一、产品介绍
德国默克拥有完备的高品质药用辅料产品线,几乎可提供无菌液体制剂所需的所有主要辅料。其中包括一系列低内毒素产品,对内毒素,微生物进行了严格的控制,并遵循ICHQ3D指南,对元素杂质进行评估与监控。同时积极进行药用辅料的登记备案工作,为医药企业的国内外注册项目提供强有力的支持。下面是默克为中国客户提供的可供注射用的药用辅料产品清单,表中列出的分类是我们根据经验做出的的推荐,实际应用中涉及的辅料可能有更广泛的应用。
二、订货信息
1、保护剂/稳定剂
货号 | 英文名 | 中文名 | 内毒素 | 需氧菌总数 (TAMC) | 霉菌/酵母菌总数 (TYMC) | 备注 |
137096 | D(-)-Mannitol EMPROVE® EXPERT Ph Eur, BP, USP, JP | D-甘露醇 | ≤1 IU/g | ≤100 CFU/g | ≤100 CFU/g | 登记备案号F20180000870(已激活) |
106143 | Meglumine low in endotoxins EMPROVE® API Ph Eur, ChP, JP, USP | 葡甲胺(低内毒素) | ≤1.5 IU/g | N/A | N/A | 登记备案号F20180000400(注射)(已激活)F20180000401(口服)(已激活) |
100892 | Sucrose low in endotoxins EMPROVE® ESSENTIAL Ph Eur, BP, ChP, JP, NF | 蔗糖(低内毒素) | <2 IU/g | ≤500 CFU/g | ≤100 CFU/g | 登记备案号F20170000107(已激活) |
103789 | Sucrose EMPROVE® EXPERT Ph Eur,ChP, JP,NF | 蔗糖(极低内毒素) | <03 IU/g | ≤100 CFU/g | ≤10 CFU/g | 登记备案号F20190000564 |
137004 | Titriplex® III (ethylenedinitrilotetraacetic acid disodium salt dihydrate) EMPROVE® EXPERT Ph Eur,BP,ChP,JP,USP, ACS | 乙二胺四乙酸二钠 (EDTA-2Na) | ≤30 IU/g | ≤100 CFU/g | ≤10 CFU/g | 登记备案号F20190000387(已激活) |
108421 | Titriplex® III (ethylenedinitrilotetraacetic acid disodium salt dihydrate EMPROVE® ESSENTIAL Ph Eur,BP,ChP,JP,USP | 乙二胺四乙酸二钠 (EDTA-2Na) | N/A | N/A | N/A | 登记备案号F20190000386(已激活) |
817081 | Ph Eur,BP,ChP,JP,USPSodium caprylate EMPROVE® EXPERT Ph Eur,ChP,NF | 辛酸钠 | ≤20 IU/g | ≤ 102 CFU/g | ≤101 CFU/g | 登记备案号F20180001635(已激活) |
102776 | Trehalose dihydrate EMPROVE® EXPERT Ph Eur,ChP, NF, JP | 海藻糖 | ≤0.3 IU/g | ≤100 CFU/g | ≤10 CFU/g | 登记备案号F20190000622 |
103669 | Glycine granulated EMPROVE® EXPERT Ph Eur,BP,ChP, JP,USP | 甘氨酸(颗粒) | <2.0 IU/g | ≤10 CFU/g | ≤10 CFU/g | 登记备案号F20200000036 |
100590 | Glycine cryst. EMPROVE® EXPERT Ph Eur,BP,ChP,-JP,USP | 甘氨酸(晶体) | <2.0 IU/g | ≤10 CFU/g | ≤10 CFU/g | 登记备案号F20200000037 |
171597 | Parted® SI 400 LEX (Sorbitol) suitable for use as exdpient EMPROVE® exp Ph Eur,BP,ChP,NF,JP | 山梨醇(低内毒素) | ≤1 IU/g | ≤102 CFU/g | ≤102CFU/g | 登记备案号F20200000177 |
104352 | L-Histidine EMPROVE® EXPERT Ph Eur,ChP,USP,JP | L-组氨酸 | ≤2.0 IU/g | ≤100 CFU/g | ≤100 CFU/g | 登记备案号F20200000384 |
104354 | L-Histidine monohydrochloride monohydrate EMPROVE® EXPERT Ph Eur,BP,ChP,JP | L-组氨酸盐酸盐(一水) | ≤20 IU/g | ≤100 CFU/g | ≤10 CFU/g | 登记备案号F20200000399 |
101544 | L-Arginine monohydrochloride EMPROVE® EXPERT Ph Eur,BP,ChP,JP,USP | L-精氨酸盐酸盐 | ≤3.0 IU/g | ≤100 CFU/g | ≤10 CFU/g | 登记备案号F20200000340 |
