We have been producing high purity salts for制药和兽医companies for more than 15 years. Quality Chemicals is a reliable supplier to the world’s largest companies in this sector.

万博博彩manbet优质化学品提供全面的必要药剂组合。这些包括API,中间体,赋形剂,起始材料,溶剂和试剂。

Our dedicated pharma team provides a network of services:

  • Regulatory support
  • 万博客户端登录GMP产品重新包装
  • Change management notification
  • 产品文档
  • Transparent supply chain: lot traceability, supplier audits, suppliers data sharing etc.
  • 从实验室到全部生产
  • Collaborative development; optimised particle size, custom mixtures, etc.
  • Customer audits

我们的两家植物我们的GMP工厂于2004年以来一直在运万博客户端登录营,并符合GMP指南ICH-Q7 - EU-GMP第二部分。它主要为制药,兽医和生物制药行业生产原料。

我们提供our salts mainly for two types of customers:

对于这个组,我们直接提供原材料,通常不会要求GMP等级,而是根据任何药典提出:万博客户端登录

  • PhEur – European Pharmacopeia
  • USP – United States Pharmacopeia
  • NF – National Formulary (US)
  • BP – British Pharmacopeia
  • JP – Japanese Pharmacopeia
  • Chinese Standard Pharmacopeia
  • DAB- Deutsches Arzneibuch (German pharmacopeia)

We also offer multi-compendial products: the product can be supplied in compliance with the quality standards of individual pharmacopoeias, a combination of several of them or even without a monograph in any pharmacopoeia.

For this group we can supply our salts according to different pharmacopeia and also manufactured under GMP, required by law for APIs and recommended for excipients.

Excipient manufacturers in general are not directly covered by EU law. The manufacturer of the medicinal product must ensure excipients and their suppliers are controlled appropriately.

API

所有适用于API的产品都是在GMP条件下生产的,并满足欧洲GMP指南的要求,用于制造药品二极管,活性物质(ICH 万博客户端登录Q7)。

对于API,我们为监管事务提供支持:

  • CEP欧洲药典的适用证证书
  • ASMFActive Substance Master Files

All these documents can be provided ine-CTD format

APIs available:

刺激uct CAS No. Code EU ASMF CEP US DMF
Acetic Acid 80% w/w GMP 64-19-7 384110
氯化铵GMP万博客户端登录 12125-02-9. 350314 R0-CEP 2021-326
Ammonium molybdate 4 hydrate GMP 12054-85-2

386915
Calcium hydrogenphosphate anhydrous GMP 7757-93-9. 383410
Chromium (III) chloride 6-hydrate GMP USP 10125-13-0 388115
Cinc acetate 2-hydrate (parenteral) GMP 5970-45-6 351244 R0-CEP 2018-117-Rev 00
Cinc oxide GMP 1314-13-2 304814
Cobalt (II) chloride 6-hydrate GMP QP 7791-13-1 386010
铜(II)氧化物GMP万博客户端登录 1317-38-0 352702
Copper II sulphate 5-hydrate GMP 7758-99-8 380214
Copper(II) hydroxicarbonate(Malaquita) GMP 12069-69-1 353510
Di-sodium hydrogenphosphate 12-hydrate (parenteral) GMP 10039-32-4 351544 R0-CEP 2017-233-REV 01
L(+)-Tartaric acid GMP 87-69-4 381414
Magnesium acetate 4-hydrate (parenteral) GMP 16674-78-5 353042 R0-CEP 2017-280-Rev 00
Magnesium bromide 6-hydrate GMP QP 16674-78-5 385610
Magnesium fluoride GMP QP 16674-78-5 355510
氢氧化镁GMP.万博客户端登录 1309-42-8 384514
Magnesium L-lactate 2-hydrate GMP 18917-93-6 353414
锰碳酸盐沉淀GMP万博客户端登录 598-62-9 352310
苯酚gmp.万博客户端登录 108-95-2 352610
Potassium acetate (parenteral) GMP 127-08-2 387144 R0-CEP 2018-028-Rev 00
Potassium bromide GMP 7758-02-3 351814
溴化钾GMP晶体。万博客户端登录 7758-02-3 371414
Potassium chlorate GMP 3811-04-9 384610
Potassium iodate GMP 7758-05-6 386811
Sodium acetate 3-hydrate (parenteral) GMP 6131-90-4 350944 R0-CEP 2018-100-Rev 00
磷酸二氢钠GMP USP万博客户端登录 7558-80-7 382015
Sodium dihydrogenphosphate 1-hydrate GMP 10049-21-5 351015.
Sodium dihydrogenphosphate 2-hydrate (parenteral) GMP 10028-24-7. 351142 R0-CEP 2017-177-Rev 01
Sodium fluoride GMP PH 7681-49-4 353314 R0-CEP 2016-103-Rev 01
钼酸钠2-水合物GMP pH值万博客户端登录 10102-40-6. 387614
钼酸钠2-水合物GMP QP万博客户端登录 10102-40-6. 387610
Sodium selenite GMP PH 10102-18-8 352514
Succinic acid 110-15-6 382216
Tri-sodium citrate 2-hydrate GMP 6132- 04- 3 383243
Urea GMP 57-13-6 381114

