High-Purity Potassium and Magnesium Salts for Medicinal Products
Pharmaceutical companies all over the world rely on the quality and safety of our high-purity potassium and magnesium salts. The properties and the purity of our products comply with the strict requirements of international pharmacopoeias. Competent authorities inspect and certify the consistent implementation of international GMP-standards - all the way from production plants and manufacturing, to packaging and labelling, to documentation. We supply the following products for pharmaceutical applications:
|Potassium Chloride 99.9 % KCl Ph. Eur., USP||DIN EN ISO 9001 ff., GMP, CEP, kosher, halal|
|Potassium Sulphate 99.9 % K2SO4 Ph. Eur., FCC, E 515||DIN EN ISO 9001 ff., GMP, kosher, halal|
Compliant with Pharmacopoeias and Extremely Versatile
Potassium plays an important role in the human electrolyte metabolism. Used medicinally, they it may save lives. Products containing this minerals are therefore used in many medical areas.
Potassium Chloride 99.9 % KCl Ph. Eur., USP is also highly versatile – among other applications it is used for potassium therapy: in infusions, haemodialysis and injection solutions, for enteral and parenteral nutrition, in potassium tablets, dietary salts, sports nutrition and mineral beverages. It is also used for the purification of insulin. In pharmaceutical biotechnology, it serves as a source for the macro-nutrient potassium required by micro-organisms.
Potassium Sulphate 99.9% K2SO4, Ph. Eur., FCC, E 515 is used as a raw material for medicinal preparations by the pharmaceutical industry. One of these applications is the production of antibiotics.
Strict Quality Controls, Continuous Analyses
The salts manufactured by K+S KALI GmbH for pharmaceutical application are all of natural origin. Special technology and complex techniques are used to process these natural crude salts into high-purity products for pharmaceutical purposes. Each individual production phase is constantly monitored to meet our strict quality and safety standards. Our implementation of the Good Manufacturing Practice (GMP) is certified by the Darmstadt Regional Administrative Council and is additionally controlled by the U.S. Food and Drug Administration (FDA). And of course our pharmaceutical-grade salts for use in medicinal preparations are certified in accordance with DIN EN 9001ff, as being both kosher and halal. We continuously verify all relevant chemical and physical properties, specifically those pertaining to the requirements of international pharmacopoeias.
Potassium Chloride with CEP Certificate – More Service to our Customers
Our Potassium Chloride 99.9 % KCl Ph. Eur., USP holds the `Certificate of Suitability to the Monographs of the European Pharmacopoeia´ (CEP), issued by the European Directorate for the Quality of Medicines (EDQM). To our customers in the pharmaceutical industry, this certificate translates into faster approval of the corresponding drugs.