101587 | L-Arginine WPROVE® EXPERT Ph Eur,ChP,JP,USP | L-精氨酸 | 2.0 IU/g | ≤100 CFU/g | ≤10 CFU/g | 登记备案号F20210000066 |
108346 | D(+)-Gucose monohydrate EMPROVE® EXPERT Ph Eur, BP, USP | D-葡萄糖(一水) | ≤2.5 IU/g | ≤100 CFU/g | ≤100 CFU/g | |
112488 | N-Acetyl-DL-tryptophan suitable for biopharmaceutical production EMPROVE® bio Ph Eur, BP | D-葡萄糖(一水) | ≤50IU/g | ≤ lOOCFU/g | ≤10 CFU/g | |
137112 | Poloxamer 188 EMPROVE® EXPERT (stabilized with 70ppm BHT) Ph Eur, NF | N-乙酰-DL-色氨酸 | ≤2.5IU/g | ≤10CFU/g | ≤10 CFU/g | |
105321 | D(-)-Fructose EMPROVE® ESSENTIAL Ph Eur, BP, USP, FCC | 泊洛沙姆 | N/A | N/A | N/A | |
817001 | Polyethylene glycol 200 EMPROVE® ESSENTIAL DAB 8 | 果糖 | N/A | N/A | N/A | |
817002 | Polyethylene glycol 300 EMPROVE® ESSENTIAL Ph Eur | 聚乙二醇200 | N/A | N/A | N/A | |
817019 | Polyethylene glycol 3000 EMPROVffiESSENTIALPh | 聚乙二醇300 | N/A | N/A | N/A | |
817006 | Eur Polyethylene glycol 4000 (powder) EM PROVE | 聚乙二醇3000 | N/A | N/A | N/A | |
100002 | ESSENTIAL PhEur Tri-rv^utyl phosphate EMPROVE®EXPERTPh Eur | 磷 聚乙二醇4000 | ≤10IU/ml | ≤100 CFU/g | ≤10 CFU/g | |
108486 | Urea cryst EMPROVE® ESSENTIAL Ph EurzBPz | N/A | N/A | N/A | ||
137030 | Urea cryst. EMPROVE EXPERT Ph Eur, BP, JP, USP, ACS | 酸三丁酯 尿素(晶体) | ≤3.00 lU/g | ≤100 CFU/g | ≤10 CFU/g |
2、溶剂
货号 | 英文名 | 中文名 | 内毒素 | 需氧菌总数 (TAMC) | 霉菌/酵母菌总数 (TYMC) | 备注 |
100967 | Ethanol96%EMPROVE®EXPERTPhEur,ChP/JP/USP | 96%乙醇 | <2.5I.U./ml | <100CFU/ml | <10CFU/ml | 登记备案号 F20200000375 |
100986 | Ethanol absolute EMPROVE® EXPERT PhEur,BP,ChP,JP,USP | 无水乙醇 | <2.5I.U./ml | <100CFU/ml | <10CFU/ml | 登记备案号 F20200000378 |
100971 | Ethanol 96% EMPROVE® EXPERT Ph Eur,BP,ChP | 96%乙醇 | ≤2.5 IU/ml | ≤100 CFU/ml | ≤10 CFU/ml | 根据药典定义与登 |
107478 | 1,2-Propanediol EMPROVE® ESSENTIAL Ph Eur,BP,USP | 1,2-丙二醇 | <2.5IU/ml | <100CFU/g | <50CFU/g | |
137117 | Dimethy lSulfoxide EMPROVE®EXPERT Ph Eur,USP | 二甲亚碰 | <HU/ml | <100CFU/ml | <10CFU/g | |
106049 | Dichloromethane EMPROVE® ESSENTIALPhEur,BP,NF | 二氯甲烷 | N/A | N/A | N/A | |
137028 | Glycerol anhydrous EMPROVE®EXPERT ph Eur,BPJP,USP,ACS | 甘油 | <2.5IU/ml | <102CRJ/ml | <101CRJ/ml | |
104091 | Glycerol 85 % suitable for use as excipient EMPROVE®exp Ph Eur, BP | 甘油(85%) | <2.5IU/ml | <102CRJ/ml | <101CRJ/ml | |
106008 | Methanol EMPROVERESSEhTTIAL Ph Eur,BP,PE,NF | 甲醇 | N/A | N/A | N/A | |
