SHANGHAI FINE CHEMICALS CO., LTD.
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Items of Test
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Limits of Test
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Results of Test
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1.Appearance
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Orange yellow crystalline powder
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Meets
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2.Identification
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A: Optical rotation -115º to -135º
B: TLC test
C: Test of fluorescence
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A: Value
B,C: Meets
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3.Acidity or Alkalinity
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check the color of the test solution after adding the respective solutions
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Meets
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4.Lumiflavin
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TLC NMT 0.025%
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Meets
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5.Absorbance
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0.31-0.33 A373nm/A267nm
0.36-0.39 A444nm/A267nm
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Meets
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6.Particla Size
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100% passes through 80 mesh sieve
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Meets
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7.Specific Rotation
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between-115º and -135º
(EP/BP/USP)
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-124º
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8.Loss on Drying
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≤1.5%
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0.5%
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9.Heavy Metals
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<10ppm
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Meets
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10.Residue on Ignition
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≤0.3% (USP)
≤0.1%(EP/BP)
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0.1%
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11.Organic Volatile
Impurities
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Method IV <467>
(USP)
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Meets
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12.Assay(ondried basis)
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98.0%-102.0% (USP)
97.0%-103.0% (EP/BP)
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98.4%
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testig items specification result
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Colour
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Yellow-orange to yellow-brown
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Meets
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Odour
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weak to none
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Meets
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Particle structure
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fine spray-dried granules
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Meets
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Identification
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Positive
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Meets
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Particle size
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60 U.S
mesh(MIN.90% PASSED)
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Meets
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Residue on Ignition
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Max.5%
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3%
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Humidity
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Max.3.0%
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1.9%
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Content(Activity)
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Min.80.0%
(by HPLC Method)
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80.5%
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CONCLUSION: THIS PRODUCT FULFILS THE STANDARDS.
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