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- Posts: 6
- Joined: Wed Dec 13, 2006 11:25 am
I have come across a difficult situation in interpreting the impurities in Timolol Eye Drops.
As per BP monograph:
In the chromatogram obtained with solution (2) the area of any secondary peak , other than the peak corresponding to maleic acid, is not greater than the area of the peak obtained with solution (1) (0.4%) and not more than two such peaks have an area greater than that of the peak obtained with solution (3) (0.2%).
Does it mean:
Highest unknown impurity: Not more than 0.4%
Sum of any other two highest impurities (excluding highest unknown impurity of 0.4%): Note more than 0.2%
If not what is the correct interpretation?
rgds.