817003 | Polyethylene glycol 400 EMPROVE® ESSENTIAL 改 Eur,JP | 聚乙二醇400 | N/A | N/A | N/A | |
102431 | Chloroform EMPROVE RESSENTIAL | 氯仿 | N/A | N/A | N/A | |
18153 | Tert-butyl Alcohol Special Grade | 叔TB | <2.5IU/ml | <102CFU/g | <101CFU/g | |
137136 | Tetrahyd-ofuranEMPROVE®ESSENTIAL | 堕嚇南 | <25IU/g | <200CFU/g | <200CFU/g | |
100864 | Ethyl acetate EMPROVE® ESSENTIAL Ph EurzBPzNF | 乙酸乙酯 | N/A | N/A | N/A | |
100995 | 2-Propanol EMPROVE® ESSENTIAL Ph EurzBPzJPzUS | 异丙醇 | N/A | N/A | N/A | |
137138 | n-Heptane EMPROVE® Essential | 皿烷 | < 25 lU/g | < 200 CFU/g | < 200 CFU/g |
3、pH调节剂
货号 | 英文名 | 中文名 | 内毒素 | 需氧菌总数 (TAMC) | 霉菌/酵母菌总数 (TYMC) | 备注 |
108386 | T risfhyd roxymethyl)aminomethane(T rometamol) EM PROVE® ESSENTIAL Ph Eur,BP,ChPJPC,USP | MTHSKTris) | <0.03IU/mg | <100CFU/g | <100CFU/g | 登记备案号 F20170000101(已激活) |
100681 | Succinic acid cryst., EMPROVE® ESSENTIAL ChP,NF,JPE,ACS | 嘛白酸(融) | N/A | N/A | N/A | 登记备案号 F20200000380 |
100802 | L(+)-Tartaricacidcryst.,EMPROVE® ESSENTIAL Ph Eur, BP,JP,NF,E334 | L(+)酒碰(融) | N/A | N/A | N/A | 根据国家药监局2019 |
100366 | ⑸-Lacticadd about%% EMPROVE® EXPERT 也 Eur,BP,E270 | S•乳酸(90% ) | <5IU/g | < 100 CFU/ml | < 100 CFU/ml | |
106522 | Sodium-(S)-lactate-solution about 50 % EMPROVE® EXPERTPhEur,BP,USP | S-乳酸钠溶液(50% ) <5 IU/g | <100 CFU/ml | <10CFU/ml | ||
480905 | Ammonia solution 16 % EMPROVE® EXPERT | 氨水(10% ) | <2.5 IU/ml | N/A | N/A | |
100130 | Benzoicadd powder,EMPROVE® ESSENTIALPh Eur,BP,USP,E210 | 苯甲酸(粉末) | N/A | N/A | N/A | |
100056 | Aceticadd(glacial)100% EMPROVE® ESSENTIAL PhEur,BPJP,USP,E260 | 媼酸 | N/A | N/A | N/A | |
100058 | Acetic acid 96% EMPROVER ESSENTIAL | 96%醋酸 | N/A | N/A | N/A | |
100314 | Hydrochloric acid fuming 37% EM PROVE® ESSENTIAL Ph Eur,BP,JP,NF | 发烟盐酸(37% ) | N/A | N/A | N/A | |
100090 | Adipicacid EMPROVE® ESSENTIAL Ph Eur,NF,FCC,E355 | 氏酸 | N/A | N/A | N/A | |
100563 | ortho-Phosphoric acid 85 % EMPROVE® ESSENTIAL Ph Eur, BP, JPE, NF, E 338 | 磷酸(85% ) | N/A | N/A | N/A | |
137039 | Potassium di hydrogen phosphate cryst. EMPROVE® EXPERT Ph Eur, BP, JPC, NF | 磷酸二氢钾(晶体) | <2.5 IU/g | <100 CFU/g | <100CFU/g | |
104871 | Potassium dihydrogen phosphate cryst., EMPROVE ©ESSENTIAL Ph Eur, BP, JPC, NF, E 340 | 磷酸二氢钾(晶体) | N/A | N/A | N/A | |
106345 | Sodium dihydrogen phosphate dihydrate EMPROVER® ESSENTIAL gfxEur,BP,USP,JPE,E 339 | 磷酸二氢钠(二水) | N/A | N/A | N/A | |
