We have been producing high purity salts for pharmaceutical and veterinary companies for more than 15 years. Quality Chemicals is a reliable supplier to the world's largest companies in this sector.

Quality Chemicals offers a comprehensive portfolio of essential pharma ingredients. These include APIs, intermediates, excipients, starting material, solvents and reagents.

Our dedicated pharma team provides a network of services:

  • Regulatory support
  • GMP product repack
  • Change management notification
  • Product documentation
  • Transparent supply chain: lot traceability, supplier audits, suppliers data sharing etc.
  • Scale from lab to full production
  • Collaborative development; optimised particle size, custom mixtures, etc.
  • Customer audits

One of our two plants, our GMP plant in Venta de Baños, has been operating since 2004 and complies with GMP guidelines ICH-Q7 – EU-GMP part II. It mainly produces raw material for the pharma, veterinary and biopharmaceuticals industries.

We offer our salts mainly for two types of customers:

For this group we directly supply raw materials where usually no GMP grade will be asked for but rather according to any pharmacopeia:

  • 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.

All our products suitable for use as API are produced in GMP conditions and meet the requirements of the European GMP Guide for the manufacturing of drug products part II, active substances (ICH Q7).

For APIs we provide support to regulatory affairs:

  • CEP Certificate of Suitability of the European Pharmacopeia
  • ASMF Active Substance Master Files

All these documents can be provided in e-CTD format

APIs available:

ProductCAS No.CodeEU ASMFCEPUS DMF

Acetic Acid 80% w/w GMP

64-19-7

384110

Ammonium chloride GMP

12125-02-9

350314R0-CEP 2021-326-Rev 00

Ammonium molybdate 4 hydrate GMP

12054-85-2

386915

Antimony potassium tartrate GMP

28300-74-5

388715

Calcium acetate anhydrous GMP

62-54-4

382110

Calcium hydrogenphosphate anhydrous GMP

7757-93-9

383410

Chromium (III) chloride 6-hydrate GMP

10125-13-0

388115

Zinc acetate 2-hydrate GMP

5970-45-6

351244R0-CEP 2018-177-Rev 01

Zinc oxide GMP

1314-13-2

304814

Cobalt (II) chloride 6-hydrate GMP

7791-13-1

386010

Copper (II) Chloride 2-hydrate GMP

10125-13-0

387843

Copper (II) oxide GMP

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 GMP

10039-32-4

351544CEP 2017-233-Rev 02

EDTA, iron (III) sodium salt 3-hydrate

18154-32-0

333310

Iron (III) chloride sol. 10-14% GMP

7705-08-0

382337

L(+)-Tartaric acid GMP

87-69-4

381414

Magnesium acetate 4-hydrate (parenteral) GMP

16674-78-5

353042R0-CEP 2017-280-Rev 01

Magnesium bromide 6-hydrate GMP

16674-78-5

385610

Magnesium fluoride GMP

16674-78-5

355510

Magnesium hydroxide GMP

1309-42-8

384514

Magnesium L-lactate 2-hydrate GMP

18917-93-6

353414

Manganese carbonate precipitated GMP

598-62-9

352310

Manganese (II) chloride 4-hydrate GMP

13446-34-9

354115

Nickel sulfate 6-hydrate GMP

10101-97-0

387543

Phenol GMP

108-95-2

352610

Potassium acetate GMP

127-08-2

387144CEP 2018-028-Rev 01

Potassium bromide GMP

7758-02-3

351814

Potassium bromide GMP Crystal.

7758-02-3

371414

Potassium chlorate GMP

3811-04-9

384610

Potassium iodate GMP

7758-05-6

386811

Sodium acetate 3-hydrate GMP

6131-90-4

350944CEP 2018-100-Rev 01

Sodium dihydrogen phosphate anhydrous GMP

7558-80-7

382015

Sodium dihydrogenphosphate 1-hydrate GMP

10049-21-5

351015

Sodium dihydrogenphosphAte 2-hydrate GMP

10028-24-7

351142CEP 2017-177-Rev 02

Sodium fluoride GMP

7681-49-4

353314CEP R1-CEP 2016-103-Rev 00

Sodium molybdate 2-hydrate GMP

10102-40-6

387614

Sodium molybdate 2-hydrate GMP

10102-40-6

387610

Sodium selenite GMP

10102-18-8

352514

Succinic acid GMP

110-15-6

382216

Tri-sodium citrate 2-hydrate GMP

6132- 04- 3

383215

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.

Product range available:

CODE PRODUCT CAS NUMBER
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 PH.EUR.11ED.

7784-24-9

308210

AMINOACETIC ACID (GLYCINE) gmp QP PH.EUR.11ED.

