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 GMP64-19-7384110
Ammonium chloride GMP12125-02-9350314R0-CEP 2021-326
Ammonium molybdate 4 hydrate GMP12054-85-2

386915
Calcium hydrogenphosphate anhydrous GMP7757-93-9383410
Chromium (III) chloride 6-hydrate GMP USP10125-13-0388115
Cinc acetate 2-hydrate (parenteral) GMP5970-45-6351244R0-CEP 2018-117-Rev 00
Cinc oxide GMP1314-13-2304814
Cobalt (II) chloride 6-hydrate GMP QP7791-13-1386010
Copper (II) oxide GMP1317-38-0352702
Copper (II) sulfate anhydrous GMP7758-98-7382914
Copper II sulphate 5-hydrate GMP7758-99-8380214
Copper(II) hydroxicarbonate(Malaquita) GMP12069-69-1353510
Di-sodium hydrogenphosphate 12-hydrate (parenteral) GMP10039-32-4351544R0-CEP 2017-233-Rev 01
L(+)-Tartaric acid GMP87-69-4381414
Magnesium acetate 4-hydrate (parenteral) GMP16674-78-5353042R0-CEP 2017-280-Rev 00
Magnesium bromide 6-hydrate GMP QP16674-78-5385610
Magnesium fluoride GMP QP16674-78-5355510
Magnesium hydroxide GMP1309-42-8384514
Magnesium L-lactate 2-hydrate GMP18917-93-6353414
Manganese carbonate precipitated GMP598-62-9352310
Phenol GMP108-95-2352610
Potassium acetate (parenteral) GMP127-08-2387144R0-CEP 2018-028-Rev 00
Potassium bromide GMP7758-02-3351814
Potassium bromide GMP Crystal.7758-02-3371414
Potassium chlorate GMP3811-04-9384610
Potassium iodate GMP7758-05-6386811
Sodium acetate 3-hydrate (parenteral) GMP6131-90-4350944R0-CEP 2018-100-Rev 00
Sodium dihydrogen phosphate anhydrous GMP USP7558-80-7382015
Sodium dihydrogenphosphate 1-hydrate GMP10049-21-5351015
Sodium dihydrogenphosphate 2-hydrate (parenteral) GMP10028-24-7351142R0-CEP 2017-177-Rev 01
Sodium fluoride GMP PH7681-49-4353314R0-CEP 2016-103-Rev 01
Sodium molybdate 2-hydrate GMP PH10102-40-6387614
Sodium molybdate 2-hydrate GMP QP10102-40-6387610
Sodium selenite GMP PH10102-18-8352514
Succinic acid110-15-6382216
Tri-sodium citrate 2-hydrate GMP6132- 04- 3383243
Urea GMP57-13-6381114

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:

CODEPRODUCTCAS 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

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

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

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

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, ACID GMP PH PARENTERAL USE

60-00-4

387742

EDTA, ACID GMP QP PARENTERAL USE

60-00-4

351414

EDTA, DISODIUM SALT 2-HYDRATE GMP PH

6381-92-6

351410

EDTA, DISODIUM SALT 2-HYDRATE GMP QP

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

MANGANESE CARBONATE PRECIPITATED GMP QP

598-62-9

354142

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

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

POTASSIUM HYDROGEN CARBONATE GMP PH

298-14-6

386510

POTASSIUM HYDROGEN CARBONATE GMP QP

298-14-6

350110

POTASSIUM NITRATE GMP QP

7757-79-1

350944

SODIUM ACETATE 3-HYDRATE GMP PH PARENTERAL USE

6131-90-4

306002

SODIUM CHLORIDE gmp PE

7647-14-5

306014

SODIUM CHLORIDE gmp PH

7647-14-5

306010

SODIUM CHLORIDE gmp QP

7647-14-5

351015

SODIUM DIHYDROGEN PHOSPHATE 1-HYDRATE GMP USP

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

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

1310-73-2

301310

SODIUM HYDROXIDE, PELLETS gmp QP

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

387614

SODIUM MOLYBDATE 2-HYDRATE GMP PH

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

SODIUM SELENITE GMP PRS

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

SODIUM SULPHATE 10-HYDRATE GMP QP

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

UREA GMP PH

57-13-6

381115

UREA GMP USP

57-13-6

351214

ZINC ACETATE 2-HYDRATE GMP PH

5970-45-6

351244

ZINC ACETATE 2-HYDRATE GMP PH 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

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
3400

di-sodium hydrogen phosphate 12-H2O parenteral GMP


10039-32-4

3403


EDTA, disodium salt 2 hydrate parenteral GMP


6381-92-6

3407


Magnesium acetate 4 hydrate parenteral use GMP


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


Sodium dihydrogen phosphate 2 H2O parenteral GMP



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