137018 | Sodium dihydrogen phosphate dihydrate EMPROVE® EXPERTPhEur,BP,USP,JPE | 磷酸二氢钠(二水) | <2.5 IU/g | <100 CFU/g | <100CFU/g | |
106349 | Sodium dihydrogen phosphate monohvdrate EMPROVER® ESSENTIALBP,USP | 磷酸二氢钠(一水) | <2.5 IU/g | N/A | N/A | |
137093 | Sodium dihydrogen phosphate monohydrate | 磷酸二氢钠(一水) | <2.5 IU/g | <100 CFU/g | <100CFU/g | |
137010 | di-Potassium hydrogen phosphate anhydrous EMPROVE® EXPERTPhEur,BP,USP | 磷隘二钾(无水) | <2.5 IU/g | <100 CFU/g | <100CFU/g | |
105101 | di-Potassium hydrogen phosphate anhydrous EMPROVER® ESSENTIALPh Eur, BP,E 340 | 磷赠二钾(无水) | N/A | N/A | N/A | |
109828 | di-Potassium hydrogen phosphate an hydrous, low in sodium EMPROVE® APIPhEur,BP,USP | 磷酸氢二钠(二水) | <1.1 IU/mg | <500 CFU/g | N/A | |
106576 | di-Sodium hydrogen phosphate dihvdrate EMPROVER®ESSENTIALPhEur,BP,USP | 磷酸氢二钠(二水) | N/A | N/A | N/A | |
137036 | di-Sodium hydrogen phosphate dihydrate EMPROVE®EXPERTPhEur,BP,USP | 磷酸氢二钠(二水)<2.5IU/g | <100 CFU/g | <100 CFU/g | ||
106574 | di-Sodium hydrogen phosphate heptahydrate EMPROVER® ESSENTIAL DAC, USP | 磷酸氢二钠(二水) | N/A | N/A | N/A |
4、pH调节剂(续)
货号 | 英文名 | 中文名 | 内毒素 | 需氧菌总数 (TAMC) | 霉菌/酵母菌总数 (TYMC) | 备注 |
137092 | di-Sodium hydrogen phosphate heptahydrate EM PROVE EXPERT DAC, USP | 磷酸氢二钠(七水) | <2.5IU/g | <100CFU/g | <100 CFU/g | 根据国家药监局 |
106573 | di-Sodium hydrogen phosphate dodecahydrate cryst. EMPROVffiESSENTIAL Ph Eur,BP,ChP,JP,USP | 磷酸氢二钠(十二水) | N/A | N/A | N/A | |
106585 | di-Sodium hydrogen phosphate anhydrous EMPROVER®ESSENTIAL Ph Eur, BP, USP, E 339 | 磷酸氢二钠(无水) | N/A | N/A | N/A | |
100713 | Sulfuric add 95-98 % EMPROVE® ESSENTIAL Ph Eur,BP,JPE,NF | 硫酸(95%-98% ) | N/A | N/A | N/A | |
817058 | Maleic add EMPROVE® ESSENTIAL Ph Eur, NF | 马来 | N/A | N/A | N/A | |
137002 | Citric acid anhydrous powder EMPROVE® EXPERT Ph Eur, BP, JP, USP, ACS | 枸椽酸(无水,粉末) | <10IU/g | <100 CFU/g | <100 CFU/g | |
137003 | Citric acid monohydrate cryst. EMPROVffi EXPERT Ph Eur, BP, JP, USP, ACS | 枸椽酸(—水,晶体) | <10IU/g | <100 CFU/g | <100 CFU/g | |
100242 | Citric acid monohydrate cryst. EMPROVE® ESSENTIAL Ph Eur,BP,ChP广 JP,USP,E 330,FCC | 枸椽酸(一水,晶体) | <0.5 lU/mg | N/A | N/A | |
100243 |
| 枸椽酸(一水,粉末) | <0.5 lU/mg | N/A | N/A | |
106431 | tri-Sodium citrate 5,5-hydrate EMPROVEg ESSENTIAL FU VIII, E 331 | 枸椽酸三钠(5,5水合 物) | N/A | N/A | N/A | |
106432 |
| 枸椽酸三钠(二水,晶体) | N/A | N/A | N/A | |
