Customization: | Available |
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Powder: | Yes |
Customized: | Customized |
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Items
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Requirements
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Results
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Appearance:
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White crystals or a white, crystalline powder
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White crystals or a white, crystalline powder.
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Melting point
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132°C~135°C
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133°C
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Optical rotation
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+10°~+14°
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+13.5°
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Identification
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(1) Color Reaction
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Should be positive
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positive
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(2) Color Reaction
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Should be positive
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positive
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(3) TLC
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The principal spot obtained with test solution corresponds in position, appearance, and intensity with that obtained from reference solution. |
Conforms
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(4) IR
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The infrared absorption spectrum is concordant with the spectrum obtained from Artesunate RS or with the reference spectrum of artesunate. |
Conforms
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Test
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(1) Acidity
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3.5~5.0
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4.5
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(2)Solution transparency and color
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Meet the requirements
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Conforms
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(3) Chlorides
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Meet the requirements
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Conforms
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(4)related substance
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Just the principal spot can be shown compared with reference, and no other impurity spots are exhibited.
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Conforms
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(5) Moisture content
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≤0.5%
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0.003
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(6) Residual on Ignition
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≤ 0.1%
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0.0006
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(7) Heavy metal
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Meet the requirements
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Conforms
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Assay (on dry basis)
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98.0% ~102.0%(HPLC)
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0.9957
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Conclusion
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The product conforms with CP2010
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