All our products suitable for use as excipients are produced in GMP conditions and meet the requirements for excipients according to the joint IPEC-PQG GMP Guide for pharmaceutical excipients.

We provide all documentation needed for excipients on request.

刺激uct range available:

CODE PRODUCT CAS号码
385910

ACETIC ACID 33% w/w GMP QP

64-19-7

384110

ACETIC ACID 80% w/w GMP QP

64-19-7

350214

ALUMINIUM POTASSIUM SULPHATE 12-HYDRATE GMP PH

7784-24-9

308210.

AMINOACETIC ACID (GLYCINE) gmp QP

56-40-6

305314

BENZOIC ACID gmp PH

65-85-0

383410

CALCIUM HYDROGEN PHOSPHATE ANHYDROUS GMP QP

7757-93-9.

388115

CHROMIUM (III) CHLORIDE 6-HYDRATE GMP USP

10060-12-5

388143

铬(III)氯化物6-水合物GMP USP肠外用途万博客户端登录

10060-12-5

305210

CITRIC ACID 1-HYDRATE gmp QP

5949-29-1

353510

COPPER (II) CARBONATE, BASIC (MALACHITE)GMP QP

12069-69-1

387815

COPPER (II) CHLORIDE 2-HYDRATE GMP USP

10125-13-0

387843

COPPER (II) CHLORIDE 2-HYDRATE GMP USP PARENTERAL USE

10125-13-0

352702

COPPER (II) OXIDE GMP PE

1317-38-0

380214

COPPER (II) SULPHATE 5-HYDRATE GMP PH

7758-99-8

380215

COPPER (II) SULPHATE 5-HYDRATE GMP USP

7758-99-8

382914

COPPER (II) SULPHATE ANHYDROUS GMP PH

7758-98-7

351514

di-SODIUM HYDROGEN PHOSPHATE 12-HYDRATE GMP PH

10039-32-4

351544

di-SODIUM HYDROGEN PHOSPHATE 12-HYDRATE GMP PH PARENTERAL USE

10039-32-4

385310

di-SODIUM HYDROGEN PHOSPHATE 2-HYDRATE GMP QP

10028-24-7.

