Description

8-Epitacrolimus is a significant chemical intermediate and a key stereoisomer of the potent immunosuppressant Tacrolimus. Its precise chemical structure makes it an essential reference standard and building block in advanced pharmaceutical research and development. This compound is primarily utilized by researchers and manufacturers in the pharmaceutical and biotechnology sectors for the synthesis, quality control, and metabolic studies of immunosuppressive agents.

Application

• Pharmaceutical Reference Standard: Used as a high-purity analytical standard for the identification and quantification of Tacrolimus and its related substances in drug substances and products.
• Active Pharmaceutical Ingredient (API) Synthesis: Serves as a critical intermediate in the complex synthetic pathways for producing immunosuppressant drugs.
• Metabolite Research: Employed in pharmacological and toxicological studies to understand the metabolism and pharmacokinetics of Tacrolimus-related compounds.
• Process Development & Validation: Essential for developing and validating robust analytical methods (e.g., HPLC, LC-MS) in pharmaceutical manufacturing.
• Impurity Profiling: Used to identify, characterize, and control isomeric impurities in bulk Tacrolimus to ensure final product safety and efficacy.
• Biochemical Research: Applied in molecular biology and immunology research to study calcineurin inhibition and T-cell activation pathways.

Basic Information

Product Name	8-Epitacrolimus
CAS No.	129212-35-7
Molecular Formula	C44H69NO12
Molecular Weight	804.0 g/mol
Synonyms	8-Epi Tacrolimus; 8-Epi-FK506; 8-Epimer of Tacrolimus; 8-Epimer of FK-506; (1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-12-[(E)-2-[(1R,3R,4R)-4-Hydroxy-3-methoxycyclohexyl]-1-methylvinyl]-17-ethyl-1,14-dihydroxy-23,25-dimethoxy-13,19,21,27-tetramethyl-11,28-dioxa-4-azatricyclo[22.3.1.0⁴,⁹]octacos-18-ene-2,3,10,16-tetrone
EINECS	Contact for details

Quality Control

Our 8-Epitacrolimus is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, chiral analysis for isomeric content, and spectroscopic identification (IR, NMR, MS) to confirm structure and identity. We provide a detailed Certificate of Analysis (COA) with every shipment, ensuring traceability and compliance with research-grade specifications. Our quality commitment supports applications requiring high-purity reference materials and pharmaceutical intermediates.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
8-Epitacrolimus Content (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity ≤ 1.0%; Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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