Description

Tacrolimus CAS NO 104987-11-3 is a potent macrolide immunosuppressant widely used in organ transplantation and autoimmune disease management. Its primary value lies in its ability to selectively inhibit T-cell activation, preventing organ rejection and modulating immune responses with high efficacy. This active pharmaceutical ingredient (API) is essential for pharmaceutical manufacturers developing critical immunosuppressive therapies. Key industries requiring this compound include the pharmaceutical, biotechnology, and advanced research sectors.

Application

• Primary Immunosuppression in Organ Transplantation: Formulated into capsules, tablets, and injections for preventing rejection in kidney, liver, and heart transplant patients.
• Treatment of Autoimmune Disorders: Used in topical formulations for conditions like atopic dermatitis and psoriasis, and systemically for other immune-mediated diseases.
• Pharmaceutical Research & Development (R&D): Serves as a reference standard and key intermediate in developing novel immunosuppressive drugs and combination therapies.
• Generic Drug Manufacturing: A critical API for producing generic versions of tacrolimus-based medications, ensuring wider patient access.
• Clinical Trial Material (CTM): Supplied under GMP conditions for use in clinical studies evaluating new indications or formulations.
• Biochemical Research: Utilized in laboratory studies to investigate T-cell biology, calcineurin inhibition pathways, and immune system modulation.

Basic Information

Product Name	Tacrolimus
CAS No.	104987-11-3
Molecular Formula	C44H69NO12
Molecular Weight	804.02 g/mol
Synonyms	FK-506; Fujimycin; Prograf (trade name); Protopic (trade name); Advagraf (trade name); Envarsus XR (trade name); (3S,4R,5S,8R,9E,12S,14S,15R,16S,18R,19R,26aS)-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-Hexadecahydro-5,19-dihydroxy-3-[(E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylvinyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone
EINECS	Contact for details

Quality Control

Our Tacrolimus is manufactured under strict quality systems, with specifications designed to meet or exceed major pharmacopoeial standards such as USP and EP. Each batch undergoes comprehensive analytical testing including HPLC for assay and impurity profiling, identification by spectroscopic methods, and tests for residual solvents and heavy metals. A Certificate of Analysis (COA) documenting full compliance is provided with every shipment, and we support regulatory filings with comprehensive DMF support.

Storage

Preserve in a tightly closed container, protected from light. Store under an inert atmosphere (e.g., nitrogen) at a controlled room temperature of 15-25°C (59-77°F) to minimize oxidation and ensure long-term stability. The container should be kept in a cool, dry, and well-ventilated area, away from incompatible materials.

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)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual impurity: ≤ 0.5%; Total impurities: ≤ 2.0%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Specific Rotation	-84.0° to -90.0° (c=1, CHCl3)

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