默克药用低内毒素系列产品的生产工艺、生产环境、包装系统均严格符合高风险制剂的生产和研发要求。该系列产品以极低的内毒素/微生物控制水平以及全球领先的杂质控制技术大大降低了除菌工艺的风险和确保了制剂的长期稳定性。EMPROVE®文件系统,参考 ICH Q9 EU 2015/C95/02 提供风险评估支持,为国际化产品提供法规助力。 

药用低内毒素

货号

品名

中文名

内毒素

TAMC(总菌)

TYMC(霉菌/酵母)

Stabilizer 保护剂

100892

Sucrose low in endotoxins suitable for use as excipient EMPROVE® Essential Ph Eur,BP,JP,NF

蔗糖(低内毒素, JXFL1300025 国)

2.0 I.U./g

500 CFU/g

100 CFU/g

105303

D--Mannitol low in endotoxins, suitable for use as an active pharmaceutical ingredient EMPROVE® api Ph Eur,BP,USP,JP

甘露醇(低内毒素,原料药级,JXHL1300010 , DMF

1 I.U./g

200 CFU/g

100 CFU/g

101587

L-Arginine suitable for use as excipient EMPROVE® Essential Ph Eur,USP

精氨酸(JXFL1300024 国)

2.0 I.U./g

 

 

100320

Potassium Chloride suitable for use as an active pharmaceutical ingredient EMPROVE® api Ph Eur,BP,JP,USP,E 508,FCC

氯化钾(JXFL1200031 国)

5.0 I.U./g

 

 

105832

Magnesium chloride hexahydrate cryst. EMPROVE® Ph Eur,BP,USP,JPC,FCC,E 511

氯化镁(六水,结晶,JXFL1200032 国)

3.0 I.U./g

100 CFU/g

100 CFU/g

100590

Glycine cryst. suitable for use as excipient EMPROVE® Essential Ph.Eur.,BP,JP,USP

甘氨酸

3.0 I.U./g

 

 

111597

Parteck® SI 400 LEX Sorbitolsuitable for use asexcipient EMPROVE® Essential Ph Eur,BP,NF,JP

Parteck® 山梨醇 400(低内毒素)

1 I.U./g

200 CFU/g

100 CFU/g

112488

N-Acetyl-DL-tryptophan suitable for biopharmaceutical production EMPROVE® bio Ph Eur,BP

N- 乙酰-DL- 色氨酸

50 I.U./g

 

 

101700

L-Alanine suitable for use as excipient EMPROVE® EssentialPh Eur,USP

丙氨酸

2.0 I.U./g

 

 

101544

L-Arginine monohydrochloride suitable for use as excipient EMPROVE® Essential Ph Eur,BP,USP

精氨酸盐酸盐

3.0 I.U./g

 

 

104352

L-Histidine suitable for use as excipient EMPROVE® EssentialPh Eur,USP

组氨酸

2.0 I.U./g

 

 

108346

D+-Glucose monohydrate suitable for use as excipient EMPROVE® Essential Ph Eur,BP,USP

葡萄糖(一水)

2.5 I.U./g

1000 CFU/g

100 CFU/g

货号

品名

中文名

内毒素

TAMC(总菌)

TYMC(霉菌/酵母)

Solvent 溶剂

61983225

001730IN

Tert-Butyl alcohol

叔丁醇

0.25 I.U./ml

10 CFU/ 100 ml

10 CFU/100 ml

100971

Ethanol 96% suitable for use as excipient EMPROVE® Essential Ph Eur,BP

乙醇(96%

2.5 I.U./ml

100 CFU/g

10 CFU/g

100987

Benzyl alcohol special gradebenzaldehyde <= 0.05%suitable for use as excipient EMPROVE® Essential Ph Eur,BP,JP,NF

苯甲醇

(苯甲醛_ 0.05%

2.5 I.U./ml

100 CFU/g

10 CFU/g

137000

Acetic acidglacial100% suitable for biopharmaceutical production EMPROVE® bio Ph Eur,BP,JP,USP,ACS

冰醋酸

2.5 I.U./ml

 

 

480905

Ammonia solution 10% suitable for biopharmaceutical production EMPROVE® bio

氨水(10%

2.5 I.U./ml

 

 

货号

品名

中文名

内毒素

TAMC(总菌)

