Intermediate for Cinacalcet
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Parameter |
Specifications Limit |
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Appearance |
A off white to light brown colored powder.
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|
Identification by IR |
The IR spectrum of the sample should contain characteristic absorption maxima in the range of 1640-1620 cm-1 and 701-681 cm-1 .
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Identification by HPLC |
The retention time of principle peakobtained in the test solution should match with that of the 3-(Trifluoromethyl) cinnamic Acid (TFMCA) peak obtained in the standard solution in the test assay by HPLC.
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Loss on drying (at 60⁰ under vacuum for 3 hrs.)
|
NMT 1.00 % w/w
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Assay by HPLC |
In between 98.0% to 102.0% |
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Related Substances by HPLC
|
NMT .30% NMT 1.0% |