Description

Tacrolimus Impurity 18 is a designated impurity standard used in the pharmaceutical development and quality control of the immunosuppressant drug Tacrolimus. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Tacrolimus API (Active Pharmaceutical Ingredient) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to monitor impurities during the manufacturing process.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Tacrolimus meets stringent pharmacopeial purity specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Employed to track the formation of degradation products in Tacrolimus formulations under various storage conditions over time.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., with FDA, EMA) to support drug approval and market authorization.
• Research & Development (R&D): Used in synthetic chemistry research to understand the degradation pathways and metabolism of Tacrolimus.

Basic Information

Product Name	Tacrolimus Impurity 18
CAS No.	129039-81-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	23-Epi-Tacrolimus; 23-Epimer of Tacrolimus; FK506 Impurity 18; Tacrolimus Related Compound 18; (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
EINECS	Contact for details

Quality Control

Our Tacrolimus Impurity 18 is manufactured and tested under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical impurity analysis. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area.

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)	Meets internal specifications
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.