56-40-6

350314

AMMONIUM CHLORIDE GMP PH PH.EUR.11ED.

12125-02-9

350310

AMMONIUM CHLORIDE GMP QP PH.EUR.11ED.,USP-NF 2022

12125-02-9

386915

AMMONIUM MOLYBDATE 4-HYDRATE GMP USP USP-NF 2022

12054-85-2

305314

BENZOIC ACID gmp PH PH.EUR.11ED.

65-85-0

308814

BENZYL ALCOHOL GMP PH

100-51-6

383410

CALCIUM HYDROGEN PHOSPHATE ANHYDROUS GMP QP JP 16,PH.EUR.11ED.,USP-NF 2022

7757-93-9

388143

CHROMIUM (III) CHLORIDE 6-HYDRATE GMP USP PARENTERAL USE USP-NF 2022

10060-12-5

388115

CHROMIUM (III) CHLORIDE 6-HYDRATE GMP USP USP-NF 2022

10060-12-5

305210

CITRIC ACID 1-HYDRATE gmp QP CNFSS,PH.EUR.11ED.,USP-NF 2022

5949-29-1

386010

COBALT (II) CHLORIDE 6-HYDRATE GMP QP

7791-13-1

353510

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

12069-69-1

387843

COPPER (II) CHLORIDE 2-HYDRATE GMP USP PARENTERAL USE USP-NF 2022

10125-13-0

387815

COPPER (II) CHLORIDE 2-HYDRATE GMP USP USP-NF 2022

10125-13-0

352702

COPPER (II) OXIDE GMP PE

1317-38-0

380239

COPPER (II) SULPHATE 5-HYDRATE GMP PH MICROBIOLOGICALLY TESTED PH.EUR.11ED.

7758-99-8

380214

COPPER (II) SULPHATE 5-HYDRATE GMP PH PH.EUR.11ED.

7758-99-8

380215

COPPER (II) SULPHATE 5-HYDRATE GMP USP USP-NF 2022

7758-99-8

382914

COPPER (II) SULPHATE ANHYDROUS GMP PH PH.EUR.11ED.

7758-98-7

351544

di-SODIUM HYDROGEN PHOSPHATE 12-HYDRATE GMP PH PARENTERAL USE PH.EUR.11ED.

10039-32-4

351514

di-SODIUM HYDROGEN PHOSPHATE 12-HYDRATE GMP PH PH.EUR.11ED.

10039-32-4

385310

di-SODIUM HYDROGEN PHOSPHATE 2-HYDRATE GMP QP PH.EUR.11ED.,USP-NF 2022

10028-24-7

383525

di-SODIUM HYDROGEN PHOSPHATE ANHYDROUS GMP PAB PH.EUR.11ED.,USP-NF 2022

7558-79-4

383502

di-SODIUM HYDROGEN PHOSPHATE ANHYDROUS GMP PE PH.EUR.11ED.,USP-NF 2022

7558-79-4

383510

di-SODIUM HYDROGEN PHOSPHATE ANHYDROUS GMP QP PH.EUR.11ED.,USP-NF 2022

7558-79-4

387744

EDTA, ACID GMP PH PARENTERAL USE PH.EUR.11ED.

60-00-4

387742

EDTA, ACID GMP QP PARENTERAL USE PH.EUR.11ED.,USP-NF 2023

60-00-4

381710

EDTA, ACID GMP QP USP-NF 2022,PH.EUR.11ED.

60-00-4

351414

EDTA, DISODIUM SALT 2-HYDRATE GMP PH PH.EUR.11ED.

6381-92-6

351410

EDTA, DISODIUM SALT 2-HYDRATE GMP QP PH.EUR.11ED.,USP-NF 2022

6381-92-6

306116

FUMARIC ACID gmp NF USP-NF 2022

110-17-8

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

382304

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

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

380315

IRON (II) SULPHATE 7-HYDRATE GMP USP USP-NF 2022

7782-63-0

352914

iso-PROPYL ALCOHOL GMP PH PH.EUR.11ED.

67-63-0

352910

iso-PROPYL ALCOHOL GMP QP PH.EUR.11ED.,USP-NF 2022

67-63-0

381414

L(+)-TARTARIC ACID GMP PH PH.EUR.11ED.

87-69-4

381410

L(+)-TARTARIC ACID GMP QP PH.EUR.11ED.,USP-NF 2022

87-69-4

353042

MAGNESIUM ACETATE 4-HYDRATE GMP QP PARENTERAL USE PH.EUR.11ED.

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 PH.EUR.11ED.

1309-42-8

353414

MAGNESIUM L-LACTATE 2-HYDRATE GMP PH PH.EUR.11ED.

