Description

Cyclosporine is a potent, cyclic undecapeptide immunosuppressant widely recognized for its critical role in organ transplantation and autoimmune disease management. Its primary value lies in its selective inhibition of T-lymphocyte activation, providing effective immunosuppression with a reduced risk of broad-spectrum myelotoxicity. This makes it an essential active pharmaceutical ingredient (API) for pharmaceutical manufacturers developing formulations for transplant rejection prophylaxis and treatment of conditions like severe psoriasis, rheumatoid arthritis, and atopic dermatitis.

Application

• Immunosuppressive Drug Formulations: Primary API in oral solutions, soft gelatin capsules, and intravenous formulations for organ (kidney, liver, heart) transplant patients.
• Autoimmune Disease Therapeutics: Key component in medications for severe, recalcitrant plaque psoriasis, rheumatoid arthritis, and atopic dermatitis.
• Ophthalmic Emulsions: Used in topical eye drop formulations for the treatment of chronic dry eye disease by suppressing local inflammation.
• Veterinary Medicine: Employed in canine atopic dermatitis and other immune-mediated disorders in companion animals.
• Research & Development: Vital reference standard and tool compound in immunology, pharmacology, and transplant research laboratories.
• Drug Delivery System Development: Used in studies for novel delivery mechanisms like nanoparticles or micelles to improve bioavailability.

Basic Information

Product Name	Cyclosporine
CAS No.	63798-73-2
Molecular Formula	C62H111N11O12
Molecular Weight	1202.61 g/mol
Synonyms	Cyclosporin A; Ciclosporin; CsA; OL 27-400; Sandimmune; Cyclosporine A; Cyclosporin; [R-[R*,R*-(E)]]-Cyclic(L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl-3-hydroxy-N,4-dimethyl-L-2-amino-6-octenoyl-L-α-aminobutyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl)
EINECS	264-510-0

Quality Control

Our Cyclosporine is manufactured and tested under strict quality systems to meet the rigorous standards required for pharmaceutical active ingredients. We ensure compliance with relevant pharmacopoeial monographs (e.g., USP, EP, JP) and support regulatory filings. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing purity, identity, and impurity profiles as verified by advanced analytical techniques including HPLC, MS, and NMR.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C) or as specified on the label. The product is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to minimize exposure to atmospheric humidity.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
Specific Rotation	-185° to -195° (c=0.6 in methanol)

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.