-19-8 | CP/USP/JP | A |
| 22 | 木糖醇（供注射用） | Xylitol（for injection） | 87-99-0 | CP/EP | I |
| 23 | 二甲基亚砜（供注射用） | Dimethyl Sulfoxide（for injection） | 67-68-5 | CP/ USP/EP | I |
| 24 | 氢氧化钾 | Potassium Hydroxide | 1310-58-3 | CP | I |
| 25 | 硫酸镁 | Magnesium Sulfate | 7487-88-9 | CP | I |
| 26 | 硫酸钠 | Sodium Sulfate | 7757-82-6 | CP | I |
| 27 | 硫酸钾 | Potassium Sulfate | 7778-80-5 | In-House | I |
| 28 | 磷酸钠十二水合物 | Tribasic Sodium Phosphate Dodecahydrate | 10101-89-0 | CP | I |
| 29 | 磷酸二氢铵 | Ammonium phosphate Dibasic | 7722-76-1 | In-House | I |
| 30 | 乳糖 | Lactose Monohydrate | 5989-81-1 | CP/USP/EP/JP | A |
| 31 | 果糖 | Fructose | 57-48-7 | CP/USP/EP/JP | A |
| 32 | 甘露醇 | Mannitol | 69-65-8 | CP/USP/EP | A |
| 33 | 硫代硫酸钠 | Sodioum Thiosulfate | 10102-17-7 | CP/USP/EP | A |
| 34 | 二甲基亚砜 | Dimethyl Sulfoxide | 67-68-5 | CP/ USP/EP | A |
| 35 | 丙二醇 | Propylene Glycol | 57-55-6 | CP | A |
| 36 | 甘油 | Glycerol | 56-81-5 | CP/EP/USP | A |
| 37 | 磷酸钙 | Calcium Phosphate Tribasic | 7758-87-4 | CP | 注册中 |
| 38 | 一水合硫酸锰 | Manganese sulphate | 10034-96-5 | In-house | 注册中 |
| 外用药制剂——药用辅料目录 | |||||
| 序号 | 产品名称 | 英文名称 | CAS号 | 质量标准 | 申报状态 |
| 1 | 白凡士林 | White Vaselin | 8009-03-8 | CP/USP/EP | A |
| 2 | 黄凡士林 | Yellow Vaselin | 8009-03-8 | CP/USP/EP | A |
| 3 | 二甲基亚砜 | Dimethyl Sulfoxide | 67-68-5 | CP/ USP/EP | A |
| 4 | 十二烷基硫酸钠 | Sodium Lauryl Sulfate | 151-21-3 | CP/USP/EP | A |
| 5 | 十八醇 | Stearyl Alcohol | 112-92-5 | CP/USP/EP/BP | A |
| 6 | 十六醇 | Cetyl Alcohol | 36653-82-4 | CP/USP/EP/BP | A |
| 7 | 十六十八醇 | Cetostearyl Alcohol | 67762-27-0 | CP/USP/EP | A |
| 8 | 丙二醇 | Propylene Glycol | 57-55-6 | CP | A |
| 9 | 甘油 | Glycerol | 56-81-5 | CP/USP/EP | A |
| 10 | 肉豆蔻酸异丙酯 | Isopropyl Myristate | 110-27-0 | CP/ USP/EP | I |
| 11 | 克罗米通 | crotamiton | 483-63-6 | In-House | I |
| 12 | N-甲基吡咯烷酮 | N-Methylpyrrolidone | 872-50-4 | In-House | I |
| 13 | 硬脂酸 | Stearic Acid | 1957/11/4 | CP/USP/EP/JP | A |
| 14 | 混合脂肪酸甘油酯（硬脂） | Hard Fat | / | CP | A |
| 15 | 聚乙二醇1000 | Polyethylene Glycol 1000 | 25322-68-3 | CP/USP/EP | A |
| 16 | 聚乙二醇1500 | Polyethylene Glycol 1500 | 25322-68-3 | CP/USP/EP/JP | A |
| 17 | 聚乙二醇4000 | Polyethylene Glycol 4000 | 25322-68-3 | CP/JP/USP | A |
| 18 | 聚乙二醇6000 | Polyethylene Glycol 6000 | 25322-68-3 | CP/USP/JP/EP | A |
| 19 | 无水磷酸氢二钠 | Anhydrous Disodium Hydrogen Phosphate | 7558-79-4 | CP/USP/BP/EP | I |
| 20 | 磷酸二氢钾 | Potassium Dihydrogen Phosphate | 7778-77-0 | CP/USP/EP | A |
| 21 | 磷酸氢二钾三水合物 | Dipotassium Hydrogen Phosphate Trihydrate | 16788-57-1 | CP | A |
| 22 | 枸橼酸钠 | Sodium Citrate | 6132-04-3 | CP/USP/EP/JP | A |
| 23 | 无水碳酸钠 | Anhydrous Sodium Carbonate | 497-19-8 | CP/USP/EP/JP | A |
| 24 | 甘露醇 | Mannitol | 69-65-8 | CP/USP | A |
| 25 | 果糖 | Fructose | 57-48-7 | CP/USP/EP/JP | A |
| 26 | 微晶纤维素 | Microcrystalline Cellulose | 9004-34-6 | CP/USP/EP/JP | A |
