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1 Description A white to off-white powder.
2 Identification by
IR The IR spectrum of sample should be concordant with the spectrum of the standard
b) HPLC The retention time of the major peak in the chromatogram of the sample preparation corresponds to that of the system suitability preparation obtained as directed in the chromatographic purity by HPLC
3 Solubility Soluble in Methanol and water.
4 Water (by KF) Not more than 1.00%.w/w
5 Sulphated ash Not more than 0.20%.w/w
6 Loss on Drying(105 ºC for 3hours) Not more than 2.0%.w/w
7 Melting range Between 155 ºC and 163 ºC
8 Chromatographic Purity
(by HPLC.% area)
a) Purity Not less than 99.00%
b) 2-Pyridyl acetic acid Not more than 0.10%
c) 4-Pyridyl acetic acid Not more than 0.10%
d) Any Individual impurity Not more than 0.20%
e) Total impurities Not more than 1.0%
9 Assay 98.0 to102%w/w (On anhydrous basis).