cphi-onlineJune 17, 2021
Tag: Monosodium Phosphate , API , CEP
Dr. Paul Lohmann® recently received a CEP (Certificate of Suitability to the European Pharmacopoeia) for Monosodium Phosphate 2-hydrate, which enables a customer to register a drug in several countries in a cost-saving and simplified way. Since this Monosodium Phosphate 2-hydrate meets the purity requirements of Ph.Eur. and has a low endotoxin content, it is ideally suited for oral and parenteral dosage forms.
In the pharmaceutical industry, Monosodium Phosphate 2-hydrate is used either as active pharmaceutical ingredient (API) against hypophosphataemia and constipation or as an excipient for buffering reasons. In addition, it is widely used in biomanufacturing processes as it is part of phosphate buffered saline (PBS) and is essential for cell culture media as well as for purification and final liquid formulation.
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