18917-93-6

352310

MANGANESE CARBONATE PRECIPITATED GMP QP

598-62-9

352342

MANGANESE CARBONATE PRECIPITATED GMP QP PARENTERAL USE

598-62-9

354142

MANGANESE (II) CHLORIDE 4-HYDRATE GMP QP PARENTERAL USE USP-NF 2022

13446-34-9

354115

MANGANESE (II) CHLORIDE 4-HYDRATE GMP USP USP-NF 2025

13446-34-9

352811

MANGANESE (II) SULPHATE 1-HYDRATE GMP FCC

10034-96-5

352602

PHENOL GMP PE PH.EUR.11ED.,USP-NF 2025

108-95-2

352610

PHENOL GMP QP PH.EUR.11ED.,USP-NF 2022

108-95-2

371310

POTASSIUM ACETATE GMP (low Na) QP PH.EUR.11ED.,USP-NF 2022

127-08-2

387144

POTASSIUM ACETATE GMP PH PARENTERAL USE PH.EUR.11ED.

127-08-2

371414

POTASSIUM BROMIDE GMP Crystal. PH PH.EUR.11ED.

7758-02-3

351814

POTASSIUM BROMIDE GMP PH PH.EUR.11ED.

7758-02-3

386402

POTASSIUM CARBONATE ANHYDROUS, GRANULATED GMP PE PH.EUR.11ED.

584-08-7

384610

POTASSIUM CHLORATE GMP QP

3811-04-9

350710

POTASSIUM DIHYDROGEN PHOSPHATE GMP QP PH.EUR.11ED.,USP-NF 2022

7778-77-0

386514

POTASSIUM HYDROGEN CARBONATE GMP PH PH.EUR.11ED.

298-14-6

386510

POTASSIUM HYDROGEN CARBONATE GMP QP PH.EUR.11ED.,USP-NF 2022

298-14-6

386811

POTASSIUM IODATE GMP FCC FCC XIII

7758-05-6

350110

POTASSIUM NITRATE GMP QP

7757-79-1

350807

POTASSIUM SULPHATE GMP PRS

7778-80-5

350944

SODIUM ACETATE 3-HYDRATE GMP PH PARENTERAL USE PH.EUR.11ED.

6131-90-4

350910

SODIUM ACETATE 3-HYDRATE GMP QP PH.EUR.11ED.,USP-NF 2022

6131-90-4

306002

SODIUM CHLORIDE gmp PE CP 2010,JP 16,PH.EUR.11ED.,USP-NF 2022

7647-14-5

306014

SODIUM CHLORIDE gmp PH JP 16,PH.EUR.11ED.,USP-NF 2022

7647-14-5

306010

SODIUM CHLORIDE gmp QP JP 16,PH.EUR.11ED.,USP-NF 2022

7647-14-5

351043

SODIUM DIHYDROGEN PHOSPHATE 1-HYDRATE GMP USP PARENTERAL USE USP-NF 2022

10049-21-5

351015

SODIUM DIHYDROGEN PHOSPHATE 1-HYDRATE GMP USP USP-NF 2022

10049-21-5

351114

SODIUM DIHYDROGEN PHOSPHATE 2-HYDRATE GMP PH PH.EUR.11ED.

13472-35-0

351142

SODIUM DIHYDROGEN PHOSPHATE 2-HYDRATE GMP QP PARENTERAL USE PH.EUR.11ED.

13472-35-0

351110

SODIUM DIHYDROGEN PHOSPHATE 2-HYDRATE GMP QP PH.EUR.11ED.,USP-NF 2022

13472-35-0

382015

SODIUM DIHYDROGEN PHOSPHATE ANHYDROUS GMP USP USP-NF 2022

7558-80-7

353314

SODIUM FLUORIDE GMP PH PH.EUR.11ED.

7681-49-4

353310

SODIUM FLUORIDE GMP QP PH.EUR.11ED.,USP-NF 2022

7681-49-4

386130

SODIUM HYDROXIDE 0.1M GMP DV

1310-73-2

386230

SODIUM HYDROXIDE 0.5M GMP DV

1310-73-2

386330

SODIUM HYDROXIDE 0.5M/SODIUM CHLORIDE 0.5M GMP DV

.

384930

SODIUM HYDROXIDE 2M/SODIUM CHLORIDE 2M GMP DV

.

384830

SODIUM HYDROXIDE 3M GMP DV

1310-73-2

301314

SODIUM HYDROXIDE, PELLETS gmp PH PH.EUR.11ED.