TYMC(霉菌/酵母)

Others 其他

106143

Meglumine low in endotoxins suitable for use as active pharmaceutical ingredient EMPROVE® api Ph Eur,JP,USP

葡甲胺(低内毒素,原料药级, JXHL1300504 ,DMF

LAL-test

1.5 U./g

 

 

100242

Citric acid monohydrate cryst., suitable for use as excipient EMPROVE® Essential Ph Eur,BP,JP,USP,E 330,FCC

柠檬酸(一水,晶体,JXFL1300021 国)

0.5 I.U./mg

 

 

102304

Calcium hydrogen phosphate anhydrous extra fine powder suitable for use as excipient EMPROVE® Essential Ph Eur,BP,JP,USP,FCC,E 341

无水磷酸氢钙

JXFL1200033 国)

 

2000 CFU/g

200 CFU/g

CH2900014

DOTAP-Chloride

2,3- 二油氧基丙基)

三甲基氯化铵

0.40 E.U./mg

100 CFU/g

100 CFU/g

CH2900013

DOPC

1,2- 二油酰基磷脂酰胆碱

 

100 CFU/g

100 CFU/g

141355

Polyvinyl alcohol 18-88 suitable for use as excipient EMPROVE® Essential Ph Eur,USP,JPE

聚乙烯醇18-88

0.03 I.U./mg

1x10²CFU/g

1x10²CFU/g

141352

Polyvinyl alcohol 26-88 suitable for use as excipient EMPROVE® Essential Ph Eur,USP,JPE

聚乙烯醇 26-88

0.03 I.U./mg

1x10²CFU/g

1x10²CFU/g

141356

Polyvinyl alcohol 28-99 suitable for use as excipient EMPROVE® Essential JPE

聚乙烯醇 28-99

0.03 I.U./mg

1x10²CFU/g

1x10²CFU/g

141353

Polyvinyl alcohol 40-88 suitable for use as excipient EMPROVE® Essential Ph Eur,USP,JPE

聚乙烯醇 40-88

0.03 I.U./mg

1x10²CFU/g

1x10²CFU/g

141350

Polyvinyl alcohol 4-88 suitable for use as excipient EMPROVE® Essential Ph Eur,USP,JPE

聚乙烯醇 4-88

0.03 I.U./mg

1x10²CFU/g

1x10²CFU/g

141354

Polyvinyl alcohol 5-88 suitable for use as excipient EMPROVE® Essential Ph Eur,USP,JPE

聚乙烯醇 5-88

0.03 I.U./mg

1x10²CFU/g

1x10²CFU/g

141351

Polyvinyl alcohol 8-88 suitable for use as excipient EMPROVE® Essential Ph Eur,USP,JPE

聚乙烯醇 8-88

0.03 I.U./mg

1x10²CFU/g

1x10²CFU/g

112635

Parteck® Delta M Mannitol suitable for use as excipient EMPROVE® Essential Ph Eur,BP,USP,JP,E 421

Parteck® Delta 甘露醇

JXFL1300013 国)

 

2000 CFU/g

200 CFU/g

100494

Parteck® M 100 Mannitol suitable for use as excipient EMPROVE® Essential Ph Eur,BP,JP,USP,E 421

Parteck® 甘露醇 100

JXFL1300011 国)

 

2000 CFU/g

200 CFU/g

100419

Parteck® M 200 Mannitol suitable for use as excipient EMPROVE® Essential Ph Eur,BP,JP,USP,E 421

Parteck® 甘露醇 200

JXFL1300012 国)

 

2000 CFU/g

200 CFU/g

103583

Parteck® SI 150 Sorbitol suitable for use as excipient EMPROVE® Essential Ph Eur,BP,JP,NF,JSFA,E 420

Parteck® 山梨醇 150

 

500 CFU/g

100 CFU/g

102440

Parteck® Mg DC Magnesium hydroxide carbonate heavy suitable for use as excipient EMPROVE® Essential Ph Eur,BP,USP,E 504

Parteck® 碳酸氢氧镁

(重质)

 

2000 CFU/g

200 CFU/g

100661

Parteck® LUB STA 50 Stearic acid 50 vegetable grade suitable for use as excipient EMPROVE® Essential Ph Eur,BP,JP,NF

Parteck® 硬脂酸

 

