Test
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Specifications
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Description
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White to off white powder.
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Solubility
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Soluble in Methylene chloride, sparingly soluble in methanol and in ethanol. Very slightly soluble in water.
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Identification
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- The spectrum of sample should match with that of standard.
- The sample spot should correspond with that of standard.
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Loss on drying (At 60oC under vacuum for 4 hrs. % w/w)
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Not more than 0.20% w/w
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Sulfated ash (% w/w)
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Not more than 0.10% w/w
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Impurity by TLC (Impurity C)
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Not more than 0.10%
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Melting Range
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Between 150o C and 160o C
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Color of solution
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Maximum 0.1A at 440 nm
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Assay by titrimetry (% w/w, on dried basis)
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Between 99.0% and 101.0% w/w
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Purity by HPLC
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Not less than 99.5%
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Related substances by HPLC Individual Impurity
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Not more than 0.1%
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