137042 | tri-Sodium citrate dihydrate cryst. EMPROVE EX-PERT Ph Eur, BP, JP, USP, ACS | 枸椽酸三钠(二水,晶 | <2.5IU/g | <100 CFU/g | <100 CFU/g | |
111037 |
| 枸椽酸三钠(无水) | N/A | N/A | N/A | |
100162 | Boric acid powder, EMPROVE® ESSENTIAL Ph Eur,BP,NF | 硼酸(粉末) | N/A | N/A | N/A | |
100156 | Boricacid cryst, EMPROVE ESSENTIALPh Eur, BP, JP,NF | N/A | N/A | N/A | ||
100160 | Boric acid cryst., EMPROVE® ESSENTIAL Ph Eur,BP,NF | 硼酸(晶体) | N/A | N/A | N/A | |
100164 | Boricacid cryst. EMPROVE®API Ph Eur, BP, NF | 硼酸(晶体) | N/A | N/A | N/A | |
105032 | Potassium hydroxide pellets EMPROVE ESSENTIAL Ph Eur, BP, JP, NF, FCC,E 525 | 氢氧化钾(球形) | N/A | N/A | N/A | |
106482 | Sodium hydroxide pellets EMPROVffiESSENTIAL PhEur, BP, FCC, JP, NF, E 524 | 氢氧化钠(球形) | N/A | N/A | N/A | |
100773 | Tannicacid powderEMPROVEESSENTIALPh Eur,JP, USP | N/A | N/A | N/A | ||
106398 | Sodium carbonate anhydrous EMPROVE® ESSENTIALPh Eur,BP,ChP,JP,NF | 粉末) | N/A | N/A | N/A | |
106386 | Sodium carbonate monohydrate EMPROVE | 碳酸钠(无水) | N/A | N/A | N/A | |
106323 | ESSENTIAL Ph Eur,BP,JP,USP,FCC,E 500 | 碳酸钠(—水) | N/A | N/A | N/A | |
137044 | ESSENTIAL Ph Eur,BP,JP,USP,FCC,E 500Ethanolamine EMPROVE® EXPERT BP,NF | 碳酸氢钠 | ≤2.5 IU/ml | ≤ 102 CFU/ml | ≤ 101 CFU/ml | |
100844 | Ethanolamine EM PROVE® Essential BP, NF | 乙醇铵 | N/A | N/A | N/A | |
137046 | Sodium acetate anhydrous EMPROVE® EXPERT USP | 乙醇铵 | ≤2.5 IU/g | ≤100 CFU/g | ≤100 CFU/g |
5、矿物盐无机盐
货号 | 英文名 | 中文名 | 内毒素 | 需氧菌总数 (TAMC) | 霉菌/酵母菌总数 (TYMC) | 备注 |
108800 | Zinc acetate dihydrate EMPROVffiESSENTIAL Ph Eur, USP | 醋酸锌(二水) | N/A | N/A | N/A | 登记备案号 F20190000157 |
108915 | Zinc chloride Ph Eur,BP,USP | 氯化锌 | N/A | N/A | N/A | 登记备案号 F2019000538 |
137017 | Sodium chlorideEMPROVE®EXPERTPh Eur,BP,ChP广 JP,USP | 氯化钠 | <2.5IU/g | <100 CFU/g | <100 CFU/g | 登记备案号 F20200000063 |
128218 | Ammonium sulfate EMPROVE® EXPERT ACS,NF,ChP | 硫酸铵 | <2.5IU/g | <1000CFU/g | <10 CFU/g | 登记备案号 F20200000042 |
108846 | ZincoxideEMPROVE®ESSENTIALPhEur,BP,ChP,JP,USP | 氧化锌 | N/A | N/A | N/A | 登记备案号 F20200000381 |
128205 | Sodium acetate trihydrate EMPROVE® EXPERT Ph Eur,BP,、0RJP,USP | 醋酸钠(三水) | N/A | N/A | N/A | 登记备案号 F20200000498 |
106520 | Sodium iodide EMPROVBS) ESSENTIALPhEur, BP, JP, USP | 碘化钠 | N/A | N/A | N/A | 根据国家药监局2019 |
101816 | Ammonium sulfate EMPROVE® EXPERTACS, NF | 硫酸铉 | <2.5IU/g | <1000 CFU/g | <10 CFU/g | |