1x10³ CFU/g

1x10²CFU/g

100664

Parteck® LUB CST Calcium stearate vegetable grade suitable for use as excipient EMPROVE® Essential Ph Eur,BP,JP,NF,FCC

Parteck® 硬脂酸钙

 

1x10³ CFU/g

1x10²CFU/g

100663

Parteck® LUB MST Magnesium stearate vegetable grade suitable for use as excipient EMPROVE® Essential Ph Eur,BP,JP,NF,FCC

Parteck® 硬脂酸镁

 

1x10³ CFU/g

1x10²CFU/g

108070

PARTECK® LUB Talc suitable for use as excipient EMPROVE® Essential Ph Eur,BP,JP,USP

Parteck® 滑石粉

 

100 CFU/g

50 CFU/g

102148

Calcium D-saccharate suitable for use as excipient EMPROVE® Essential USP

D- 蔗糖酸钙

100 I.U./mg

100 CFU/g

100 CFU/g

106946

Oxynex® LM antioxidant for fats and oils suitable for use as excipient EMPROVE® Essential

Oxynex® LM 抗氧化剂

 

100 CFU/g

100 CFU/g

104228

Gum arabic spray-dried, suitable for use as excipient EMPROVE® Essential Ph Eur,BP

阿拉伯胶(喷雾干燥)

 

1x10³ CFU/g

1x10²CFU/g

108219

Trishydroxymethylaminomethane hydrochloride suitable for biopharmaceutical production EMPROVE® bio

氨丁三醇盐酸盐

2.5 I.U./g

100 CFU/g

 

108386

Tris(hydroxymethyl)aminomethane (Trometamol) suitable for use as excipient EMPROVE® Essential Ph Eur,BP,JPC,USP

氨丁三醇

0.03 I.U./g

100 CFU/g

100 CFU/g

105006

Bole white powder low bacterial content, for internal use, suitable for use as excipient EMPROVE® Essential Ph Eur,BP

白陶土

 

1x10³ CFU/g

1x10²CFU/g

102735

L-Cysteine hydrochloride monohydrate suitable for use as excipient EMPROVE® Essential Ph Eur,USP

半胱氨酸

6.0 I.U./g

 

 

107267

L-Phenylalanine suitable for use as excipient EMPROVE® Essential Ph Eur,USP

苯丙氨酸

3.0 I.U./g

 

 

137012

Sodium acetate trihydrate suitable for the biopharmaceutical production EMPROVE® bio Ph Eur,BP,JP,USP

醋酸钠(三水)

2.5 I.U./g

100 CFU/g

100 CFU/g

137046

Sodium acetate anhydrous suitable for the biopharmaceutical production EMPROVE® bio USP

醋酸钠(无水)

2.5 I.U./g

100 CFU/g

100 CFU/g

101253

Starch soluble extra pure

淀粉(可溶性)

 

5000 CFU/g

500 CFU/g

100805

TitaniumIV oxide suitable for use as excipient EMPROVE® Essential Ph Eur,BP,USP,JP,E 171

二氧化钛

 

100 CFU/g

100 CFU/g

500111

COCARBOXYLASE TETRAHYDRATE ..., SUITABLE FOR USE AS AN ACTIVE PHARMACEUTICAL INGREDIENT EMPROVE API

辅羧酶(四水, ASMF

12 I.U./g

 

 

500112

COCARBOXYLASE CHLORIDE THIAMINE DIPHOSPHORIC ACID ESTER CHLORIDE, SUITABLE FOR USE AS AN ... EMPROVE® API

辅羧酶氯化物(原料药级)

12 I.U./g

500 CFU/g

100 CFU/g

100286

L-Glutamine suitable for use as excipient EMPROVE® Essential DAB,USP

谷氨酸

2.0 I.U./g

 

 

108405

Gum tragacanth with low bacterial count fine powder

黄芪胶(低菌)

 

1000 CFU/g

100 CFU/g

102555

Charcoal activated Ph Eur

活性炭

 

1x10³ CFU/g

1x10²CFU/g

108643

Triton® X-100 suitable for the biopharmaceutical production EMPROVE® bio Ph Eur,NF

聚乙二醇辛基苯基醚

100 I.U./ml

 

 

105701

L-Lysine monohydrochloride suitable for use as excipient EMPROVE® Essential Ph Eur,BP,USP

