Customization: | Available |
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CAS No.: | 84-80-0 |
Formula: | C31h46o2 |
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Vitamin K1, also known as phytomenadione, chloromenadione, chloroquinone, chemically known as 2-methyl-3-phytyl-1, 4-naphthoquinone, is a polycyclic aromatic ketone, a fat-soluble vitamin that is stable to air and humidity, but is broken down in sunlight. It is widely found in natural green plants. Vitamin K1 is a vitamin drug, which is a necessary substance for liver synthesis of factors II, VII, IX and X. Vitamin K1 injection is the 2009 edition of the national Essential Medicine list variety, mainly used for the treatment of hemorrhagic diseases caused by vitamin K deficiency. In December 2011, the State Food and Drug Administration notified that vitamin K1 injection had a risk of allergy. |
Analysis
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Specification
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Result
|
Test method
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Physical Description
|
|
|
|
Appearance
|
Light yellow powder | Light yellow powder |
Visual
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Odor
|
Characteristic
|
Characteristic
|
Organoleptic
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Particle size
|
90% pass 80 mesh
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90% pass 80 mesh
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80 Mesh Screen
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Chemical Tests
|
|
|
|
Assay (Lutein)
|
5%
|
5.03%
|
HPLC
|
Loss on drying
|
5.0% Max
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1.35%
|
5g/105ºC/2hrs
|
Ash Contents
|
5.0% Max
|
1.20%
|
2g/525ºC/3hrs
|
Residual Solvents
|
50.0 ppm, Only Ethanol
|
<30.0 ppm
|
/
|
Heavy metals
|
5.0 ppm Max
|
<3.0 ppm
|
AAS
|
Lead
|
3.0 ppm Max
|
<1.0 ppm
|
AAS
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Arsenic
|
3.0 ppm Max
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<1.0 ppm
|
AAS
|
Microbiology Control
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|
|
|
Total Bacteria Count
|
1,000cfu/g Max
|
<280cfu/g
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AOAC
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Yeast & Mold
|
100cfu/g Max
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<10cfu/g
|
AOAC
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Coliform
|
30.0 MPN/g Max
|
<3.0 MPN/g
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AOAC
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Conclusion
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Complies with the standards.
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General Status
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ISO Certificated.
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