101042 | Aluminium potassium sulfate dodeca hydrate EMPROVE® ESSENTIAL Ph Eu「,BP,USP | 硫酸铝钾(十二水) | N/A | N/A | N/A | |
137182 | Magnesium sulfate hepta hydrate EMPROVEgEXPERT Ph Eur, BP, JP, USP | 硫酸镁(七水) | <1 lU/g | <100 CFU/g | <100 CFU/g | |
106642 | Sodium sulfate deca hydrate cr^st. EMPROVffi ESSENTIAL Ph Eur,BP,JPE,USP | 硫酸钠(十水) | N/A | N/A | N/A | |
137144 | Sodium sulfate anhydrous EMPROV® EXPERTPh Eur, USP, BP | 硫酸钠(无水) | <2.5IU/g | <100 CFU/g | <100 CFU/g | |
106643 | Sodium sulfate anhydrous EMPROVE8ESSENTIAL Ph Eur,BP,USP,E 514 | 硫酸钠(无水) | 根据国家药监局 | |||
106645 | Sodium sulfate anhydrous fine powder EMPROVE® ESSENTIAL Ph Eur,BP,JPE,USP | 硫酸钠(无水,细粉) | N/A | N/A | N/A | |
102792 | Copper(II) sulfate anhydrous EMPROV®ESSENTIAL Ph Eur,BP | 硫酸铜(无水) | N/A | N/A | N/A | |
102788 | Copper(II) sulfate pentahydrate powder EM PROVE® ESSENTIAL Ph Eur,BP,USP | 硫酸铜(五水,粉末) | N/A | N/A | N/A | |
102787 | Copper(II) sulfate penta hydrate cr^st. EM PROVE®-ESSENTIAL Ph Eur,BP,USP | 硫酸铜(五水,晶体) | N/A | N/A | N/A | |
108881 | Zinc sulfate heptahydrate EMPROVffiESSENTIAL Ph Eur,BP,JP,USP,FCC | 硫酸锌(七水) | N/A | N/A | N/A | |
108882 | Zinc sulfate monohydrate EMPROVffiESSENTIAL Ph Eur,USP | 硫酸锌(一水) | N/A | N/A | N/A | |
106577 |
| 磷酸三钠(十二水) | N/A | N/A | N/A | |
142002 | Calcium chloride dihydrate EMPROVE® ESSENTIAL Ph Eur,BP,JP,USP,FCC,E 509 | 氯化钙(二水) | <3.0 IU/g | <100CFU/g | <100 CFU/g | |
137101 | Calcium chloride dihydrate EMPROVE® EXPERT Ph Eur BP IP USP | 氯化钙(二水) | <2.5 IU/g | <100 CFU/g | <100 CFU/g | |
104935 | Potassium chloride EMPROVE® ESSENTIALPh Eur,BP,JP,USP,FCC,E 508 | 氯化钾 | N/A | N/A | N/A | |
137009 | Potassium chloride EMPROVE® EXPERT Ph Eur, BP, USP, JP | 钾 | <2.5 IU/g | <100 CFU/g | <100 CFU/g | |
101084 | Aluminium chloride hexahydrate EMPROVE® ESSENTIAL Ph Eur,BP,USP | 氯化铝(六水) | N/A | N/A | N/A | |
102367 | Magnesium chloride hexahydrate cryst. EM PROVE® API Ph Eur, BP, JPC, USP | 氯化镁(六水,晶体) | <3.0 IU/g | <100 CFU/g | <100 CFU/g | |
105832 | Magnesium chloride hexahydrate cryst. EM PROVE® ESSENTIAL Ph Eur, BP, USP, JPC, FCC, E 511 | 氯化镁(六水,晶体) | 3.0 IU/g | <100 CFU/g | <100 CFU/g | |
137008 | Magnesium chloride hexahydrate cryst. EMPROV® EXPERT Ph Eur, BP, USP, JPC, ACS | 氯化镁(六水,晶体) | <3.0 IU/g | <100 CFU/g | <100 CFU/g | |
106444 | Sodium chloride EMPROVE® API Ph Eur, BP, JP, US | <2.5 IU/g | <100 CFU/g | <100 CFU/g | ||