赖氨酸盐酸盐

3.0 I.U./g

 

 

105020

L-Leucine suitable for use as excipient EMPROVE® Essential Ph Eur,USP

亮氨酸

3.0 I.U./g

 

 

137039

Potassium dihydrogen phosphate cryst. suitable for the biopharmaceutical production EMPROVE® bio Ph Eur,BP,NF

磷酸二氢钾(晶体)

2.5 I.U./g

100 CFU/g

100 CFU/g

137018

Sodium dihydrogen phosphate dihydrate suitable for the biopharmaceutical production EMPROVE® bio Ph Eur,BP,USP,JPE

磷酸二氢钠(二水)

2.5 I.U./g

1x10²CFU/g

1x10²CFU/g

106349

Sodium dihydrogen phosphate monohydrate suitable for use as excipient EMPROVE® Essential BP,USP

磷酸二氢钠(一水)

2.5 I.U./g

 

 

109828

di-Potassium hydrogen phosphate anhydrous,low in sodium suitable for use as an active pharmaceutical ingredient EMPROVE® api Ph Eur,BP,USP

磷酸氢二钾(无水,低钠,原料药级, DMF

1.1 I.U./mg

500 CFU/g

 

137036

di-Sodium hydrogen phosphate dihydrate suitable for the biopharmaceutical production EMPROVE® bio Ph Eur,BP,USP

磷酸氢二钠

2.5 I.U./g

1x10²CFU/g

1x10²CFU/g

480704

Sulfuric acid 10% suitable for biopharmaceutical production EMPROVE® bio

硫酸(10%

2.5 I.U./ml

 

 

101816

Ammonium sulfate suitable for the biopharmaceutical production EMPROVE® bio ACS,NF

硫酸铵

2.5 I.U./g

1000 CFU/g

10 CFU/g

102465

Calcium chloride dihydrate EMPROVE® api Ph Eur,BP,JP,USP

氯化钙(二水,CEP

3.0 I.U./g

100 CFU/g

100 CFU/g

116224

Sodium chloride low in endotoxins suitable for use as excipient EMPROVE® Essential Ph Eur,BP,JP,USP

氯化钠(低内毒素)

kinetic turbidimetric test2.5 I.U./g

 

 

106444

Sodium chloride suitable for use as an active pharmaceutical ingredient EMPROVE® api Ph Eur,BP,JP,USP

氯化钠(原料药级)

2.5 I.U./g

1x10²CFU/g

1x10²CFU/g

137030

Urea cryst. suitable for the biopharmaceutical production EMPROVE® bio Ph Eur,BP,JP,USP,ACS

尿素(晶体)

3.00 I.U./g

1x10²CFU/g

1x10²CFU/g

100241

Citric acid anhydrous powder, suitable for use as excipient EMPROVE® Essential Ph Eur,BP,JP,USP,E 330,FCC

柠檬酸(无水,粉末)

0.5 I.U./mg

 

 

100247

Citric acid anhydrous fine-granular, suitable for use as excipient EMPROVE® Essential Ph Eur,BP,JP,USP,E USP,E 330,FCC

柠檬酸(无水,精细颗粒)

0.5 I.U./mg

 

 

100243

Citric acid monohydrate powder, suitable for use as excipient EMPROVE® Essential Ph Eur,BP,JP,USP,E 330,FCC

柠檬酸(一水,粉末)

0.5 I.U./mg

 

 

102092

tri-Calcium dicitrate tetrahydrate suitable for use as excipient EMPROVE® Essential DAC,USP,E 333,FCC

柠檬酸钙(四水)

 

1000 CFU/g

100 CFU/g

137042

tri-Sodium citrate dihydrate cryst. suitable for the biopharmaceutical production EMPROVE® bio Ph Eur,BP,JP,USP,ACS

柠檬酸钠(二水,晶体)

2.5 I.U./g

100 CFU/g

100 CFU/g

137048

D+-Glucose anhydrous suitable for the biopharmaceutical production Ph Eur,BP,USP

葡萄糖(无水)

2.5 I.U./g

 

 

105870

Magnesium hydroxide extra pure Ph Eur,BP,USP

氢氧化镁

 

2000 CFU/g

200 CFU/g

137020

Sodium hydroxide pellets suitable for the biopharmaceutical production EMPROVE® bio Ph Eur,BP,JP,NF,ACS

