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:
| Product | CAS No. | Code | EU ASMF | CEP | US DMF |
|---|---|---|---|---|---|
Acetic Acid 80% w/w GMP | 64-19-7 | 384110 |  | ||
Ammonium chloride GMP | 12125-02-9 | 350314 | R0-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 | 351244 | R0-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 | 351544 | CEP 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 | 353042 | R0-CEP 2017-280-Rev 00 | ||
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 | 387144 | CEP 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 | 350944 | CEP 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 | 351142 | CEP 2017-177-Rev 02 | ||
Sodium fluoride GMP | 7681-49-4 | 353314 | CEP 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 |
7784-24-9 |
| 308210 | AMINOACETIC ACID (GLYCINE) gmp QP |
56-40-6 |
| 350314 | AMMONIUM CHLORIDE GMP PH |
12125-02-9 |
| 350310 | AMMONIUM CHLORIDE GMP QP |
12125-02-9 |
| 386915 | AMMONIUM MOLYBDATE 4-HYDRATE GMP USP |
12054-85-2 |
| 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 |
| 386010 | COBALT (II) CHLORIDE 6-HYDRATE GMP QP |
7791-13-1 |
| 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 |
| 380239 | COPPER (II) SULPHATE 5-HYDRATE GMP PH MICROBIOLOGICALLY TESTED |
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, ACID GMP PH PARENTERAL USE |
60-00-4 |
| 381710 | EDTA, ACID GMP QP |
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 |
| 306116 | FUMARIC ACID gmp NF |
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 |
7782-63-0 |
| 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 |
| 352342 | MANGANESE CARBONATE PRECIPITATED GMP QP PARENTERAL USE |
598-62-9 |
| 354542 | 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 |
| 371310 | POTASSIUM ACETATE GMP (low Na) QP |
127-08-2 |
| 387144 | POTASSIUM ACETATE GMP PH PARENTERAL USE |
127-08-2 |
| 371414 | POTASSIUM BROMIDE GMP Crystal. PH |
7758-02-3 |
| 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 |
| 386811 | POTASSIUM IODATE GMP FCC |
7758-05-6 |
| 350110 | POTASSIUM NITRATE GMP QP |
7757-79-1 |
| 350944 | SODIUM ACETATE 3-HYDRATE GMP PH PARENTERAL USE |
6131-90-4 |
| 350910 | SODIUM ACETATE 3-HYDRATE GMP QP |
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 |
| 351110 | SODIUM DIHYDROGEN PHOSPHATE 2-HYDRATE GMP QP |
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 |
| 384305 | SODIUM HYDROXIDE SOL.50% w/w GMP RE |
1310-73-2 |
| 387614 | SODIUM MOLYBDATE 2-HYDRATE GMP PH |
10102-40-6 |
| 387644 | SODIUM MOLYBDATE 2-HYDRATE GMP PH PARENTERAL USE |
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 |
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 |
| 383244 | tri-SODIUM CITRATE 2-HYDRATE GMP PH PARENTERAL USE |
6132-04-3 |
| 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.
| CODE | PRODUCT | CAS Number |
|---|---|---|
| 3515 | di-sodium hydrogen phosphate 12-H2O parenteral GMP | 10039-32-4 |
| 3817 |
| 60-00-4 |
| 3514 |
| 6381-92-6 |
| 3530 |
| 16674-78-5 |
| 3871 |
| 127-08-2 |
| 3518 |
| 7758-02-3 |
| 3402 |
| 7778-77-0 |
| 3509 |
| 6131-90-4 |
| 3511 |
| 13472-35-0 |
| 3832 |
| 6132-04-3 |
| 3512 |
| 5970-45-6 |