116224 | Sodium chloride EMPROVE® EXPERT Ph Eur,BP,- JP,USP | 氯化钠 | <2.5IU/g | <100 CFU/g | <10 CFU/g | |
103814 | Iron(III) chloride hexa hydrate EMPROVffi ESSENTIAL Ph EurJPE | 氯化铁(六水) | N/A | N/A | N/A | |
106281 | Sodium acetate anhydrous EMPROVE®ESSENTIAL USP,FCC,E 262 | 醋酸钠(无水) | N/A | N/A | N/A | |
106265 | Sodium acetate extra pure EM PROVE® ESSENTIAL Ph Eur,BP,JP,USP,FCC,E 262 | 醋酸钠(三水) | N/A | N/A | N/A | |
137012 | Sodium acetate trihydrate EM PROVE® EXPERT Ph Eur,BP,JP,USP | 醋酸钠(三水) | <2.5 IU/g | <100 CFU/g | <100 CFU/g | |
137046 | Sodium acetate anhydrous EMPROVE® EXPERT | 醋酸钠(无水) | <2.5 IU/g | <100 CFU/g | <100 CFU/g |
6、抑菌剂与抗氧化剂
货号 | 英文名 | 中文名 | 内毒素 | 需氧菌总数 (TAMC) | 霉菌/酵母菌总数 (TYMC) | 备注 |
100201 | Phenol EMPROVE® ESSENTIAL Ph Eur, JP, USPZ ChP | 苯酚 | N/A | N/A | N/A | 登记备案号 F20170000260(已激活) |
137120 | Benzyl Alcohol EMPROVE® EXPERT Ph Eur,ChP,JP,NF | 苯甲醇 | <2.5EU/ml | <100CFU/ml | <10CFU/ml | 登记备案号 F20180001619(已激活) |
101806 | Benzyl benzoate EMPROVffiESSENTIAL Ph Eur, BP,USP | 苯甲酸苄酯 | N/A | N/A | N/A | 登记备案号 F20200000061 |
100987 | Benzyl alcohol special grade (benzaldehyde <= 0.05%) EMPROVE® EXPERT Ph Eur,BP,JP,NF | 苯甲醇(苯甲醛≤0.05%) | <2.5EU/ml | <102CFU/ml | <101CFU/ml | |
106290 | Sodium benzoate EMPROVffiESSENTIAL Ph Eur, BP, NF, FCC, E 211 | 苯甲酸钠 | N/A | N/A | N/A | |
137123 | Benzalkonium Chloride EMPROVffiEXPERT Ph Eur,NF | <5 IU/mg | N/A | N/A | ||
137124 | Benzalkonium chloride (50% aqueous solution) EMPROVE EXPERT Ph Eur,NF | 苯扎氯铵(50%水溶液) | <2500IU/ml | N/A | N/A | |
817023 | Butylhydroxyanisole E 320 | 香醚(BHA) | N/A | N/A | N/A | |
817074 | Butylhydroxytoluene E321 | 丁基羟基甲苯(BHT) | N/A | N/A | N/A | |
105056 | Potassium disulfite EMPROVE® ESSENTIAL Ph Eur, NF, E 224 | 焦亚硫酸钾 | N/A | N/A | N/A | |
106357 | Sodium disulfite (sodium metabisulfite) EMPROVE® ESSENTIAL Ph Eur, BP, JP, NF, E 223 | 焦亚硫酸钠 | N/A | N/A | N/A | |
106514 | Sodium thiosulfate pentahydrate cryst., EMPROVffi ESSENTIAL Ph Eur, BP, USP | 硫代硫酸钠(五水,晶 体) | N/A | N/A | N/A | |
107427 | Propyl 4-hydroxy|benzoate EMPROVffiESSENTIALPh Eur, BP, JP, NF,FCC | 尼泊金丙酯 | N/A | N/A | N/A | |
106757 | Methyl 4-hydroxy|benzoate EMPROVffiESSENTIAL Ph Eur, BP, JP, NF,FCC | 尼泊金甲酯 | N/A | N/A | N/A | |
106652 | Sodium sulfite EMPROV®SSENTIALPh Eur; BP, NF, E 221 | 亚硫酸钠 | N/A | N/A | N/A |
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