383525

di-SODIUM HYDROGEN PHOSPHATE ANHYDROUS GMP PAB

7558-79-4

383502

di-SODIUM HYDROGEN PHOSPHATE ANHYDROUS GMP PE

7558-79-4

383510

di-SODIUM HYDROGEN PHOSPHATE ANHYDROUS GMP QP

7558-79-4

387744

EDTA,酸GMP p万博客户端登录H肠外用途

60-00-4

387742

EDTA, ACID GMP QP PARENTERAL USE

60-00-4

351414

EDTA,二钠盐2-水合物GMP pH值万博客户端登录

6381-92-6

351410

EDTA,二钠盐2-水合物GMP QP万博客户端登录

6381-92-6

306110

FUMARIC ACID gmp QP

110-17-8

350014

IRON (II) CHLORIDE 4-HYDRATE GMP PH

13478-10-9

382360

IRON (III) CHLORIDE SOL. 10-14% Fe w/w GMP PA

7705-08-0

382302

IRON (III) CHLORIDE SOL. 10-14% Fe w/w GMP PE

7705-08-0

382337

IRON (III) CHLORIDE SOL. 10-14% Fe w/w GMP QP MICROBIOLOGICALLY TESTED

7705-08-0

382305

IRON (III) CHLORIDE SOL. 10-14% Fe w/w GMP RE

7705-08-0

352914

iso-PROPYL ALCOHOL GMP PH

67-63-0

352910

iso-PROPYL ALCOHOL GMP QP

67-63-0

381414

L(+)-TARTARIC ACID GMP PH

87-69-4

381410

L(+)-TARTARIC ACID GMP QP

87-69-4

353042

MAGNESIUM ACETATE 4-HYDRATE GMP QP PARENTERAL USE

16674-78-5

385610

MAGNESIUM BROMIDE 6-HYDRATE GMP QP

13446-53-2

355510

MAGNESIUM FLUORIDE GMP QP

7783-40-6

384514

MAGNESIUM HYDROXIDE GMP PH

1309-42-8

353414

MAGNESIUM L-LACTATE 2-HYDRATE GMP PH

18917-93-6

352310

锰碳酸盐沉淀出GMP QP万博客户端登录

598-62-9

352342

锰碳酸盐沉淀出GMP QP万博客户端登录PARENTERAL USE

598-62-9

354142

MANGANESE (II) CHLORIDE 4-HYDRATE GMP QP PARENTERAL USE

13446-34-9

354115

MANGANESE (II) CHLORIDE 4-HYDRATE GMP USP

13446-34-9

352610

PHENOL GMP QP

108-95-2

387144

POTASSIUM ACETATE GMP PH PARENTERAL USE

127-08-2

351814

POTASSIUM BROMIDE GMP PH

7758-02-3

386402

POTASSIUM CARBONATE ANHYDROUS, GRANULATED GMP PE

584-08-7

384610

POTASSIUM CHLORATE GMP QP

3811-04-9

386514

碳酸钾GMP pH值万博客户端登录

298-14-6

386510

碳酸钾GMP QP万博客户端登录

298-14-6

350110

POTASSIUM NITRATE GMP QP

7757-79-1

350944

SODIUM ACETATE 3-HYDRATE GMP PH PARENTERAL USE

6131-90-4

306002

氯化钠GMP PE万博客户端登录

7647-14-5

306014.

氯化钠GMP pH值万博客户端登录

7647-14-5

306010.

氯化钠GMP QP万博客户端登录

7647-14-5

351015.

磷酸二氢钠磷酸二氢乳酸盐GMP USP万博客户端登录

10049-21-5

351114.

SODIUM DIHYDROGEN PHOSPHATE 2-HYDRATE GMP PH

13472-35-0

351142

SODIUM DIHYDROGEN PHOSPHATE 2-HYDRATE GMP QP PARENTERAL USE

13472-35-0

382015

SODIUM DIHYDROGEN PHOSPHATE ANHYDROUS GMP USP

7558-80-7

353314

SODIUM FLUORIDE GMP PH

7681-49-4

353310.

SODIUM FLUORIDE GMP QP

7681-49-4

386130

SODIUM HYDROXIDE 0.1M GMP DV

1310-73-2

386230

SODIUM HYDROXIDE 0.5M GMP DV

1310-73-2

386330.

氢氧化钠0.5M /氯化钠0.5M GMP DV万博客户端登录

.

384930

SODIUM HYDROXIDE 2M/SODIUM CHLORIDE 2M GMP DV

.

384830

SODIUM HYDROXIDE 3M GMP DV

1310-73-2

301314

SODIUM HYDROXIDE, PELLETS gmp PH

1310-73-2

301310

SODIUM HYDROXIDE, PELLETS gmp QP

1310-73-2

384050.

