药用低内毒素系列

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 国, 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 （Sorbitol） suitable 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 grade（benzaldehyde <= 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 acid（glacial）100% 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 国,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

Tris（hydroxymethyl）aminomethane 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

Titanium（IV） 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 test）≤2.5 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 sugar）special 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, noncrystallizing）suitable 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