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Sulphonamide of Glibenclamide :-
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SR.NO
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TEST
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SPECIFICATION
|
|
1
|
Description
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An Almost white to slight yellow crystalline powder.
|
|
2
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Solubility
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Soluble in N,N- Dimethyl formamide,
Very slightly soluble in ethanol.
Practically insoluble in chloroform.
|
|
3
|
IR Spectrum
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Must Comply
|
|
4
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Melting Range
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204°C to 212°C
|
|
5
|
LOD
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NMT 0.5 % w/w
|
|
6
|
Related Substance
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3,5-Dichloro Analog NMT 0.2 %
Sulfonamide Diner NMT 1.0 %
|
|
7
|
Assay
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97 % to 101 %
|
|
8
|
Residual Solvents
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1.Methanol NMT 3000 PPM
2. Acetone NMT 3000 PPM
3. Ethylene Di chloride 1870 PPM
|
|
