Quality

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Quality Data Sheets New

Ceolus™­MCC Keeps Nitrites to­ 0.1 ppm

Ceolus™ KG　Ceolus™ UF　Ceolus™ PH　

Ceolus™ provides nitrite concentrations of 0.1 ppm or less across our current primary product lines. Test results confirming these levels are provided in every Certificate of Analysis. It helps to reduce the risk of nitrosamine formation.

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Quality Data Sheets New

Celphere™ MCC Sphere: Low Nitrite Levels

Celphere™　

Limiting nitrite levels in core excipients, such as Celphere™, lowers the risk of nitrosamine formation. Celphere™ shows nitrite levels below 0.1 ppm to reduce this risk in multi-particulate dosage forms.

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Quality Data Sheets New

Low levels of colored particles

Ceolus™ PH　

Our MCC products Ceolus™ shows low levels of TUPs because of our efforts including raw materials quality control, manufacturing equipment cleaning, in-process monitoring, installing particle removers and finished product testing.

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