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Appearance
|
Off white colored powder
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|
Identification
|
-
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|
By IR
|
IR Spectrum of sample should be concordant with the IR Spectrum of Working Standard
|
|
By HPLC
|
The RT of sample should match with RT of Working Standard
|
|
Melting range
|
154°C - 156°C
|
|
Loss on drying
|
NMT 0.5%
|
|
Related substance (by HPLC)
|
-
|
|
2-chloro benzoic acid
|
NMT 1.0%
|
|
Any other impurity
|
NMT 0.5%
|
|
Total impurities
|
NMT 1.5%
|
|
Assay (by titration)
|
98.0% to 102.0%
|