Description

Tacrolimus Ring-Opening Impurity is a critical pharmaceutical reference standard used for the quality control and analytical development of the immunosuppressant drug Tacrolimus. This impurity is essential for ensuring the purity, safety, and efficacy of the final drug product by enabling accurate identification and quantification during manufacturing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance of Tacrolimus-based formulations.

Application

• Primary use as a pharmaceutical reference standard for analytical method development and validation.
• Critical component in impurity profiling and stability studies of Tacrolimus API and drug products.
• Essential for quality control (QC) testing to monitor and control impurity levels in accordance with ICH guidelines.
• Used in regulatory submissions (e.g., for FDA, EMA) to establish impurity specifications.
• Valuable for research and development to understand degradation pathways of Tacrolimus.
• Supports pharmacopoeial testing to meet standards set by USP, EP, or other compendia.

Basic Information

Product Name	Tacrolimus Ring-Opening Impurity
CAS No.	1393890-33-9
Molecular Formula	C44H69NO12
Molecular Weight	804.01 g/mol
Synonyms	23,24,25,26,27-Pentanor-1,14-dihydroxy-12-[(1E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethenyl]-23-methoxy-2,16,20-trimethyl-8,26-epoxypyrido[2,1-g][1,7,19]trioxacyclopentacosin-3,21-dione; Tacrolimus Related Compound G; Tacrolimus Ring-Opened Impurity; FK506 Ring-Opening Impurity; (3S,4R,5S,8R,9E,12S,14S,15R,16S,18R,19R,26aS)-3-[(E)-2-Carboxyethenyl]-12,14-dihydroxy-5,8,16,18-tetramethyl-4,10,13,15,17,19,25-heptahydro-3H-pyrido[2,1-c][1,4]oxazacyclotricosine-1,7,20,21(4H,23H)-tetrone
EINECS	Contact for details

Quality Control

Our Tacrolimus Ring-Opening Impurity is manufactured under strict quality systems suitable for use as a pharmaceutical reference standard. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR, MS), to ensure compliance with stringent industry standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); ensure the container is kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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