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Tramadol Hydrochloride EP
Test
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Specification
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Appearance
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White, crystalline powder
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Solubility
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Freely soluble in water and methanol Very slightly solution in Acetone.
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Identification
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IR Spectrum is concordant with working reference standard.
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180o - 184oC.
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- Chromatograms obtained in the test for impurity E
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The principle spot in the chromatograph obtained with the test solution (b) is similar position and size to the principle spot in the chromatogram obtained with reference solution. (a)
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It gives the reaction of chlorides.
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Appearance of solution
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The solution should be clear and colorless.
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Acidity
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NMT 0.4ml of 0.01M Sodium Hydroxide is Required to change the color of solution to Yellow.
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Optical Rotation
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-0.10o to +0.10o (5.0% w/v in water)
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Impurity E - By TLC
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IN the chromatogram obtained with reference solution (a), any spot corresponding to impurity E is not intense ant not greater than the spot in the chromatogram obtained with reference solution (b) (0.20%)
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Related substances By HPLC
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Not more than 0.20%
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Not more than 0.10% |
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Not more than 0.40% |
Water content
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Not more than 0.50% w/w |
Sulphated Ash
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Not more than 0.10% w/w |
Heavy Metals
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Not more than 20 PPM
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Assay (by chemical)
(On anhydrous substance)
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Not less than 99.0% w/w and
Not more than 101.0% w/w
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Remarks: This product confirms to EP Specifications.
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