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HPLC Ciclosporin Api Intermediates Immunosuppressant Drug CAS 59865-13-3

Categories Active Pharmaceutical Ingredient
Brand Name: VANZ
Model Number: 59865-13-3
Certification: ISO9001
Place of Origin: China
MOQ: 10g
Price: USD2.5-5 Per Gram
Payment Terms: Western Union, MoneyGram, T/T
Supply Ability: 25kg per month
Delivery Time: 2-5 days
Packaging Details: aluminum foils bags or drum or gegotiation
CAS: 59865-13-3
Appearance: White powder
Bioavailability: Oral
Biological half-life: Variable (about 24 hours)
Synonyms: cyclosporine, cyclosporin, ciclosporin A,cyclosporine A, cyclosporin A(CsA)
COA: Available
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Wuhan Vanz Pharm Inc.
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HPLC Ciclosporin Api Intermediates Immunosuppressant Drug CAS 59865-13-3

HPLC Ciclosporin Api Intermediates Immunosuppressant Drug CAS 59865-13-3


Basic Information


Ciclosporin
CAS:59865-13-3
Specification:CP, EP, USP
Purity:min.99%
Packing: 25kg/drum or customized requirement
Usage: An immunosuppressant that has revolutionized organ transplantation through its use in the prevention of graft rejection. A group of nonpolar cyclic oligopeptides with immunosupppressant activity.


Introduction


Ciclosporin, also spelled cyclosporine, is an immunosuppressant drug widely used in organ transplantation to prevent rejection. It reduces the activity of the immune system by interfering with the activity and growth of T cells.


It was initially isolated from the fungus Tolypocladium inflatum found in a soil samples in 1969 from Norway, by Hans Peter Frey. Most ptptides are synthesized by ribosomes, but ciclosporin is a cyclic nonribosomal peptide of 11 amino acids and contains a single D-amino acid, which is rarely encountered in nature.


Ciclosporin was discovered in 1976. It is on the WHO Model List of Essential Medicine, the most important medications needed in a basic health system.


Certificate of Analysis


Product: CYCLOSPORINE(USP36)Batch No:FM20160618
Quantity: 50kgReport Date:June.26,2016
Mfg.Date: June.18,2016Exp.Date:May.2020
RESULTS OF EXAMINATION
Test ItemsSpecificationResults
AppearanceWhite crystalline powderWhite crystalline powder
SolubilityTo complyComplies
IdentificationTo complyComplies
Loss on dying2.0%max0.6%
Heavy metals0.002%max<0.002%
Related compounds
1.individual impurity0.7%max0.3%
2 sum of all impurity1.5%max1.1%
Any other impurity0.1%max0.07%
Residual solvents
Acetone0.5%max0.02%
Ethanol0.5%max0.00%
Ethyl acetate0.5%max0.04%
ASSAY98.5%~101.5%99.3%
CONCLUSION: Product complies with USP36 Standard.

Medical uses


Ciclosporin is approved by the FDA to prevent and treat graft-versus-host disease in bone-marrow transplantation and to prevent rejection of kidney, heart, and liver transplants.It is also approved in the US for the treatment of rheumatoid arthritis and psoriasis, as an ophthalmic emulsion for the treatment of dry eyes (a common symptom of Sjögren's syndrome), and as a treatment for persistent nummular keratitis following adenoviral keratoconjunctivitis.


Adverse effects


  • Treatment may be associated with a number of potentially serious adverse drug reactions (ADRs).
  • Use of cyclosporin in post renal transplantation is associated with hyperuricemia and, in some cases, gout. This is due to the decrease in glomerular filtration rate induced by cyclosporin leading to retention of uric acid. Use of azathioprine as an alternative has shown to reduce the incidence of gouty arthritis.
  • An alternate form of the drug, cyclosporin G (OG37-324), has been found to be much less nephrotoxic than the standard ciclosporin (cyclosporin A).

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