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Mirtazapine
Item |
Standard |
Description |
white to off white crystalline powder |
Water |
NMT1.0%(anhydrous compound)
1.0%-3.5%(hemihydrate) |
Related substances |
Single impurity: NMT 0.1%
Total impurity: NMT 0.5% |
Residue on ignition |
NMT 0.1% |
Heavy metal |
NMT 20ppm |
Assay |
98.0%-102.0% |
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