1310-73-2

301310

SODIUM HYDROXIDE, PELLETS gmp QP PH.EUR.11ED.,USP-NF 2022

1310-73-2

384050

SODIUM HYDROXIDE SOL.32% w/w GMP DE

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

384004

SODIUM HYDROXIDE SOL.32% w/w GMP PS

1310-73-2

384305

SODIUM HYDROXIDE SOL.50% w/w GMP RE

1310-73-2

387644

SODIUM MOLYBDATE 2-HYDRATE GMP PH PARENTERAL USE PH.EUR.11ED.

10102-40-6

387614

SODIUM MOLYBDATE 2-HYDRATE GMP PH PH.EUR.11ED.

10102-40-6

387610

SODIUM MOLYBDATE 2-HYDRATE GMP QP

10102-40-6

387642

SODIUM MOLYBDATE 2-HYDRATE GMP QP PARENTERAL USE

10102-40-6

352502

SODIUM SELENITE GMP PE PH.EUR.11ED.

10102-18-8

352544

SODIUM SELENITE GMP PH PARENTERAL USE PH.EUR.11ED.

10102-18-8

352514

SODIUM SELENITE GMP PH PH.EUR.11ED.

10102-18-8

352507

SODIUM SELENITE GMP PRS CNFSS,PH.EUR.11ED.

10102-18-8

352510

SODIUM SELENITE GMP QP BP-VET 2012

10102-18-8

385110

SODIUM SUCCINATE 6-HYDRATE GMP QP USP-NF 2022

6106-21-4

380714

SODIUM SULPHATE 10-HYDRATE GMP PH PH.EUR.11ED.

7727-73-3

380710

SODIUM SULPHATE 10-HYDRATE GMP QP PH.EUR.11ED.,USP-NF 2022

7727-73-3

380502

SODIUM SULPHATE ANHYDROUS GMP PE PH.EUR.11ED.

7757-82-6

380514

SODIUM SULPHATE ANHYDROUS GMP PH PH.EUR.11ED.

7757-82-6

380814

SODIUM THIOSULPHATE 5-HYDRATE GMP PH PH.EUR.11ED.

10102-17-7

380810

SODIUM THIOSULPHATE 5-HYDRATE GMP QP PH.EUR.11ED.,USP-NF 2022

10102-17-7

382216

SUCCINIC ACID GMP NF USP-NF 2024

110-15-6

382246

SUCCINIC ACID GMP PE MICROBIOLOGICALLY TESTED ACS 11 ED.,CHP,JPE,USP-NF 2024

110-15-6

381210

TIN (II) CHLORIDE 2-HYDRATE GMP QP

10025-69-1

383244

tri-SODIUM CITRATE 2-HYDRATE GMP PH PARENTERAL USE PH.EUR.11ED.

6132-04-3

383243

tri-SODIUM CITRATE 2-HYDRATE GMP USP PARENTERAL USE USP-NF 2022

6132-04-3

381114

UREA GMP PH PH.EUR.11ED.

57-13-6

381115

UREA GMP USP USP-NF 2022

57-13-6

351244

ZINC ACETATE 2-HYDRATE GMP PH PARENTERAL USE PH.EUR.11ED.

5970-45-6

351214

ZINC ACETATE 2-HYDRATE GMP PH PH.EUR.11ED.

5970-45-6

304814

ZINC OXIDE gmp PH PH.EUR.11ED.

1314-13-2

353115

ZINC SULPHATE 1-HYDRATE GMP USP USP-NF 2024

7446-19-7

351314

ZINC SULPHATE 7-HYDRATE GMP PH PH.EUR.11ED.

7446-20-0

351310

ZINC SULPHATE 7-HYDRATE GMP QP PH.EUR.11ED.,USP-NF 2022

7446-20-0

351343

ZINC SULPHATE 7-HYDRATE GMP USP PARENTERAL USE USP-NF 2022

7446-20-0

A special grade of water has to be used when manufacturing 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.

Most of the time mineral salts for injectable use need to have 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
  • Solutions for infusion

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

CODEPRODUCTCAS Number
3515

di-sodium hydrogen phosphate 12-H2O parenteral GMP


10039-32-4

3817


EDTA, acid GMP

60-00-4

3514


EDTA, disodium salt 2 hydrate parenteral GMP


6381-92-6

3530


Magnesium acetate 4 hydrate parenteral use GMP


16674-78-5

3871


Potassium acetate parenteral use GMP



127-08-2

3518


Potassium bromide parenteral use GMP


7758-02-3

3402


Potassium dihidrogen phosphate parenteral use GMP



7778-77-0

3509


Sodium acetate 3 hydrate parenteral use GMP


6131-90-4

3511


Sodium dihydrogen phosphate 2 H2O parenteral GMP



13472-35-0

3832


tri-Sodium citrate 2 hydrate parenteral use GMP

6132-04-3

3512


Zinc acetate 2 hydrate parenteral use GMP



5970-45-6