Description

Tacrolimus Monohydrate 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 graft rejection and modulating immune responses with high efficacy. This high-purity active pharmaceutical ingredient (API) is essential for pharmaceutical manufacturers developing critical immunosuppressive therapies, including oral formulations and topical ointments for conditions like atopic dermatitis.

Application

• Immunosuppressive Drug Manufacturing: Primary API for oral capsules, tablets, and intravenous formulations used in post-organ transplant regimens.
• Topical Dermatological Treatments: Key ingredient in ointments and creams for managing moderate to severe atopic dermatitis (eczema).
• Autoimmune Disease Research: Critical reference standard and active component in preclinical and clinical research for autoimmune conditions.
• Pharmaceutical Reference Standards: Serves as a certified reference material (CRM) for quality control and analytical method development in pharmacopeial testing.
• Veterinary Medicine: Used in advanced veterinary care for managing immune-mediated diseases in companion animals.
• Drug Delivery System Development: Incorporated into novel delivery systems like nanoparticles and sustained-release formulations to improve bioavailability.

Basic Information

Product Name	Tacrolimus Monohydrate
CAS No.	109581-93-3
Molecular Formula	C44H69NO12 • H2O
Molecular Weight	822.03 g/mol (Monohydrate)
Synonyms	FK506 Monohydrate; Fujimycin Monohydrate; FR900506 Monohydrate; Prograf (API); Protopic (API); (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]oxazacyclotricosine-1,7,20,21(4H,23H)-tetrone Monohydrate
EINECS	Contact for details

Quality Control

Our Tacrolimus Monohydrate is manufactured under strict quality management systems, targeting compliance with major pharmacopeial standards including USP and EP. Each batch undergoes rigorous analytical testing for identity, purity, and potency. A comprehensive Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, water content, and microbial limits is provided to ensure traceability and regulatory compliance for pharmaceutical applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and potency. For long-term storage, consider desiccated conditions.

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% - 4.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Microbial Enumeration	Complies with USP <61> / Ph. Eur. 2.6.12
Specific Rotation	Contact for details

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