Injectable grade ,EP6.0. white powder,moderately hygroscopic , freely soluble in water.
EP6.0 or BP2008.Origin: porcine intestinal mucosa
Appearance: white powder.
specifications:
EP6.0 or BP2008.Origin: porcine intestinal mucosa
Appearance: white powder.
specifications:
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Origin
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Healthy porcine intestinal mucosa
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Characters
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A white or almost white moderately hygroscopic powder, freely soluble in water
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Identification Item A
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Delay the clotting of blood
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Identification Item B
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Specific optical rotation: more than
+ 35 degree
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Identification Item C
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Agarose-gel electrophoresis:0.9 - 1.1
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Identification Item D
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Positive sodium reaction
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Appearance of solution
(5000 IU/ml heparin sodium)
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Clarity: clear
Colour: not more intensely coloured than BY5
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pH(1% w/v solution)
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5.5 – 8.0
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Protein and nucleotidic impurities
(0.4 % w/v)
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O.D.:Less than 0.200 at 260 nm
O.D.:Less than 0.150 at 280 nm
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Nitrogen
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Not more than 2.5 %
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Sodium
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9.5 - 12.5 %
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Heavy metals
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Less than 30 ppm
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Loss on drying
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Less than / equal to 5.0 %
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Sulfated ash
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30 - 43 %
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Assay
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More than 175I.U./mg
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Residual solvents
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Less than 5000ppm
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Microorganism
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Total viable aerobic count
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Bacteria:Less than 10 C.F.U./g
Yeasts and moulds:Less than 10 C.F.U./g
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Specific micro-organism
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Escherichia. Coli: not detected/g
Pseudomonas Aeruginosa: not detected/g
Staphylococcus Aureus: not detected/g
Bile-tolerant Gram-negative bacteria: not detected/g
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Over-sulfated chondroitin sulfate
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Capillary electrophoresis
H-NMR
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The electropherogram of test solution does not exhibit a sharp distinguishable peak in front of the main heparin peak
No peak should be visible at 2.16±0.03ppm
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