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Appearance
|
Pale yellow crystalline powder
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|
Identification
|
-
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|
By IR
|
IR Spectrum of sample should be concordant with the IR spectrum of Reference Standard
|
|
By HPLC
|
The RT of sample should match with RT of Working Standard
|
|
Solubility
|
Soluble in Chloroform, methanol and dichloromethane, insoluble in water
|
|
Melting range
|
132°C to 133°C
|
|
Loss on drying
|
NMT 1.0 %
|
|
Related substance (by HPLC)
|
-
|
|
2-chlorotritanol
|
NMT 1.50%
|
|
Any other single impurity
|
NMT 0.50%
|
|
Total impurities
|
NMT 2.0%
|
|
Assay
|
NLT 98.0%
|