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ITEMS
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SPECIFICATION（BP 2009）
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TEST RESULT
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DESCRIPTION
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White or almost white or colourless,fine, silky needles, often in clusters
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Complies
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SOLUBILITY
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Soluble in water; soluble in ethanol (96%)
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Complies
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IDENTIFICATION
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(1)Thin-layer chromatography
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The principal spot in the chromatogram obtained with the test solution is similar in position, colour and size to that in the chromatogram obtained with the reference solution.
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Complies
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(2) Color response
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The solution gives a green colour .
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Complies
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(3)Ultraviolet absorption
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An intense blue fluorescence appears or disappears, accordant with response of quinine sulphate
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Complies
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(4) Chlorides Reaction
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It gives the reactions of chlorides.
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Complies
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TESTS
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(1) Appearance of solution
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Solution S is clear and not more intensely coloured than reference solution Y6
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Complies
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(2) pH
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6.0 to 6.8
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6.5
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(3)Specific
optical rotation
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- 245° to - 258°
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-255°
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(4) Other cinchona alkaloids
(HPLC)
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-- impurity C ≤10%
-- Any related substance eluting before quinine ≤ 5%
-- Any other related substance ≤ 2.5%.
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6.0%
3.5%
1.0%
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(5) Loss on drying
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3.0%to 5.0%
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3.5%
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(6) Sulphated ash
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≤0.1%
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Complies
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ASSAY（HPLC）
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99.0%-101.0%
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99.32%
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TEST CONCLUSION
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The product complies with BP2009 standards
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