
Black Spots on Tablets, Grey Smudges
Source : Yenchen Technical Process Consultant, Dr. Fred Rowley
Problem:
- Colored spots in the coating on the tablets. (usually grey, sometimes black, sometimes unusual color).
- Not every tablet will have the defect; only those that receive a sharp, hard particle of Titanium oriented so as to initiate a rub or that have a particle of zinc stearate on the surface of the tablet.
Root Causes:
- High content of titanium dioxide in the coating material.
- Zinc stearate in the formula.
- Iron oxides trapped in the coating pan.
- No passivation performed
- Interaction of factors.
Important note:
This can be a highly complex problem involving titanium dioxide, zinc stearate, stainless steel and iron oxides.
If you have any technical questions, please contact with Grace Chiang Email:grace.chiang@yenchen.com.tw
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