Description

Tacrolimus Impurity 26 is a designated impurity of the potent immunosuppressant drug Tacrolimus, identified by CAS NO 104987-25-9. This compound is critical for pharmaceutical research and development, serving as a key reference standard for ensuring the purity, safety, and efficacy of Tacrolimus drug substances and products. It is primarily required by analytical laboratories and manufacturers engaged in the synthesis, quality control, and regulatory compliance of Tacrolimus formulations.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Tacrolimus API (Active Pharmaceutical Ingredient).
• Essential for method development and validation in analytical techniques such as HPLC and LC-MS.
• Critical component in stability studies to monitor degradation pathways and establish shelf-life for Tacrolimus-based drugs.
• Used in regulatory submissions to health authorities (e.g., FDA, EMA) to demonstrate comprehensive impurity profiling.
• Supports process chemistry research to optimize synthesis routes and minimize impurity formation.
• Valuable for academic and institutional research studying the metabolism and pharmacokinetics of Tacrolimus.

Basic Information

Product Name	Tacrolimus Impurity 26
CAS No.	104987-25-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	FK506 Impurity 26; 23-Epi-Tacrolimus; 23-Epimer of Tacrolimus; (23S)-Tacrolimus; Tacrolimus 23-Epimer; 23-Epi-FK506; Tacrolimus Related Compound 26
EINECS	Contact for details

Quality Control

Every batch of Tacrolimus Impurity 26 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards for pharmaceutical impurities and reference materials. Comprehensive characterization is performed using advanced analytical techniques. Certificates of Analysis (COA) detailing purity, identity, and impurity profile are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry conditions to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH guidelines

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