氢氧化钠

2.5 I.U./g

 

 

101615

Agar extra pure, fine powder Ph Eur,BP

琼脂

 

1000 CFU/g

100 CFU/g

100366

S-Lactic acid about 90% suitable for use as excipient EMPROVE® Essential Ph Eur,BP,E 270

乳酸

5 I.U./mg

 

 

106522

Sodium-S-lactate-solution about 50% suitable for use as exipient EMPROVE® Essential Ph Eur,BP,USP

乳酸钠溶液(低内毒素)

5 I.U./mg

100 CFU/g

10 CFU/g

108195

Lactose monohydrate milk sugarspecial grade for tabletting, suitable for use as excipient EMPROVE® Essential Ph Eur,BP,NF,JP

乳糖(一水,用于压片)

 

100 CFU/g

50 CFU/g

137022

Triethanolamine Trolamine suitable for biopharmaceutical production EMPROVE® bio Ph Eur,JPE,NF

三乙醇胺

2.5 I.U./ml

 

 

108396

L-Tryptophan suitable for use as excipient EMPROVE® Essential Ph Eur,BP,USP

色氨酸

10 I.U./g

 

 

102975

Sorbitol FP liquid sorbitol syrup, noncrystallizingsuitable for use as excipient EMPROVE® Essential Ph Eur,BP,NF,E 420

山梨醇FP 液体(山梨醇浆,非晶化)

 

1000 CFU/ml

100 CFU/ml

107647

L-Serine suitable for use as excipient EMPROVE® Essential Ph Eur,USP

丝氨酸

2.0 I.U./g

 

 

137014

Sodium carbonate anhydrous, suitable for the biopharmaceutical production EMPROVE® bio Ph Eur,BP,JP,NF

碳酸钠(无水)

2.5 I.U./g

100 CFU/g

100 CFU/g

137013

Sodium hydrogen carbonate suitable for the biopharmaceutical production EMPROVE® bio Ph Eur,BP,USP,JP

碳酸氢钠

2.5 I.U./g

 

 

105829

Magnesium hydroxide carbonate heavy extra pure Ph Eur,BP,USP,E 504

碳酸氢氧镁(重质)

 

2000 CFU/g

200 CFU/g

101565

L-Asparagine monohydrate suitable for use as excipient EMPROVE® Essential Ph Eur

天门冬氨酸

3.0 I.U./g

 

 

500858

VITAMIN E DRY POWDER SUITABLE FOR USE AS EXCIPIENT EMPROVE Essential PH EUR,BP,USP

维生素E 干粉(33%

 

1000 CFU/g

100 CFU/g

500859

VITAMIN E DRY POWDER SUITABLE FOR USE AS EXCIPIENT EMPROVE Essential PH EUR,BP,USP

维生素E 干粉(50%

 

1000 CFU/g

100 CFU/g

500878

VITAMIN E DRY POWDER SPRAYED SUITABLE FOR USE AS EXCIPIENT EMPROVE Essential PH EUR,BP

维生素E 喷雾干粉(50%

 

1000 CFU/g

100 CFU/g

500854

VITAMIN E READY-TO-PRESS GRANULES 33 G ALLRAC- A-TOCOPHERYL ACETATE IN 100 G ... EMPROVE Essential PH EUR,BP

维生素E 直压颗粒(33%

 

1000 CFU/g

100 CFU/g

817081

Sodium caprylate suitable for use as exipient EMPROVE® Essential Ph Eur,NF

辛酸钠

20 I.U./g

 

 

108197

Tabletting aid K cellulose powder Ph Eur, BP, JP, NF, E 460 ii

压片辅料K(纤维素粉)

 

1x10³ CFU/g

1x10²CFU/g

137007

Hydrochloric acid fuming 37% suitable for biopharmaceutical production EMPROVE® bio Ph Eur,BP,JP,NF,ACS

盐酸(37%

2.5 I.U./ml

 

 

137044

Ethanolamine suitable for biopharmaceutical production EMPROVE® bio BP,NF

乙醇胺

2.5 I.U./ml

 

 

142020

Cyclodextrin HPB Ph.Eur., NF

羟丙基贝他环糊精

10 I.U./g

1000 CFU/g

100 CFU/g