氢氧化钠溶胶SOL.32%w / w gmp de万博客户端登录

1310-73-2

384002

SODIUM HYDROXIDE SOL.32% w/w GMP PE

1310-73-2

384007

SODIUM HYDROXIDE SOL.32% w/w GMP PRS

1310-73-2

384305

SODIUM HYDROXIDE SOL.50% w/w GMP RE

1310-73-2

387614

钼酸钠2-HYDRATE GMP PH值万博客户端登录

10102-40-6.

387610

SODIUM MOLYBDATE 2-HYDRATE GMP QP

10102-40-6.

352502

SODIUM SELENITE GMP PE

10102-18-8

352514

SODIUM SELENITE GMP PH

10102-18-8

352544

SODIUM SELENITE GMP PH PARENTERAL USE

10102-18-8

352507

亚硒酸钠GMP PRS万博客户端登录

10102-18-8

352510.

SODIUM SELENITE GMP QP

10102-18-8

385110

SODIUM SUCCINATE 6-HYDRATE GMP QP

6106-21-4

380714

SODIUM SULPHATE 10-HYDRATE GMP PH

7727-73-3

380710

硫酸钠10水合物GMP QP万博客户端登录

7727-73-3

380502

SODIUM SULPHATE ANHYDROUS GMP PE

7757-82-6

380514

SODIUM SULPHATE ANHYDROUS GMP PH

7757-82-6

380814

SODIUM THIOSULPHATE 5-HYDRATE GMP PH

10102-17-7

380810

SODIUM THIOSULPHATE 5-HYDRATE GMP QP

10102-17-7

382216

SUCCINIC ACID GMP NF

110-15-6

381210

TIN (II) CHLORIDE 2-HYDRATE GMP QP

10025-69-1

383243

tri-SODIUM CITRATE 2-HYDRATE GMP USP PARENTERAL USE

6132-04-3

381114

尿素GMP万博客户端登录 pH.

57-13-6

381115

尿素GMP万博客户端登录 USP.

57-13-6

351214

醋酸锌2-水合物GMP pH值万博客户端登录

5970-45-6

351244

醋酸锌2-水合物GMP pH值万博客户端登录PARENTERAL USE

5970-45-6

304814

ZINC OXIDE gmp PH

1314-13-2

353115

ZINC SULPHATE 1-HYDRATE GMP USP

7446-19-7

351314

ZINC SULPHATE 7-HYDRATE GMP PH

7446-20-0

351310.

ZINC SULPHATE 7-HYDRATE GMP QP

7446-20-0

351343

ZINC SULPHATE 7-HYDRATE GMP USP PARENTERAL USE

7446-20-0

一个特殊的品位manuf时必须使用的水acturing APIs and excipients intended to be used in sterile, parenteral drug products. We manufacture “Parenteral grade” products using purified water with an endotoxins limit lower than 0.25 EU/ml and a total aerobic count limit lower than 100 cfu/ml.

用于注射使用的大部分时间矿盐需要有low endotoxin content. Pharmacopoeias would indicate the maximum level of endotoxins allowed depending on the product. In other cases the level of endotoxins is specified by our customers.

High-purity salts for parenteral use are manufactured in our GMP plant in Venta de Baños under strict GMP, ICH Q7 compliant conditions.

These salts can be used in parenteral products:

  • Solutions and powders for injection
  • Solutions for dialysis
  • 输液的解决方案

我们提供the following products. However, we can produce any of our salts in low-endotoxin grade on demand.

CODE PRODUCT CAS Number
3400

di-sodium hydrogen phosphate 12-H2O parenteral GMP


10039-32-4

3403


EDTA, disodium salt 2 hydrate parenteral GMP


6381-92-6

3407


醋酸镁4水合物肠胃外使用GMP万博客户端登录


16674-78-5

3405


Potassium acetate parenteral use GMP



127-08-2

3406


Potassium bromide parenteral use GMP


7758-02-3

3402


Potassium dihidrogen phosphate parenteral use GMP



7778-77-0

3404


Sodium acetate 3 hydrate parenteral use GMP


6131-90-4

3401


二氢磷酸钠2 H2O肠胃外GMP万博客户端登录



13472-35-0

3413


tri-Sodium citrate 2 hydrate parenteral use GMP

6132-04-3

3414


Zinc acetate 2 hydrate parenteral use GMP



5970-45-6