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Active pharmaceutical ingredients (APIs)

New EMPROVE® api products: Urea cryst. and potassium chloride

For the sake of patient safety, raw materials to be used as active pharmaceutical ingredients (API) must be supplied in reliable and provable quality and purity. That’s why Merck Millipore now offers you potassium chloride and – as one of the first suppliers worldwide – urea crystalline in API grade quality. We thus further extend our successful EMPROVE® api product line of raw materials combining outstanding API grade quality with tailor-made documentation. Our EMPROVE® api raw materials meet global regulatory requirements (Ph Eur, BP, USP) facilitating worldwide drug approval.

Now from Merck Millipore: urea in API quality
Urea is widely used in topical dermatological applications. Synthesized for the first time back in 1828, it was the first organic compound ever to be produced from an inorganic precursor. Although we’ve come a long way since these early days of organic chemistry, only very few have been able to manufacture urea for industrial applications in API grade quality. As one of the first suppliers worldwide, Merck Millipore offers you urea in EMPROVE® api quality with even higher purity, produced in strict compliance to the ICH Q7 Good Manufacturing Practice guidelines that are mandatory for actives.

Also new: EMPROVE® api Potassium chloride
Another brand-new addition to our EMPROVE® api portfolio is potassium chloride. Potassium chloride is used, for example, in the treatment of hypokalemia and digitalis poisoning, as an electrolyte replenisher and in nutritional supplements. Like every EMPROVE® api product, potassium chloride suitable for use as active pharmaceutical ingredient is available with an Active Substance Master File (EU-ASMF), and/or US Drug Master File (US-DMF).

The new products:
108432 - Urea cryst. suitable for use as an active pharmaceutical ingredient EMPROVE® api Ph Eur,BP

100320 - Potassium chloride suitable for use as an active pharmaceutical ingredient EMPROVE® api Ph Eur,BP,JP,USP,E 508,FCC

 

For more information, please contact us.
Click here to learn more about EMPROVE® api.

© Merck KGaA, Darmstadt, Germany, 2013


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