| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Customized |
|
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| Tacrolimus (Astagraf XL, Envarsus XR, Prograf) is used along with other medications to prevent rejection (attack of a transplanted organ by the immune system of a person receiving the organ) in people who have received a kidney transplant. Tacrolimus (Prograf) is also used along with other medications to prevent rejection in people who have received a liver, lung, or heart transplant. Tacrolimus is in a class of medications called immunosupressants. It works by decreasing the activity of the immune system to prevent it from attacking the transplanted organ. |
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Analysis
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Specification
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Result
|
Test method
|
|
Physical Description
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|
|
|
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Appearance
|
Red Powder
|
Red Powder |
Visual
|
|
Odor
|
Characteristic
|
Characteristic
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Organoleptic
|
|
Particle size
|
90% pass 80 mesh
|
90% pass 80 mesh
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80 Mesh Screen
|
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Chemical Tests
|
|
|
|
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Assay (Lutein)
|
99%
|
90.15%
|
HPLC
|
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Loss on drying
|
5.0% Max
|
1.82%
|
5g/105ºC/2hrs
|
|
Ash Contents
|
5.0% Max
|
1.12%
|
2g/525ºC/3hrs
|
|
Residual Solvents
|
50.0 ppm, Only Ethanol
|
<30.0 ppm
|
/
|
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Heavy metals
|
5.0 ppm Max
|
<3.0 ppm
|
AAS
|
|
Lead
|
3.0 ppm Max
|
<1.0 ppm
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AAS
|
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Arsenic
|
3.0 ppm Max
|
<1.0 ppm
|
AAS
|
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Microbiology Control
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|
|
|
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Total Bacteria Count
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1,000cfu/g Max
|
<280cfu/g
|
AOAC
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Yeast & Mold
|
100cfu/g Max
|
<10cfu/g
|
AOAC
|
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Coliform
|
30.0 MPN/g Max
|
<3.0 MPN/g
|
AOAC
|
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Conclusion
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Complies with the standards.
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||
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General Status
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Non-GMO, ISO Certificated.
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