Description

Tacrolimus Impurity 3 is a specified impurity of the potent immunosuppressant drug Tacrolimus, identified by CAS No. 161861-10-5. This compound is critical for pharmaceutical research and development, serving as a key reference standard for ensuring the purity, safety, and efficacy of Tacrolimus API and its formulations. It is primarily required by analytical laboratories and manufacturers in the pharmaceutical industry for method development, validation, and rigorous quality control testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Tacrolimus drug substance and products.
• Analytical Method Development: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Assurance: A critical component in batch release testing to ensure compliance with pharmacopeial monographs (e.g., USP, EP, JP) and ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions to establish shelf life.
• Regulatory Submissions: Provides necessary impurity data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Used to study and optimize the synthesis pathway of Tacrolimus to minimize the formation of this specific impurity.

Basic Information

Product Name	Tacrolimus Impurity 3
CAS No.	161861-10-5
Molecular Formula	C44H69NO12
Molecular Weight	804.0 g/mol
Synonyms	FK506 Impurity 3; 23-Epi Tacrolimus; 23-Epimer of Tacrolimus; (1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-12-[(1E)-1-[(1R,3R,4R)-4-Hydroxy-3-methoxycyclohexyl]prop-1-en-2-yl]-17-ethyl-1,14-dihydroxy-23-methoxy-13,19,21,27-tetramethyl-11,28-dioxa-4-azatricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetrone; Tacrolimus Related Compound C; FR900506 Impurity C
EINECS	Contact for details

Quality Control

Every batch of Tacrolimus Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA), detailing results from HPLC, NMR, and MS analyses, is provided with each shipment to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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