| 27 | 交联聚维酮 | Crospovidone | 9003-39-8 | CP/ USP/EP | A |
| 28 | 羟丙甲纤维素 | Hypromellose | 9004-65-3 | CP/USP/EP/JP | A |
| 29 | 低取代羟丙纤维素 | Low-Substituted Hydroxypropyl Cellulose | 9004-64-2 | CP | A |
| 口服制剂——药用辅料目录 | |||||
| 序号 | 产品名称 | 英文名称 | CAS号 | 质量标准 | 申报状态 |
| 1 | 微晶纤维素 | Microcrystalline Cellulose | 9004-34-6 | CP/USP/EP/JP | A |
| 2 | 乳糖 | Lactose Monohydrate | 5989-81-1 | CP/USP/EP/JP | A |
| 3 | 无水磷酸氢钙 | Anhydrous Calcium Hydrogen Phosphate | 7757-93-9 | CP/USP | A |
| 4 | 磷酸氢钙二水合物 | Calcium Hydrogen Phosphate Dihydrate | 7789-77-7 | CP | I |
| 5 | 阿司帕坦 | Aspartame | 22839-47-0 | CP/USP/EP | A |
| 6 | 高岭土 | Kaolin | / | In-house | I |
| 7 | 麦芽糖 | Maltose | 6363-53-7 | CP/USP | A |
| 8 | 麦芽糖醇 | Maltitol | 585-88-6 | CP | I |
| 9 | 木糖醇 | Xylitol | 87-99-0 | CP/EP | A |
| 10 | 甘露醇 | Mannitol | 69-65-8 | CP/USP/EP | A |
| 11 | 山梨醇 | Sorbitol | 50-70-4 | CP | I |
| 12 | 十二烷基硫酸钠 | Sodium Lauryl Sulfate | 151-21-3 | CP/USP/EP | A |
| 13 | 羧甲淀粉钠 | Sodium Starch Glycolate | 9063-38-1 | CP/USP/EP/JP | A |
| 14 | 聚维酮K30 | Povidone K30 | 9003-39-8 | CP/USP/EP | A |
| 15 | 交联聚维酮 | Crospovidone | 9003-39-8 | CP/ USP/EP | A |
| 16 | 羧甲纤维素钠 | Carboxymethylcellulose Sodium | 9004-32-4 | CP/USP/EP | A |
| 17 | 交联羧甲纤维素钠 | Croscarmellose Sodium | 74811-65-7 | CP/USP/EP/JP | A |
| 18 | 羟丙甲纤维素 | Hypromellose | 9004-65-3 | CP/JP | A |
| 19 | 二氧化钛 | Titanium Dioxide | 13463-67-7 | CP | A |
| 20 | 二氧化硅 | Silicon Dioxide | 14464-46-1 | CP/USP | A |
| 21 | 麦芽糊精 | Maltodextrin | 9050-36-6 | CP/EP//USP | A |
| 22 | 倍他环糊精 | Betacyclodextrin | 7585-39-9 | CP | A |
| 23 | 预胶化淀粉 | Pregelatinized Starch | 9005-25-8 | CP | A |
| 24 | 硬脂酸镁 | Magnesium Stearate | 557-04-0 | CP/USP/EP/JP | A |
| 25 | 硬脂酸钙 | Calcium Stearate | 1592-23-0 | CP/USP/EP/JP | A |
| 26 | 硫酸镁 | Magnesium Sulfate | 7487-88-9 | CP | I |
| 27 | 枸橼酸 | Citric Acid | 5949-29-1 | CP/USP/EP | A |
| 28 | 枸橼酸钠 | Sodium Citrate | 6132-04-3 | CP/USP/EP/JP | A |
| 29 | 碳酸氢钠 | Sodium Bicarbonate | 144-55-8 | CP/EP/JP | A |
| 30 | 无水碳酸钠 | Anhydrous Sodium Carbonate | 497-19-8 | CP/USP | A |
| 31 | 蔗糖 | Sucrose | 57-50-1 | CP/USP/EP | A |
| 32 | 果糖 | Fructose | 57-48-7 | CP/JP | A |
| 33 | 丙二醇 | Propylene Glycol | 57-55-6 | CP/EP | A |
| 34 | 甘油 | Glycerol | 56-81-5 | CP/EP/USP | A |
| 35 | 聚乙二醇1000 | Polyethylene Glycol 1000 | 25322-68-3 | CP/USP | A |
| 36 | 聚乙二醇1500 | Polyethylene Glycol 1500 | 25322-68-3 | CP/USP/JP | A |
| 37 | 聚乙二醇4000 | Polyethylene Glycol 4000 | 25322-68-3 | CP/JP/USP | A |
| 38 | 聚乙二醇6000 | Polyethylene Glycol 6000 | 25322-68-3 | CP/USP/JP/EP | A |
| 39 | 高岭土 | Kaolin | / | In-house | I |
| 40 | 琥珀酸 | Succinic Acid | 110-15-6 | CP | I |
| 41 | 赤藓糖醇 | Erythritol | 149-32-6 | In-house | I |
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