Description

Tacrolimus Open Ring Impurity is a key chemical reference standard used in the pharmaceutical development and quality control of the potent immunosuppressant drug Tacrolimus. This impurity is critical for ensuring the purity, safety, and efficacy of the final drug product by enabling accurate identification and quantification during analytical testing. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and manufacturers of active pharmaceutical ingredients (APIs) who require high-purity reference compounds for method validation and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material (CRM) for the identification and quantification of the open-ring derivative in Tacrolimus API and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods for impurity analysis.
• Stability Studies and Forced Degradation Testing: Employed to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Quality Control and Batch Release Testing: Essential for setting specification limits and ensuring batch-to-batch consistency of Tacrolimus in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Pharmacopoeial Standards: Supports testing against monographs in pharmacopoeias such as USP, EP, and JP where impurity specifications are defined.

Basic Information

Product Name	Tacrolimus Open Ring Impurity
CAS No.	144432-23-5
Molecular Formula	C44H69NO12
Molecular Weight	804.0 g/mol
Synonyms	23-Desmethoxy Tacrolimus; 23-Demethoxy Tacrolimus; Open Ring Tacrolimus; Tacrolimus Related Compound C; Tacrolimus Impurity C; FR-900523 Open Ring Derivative; (3S,4R,5S,8R,9E,12S,14S,15R,16S,18R,19R,26aS)-8-Ethenyl-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxazacyclotricosine-1,7,20,21(4H,23H)-tetrone
EINECS	Contact for details

Quality Control

Our Tacrolimus Open Ring Impurity is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques including NMR, MS, and HPLC to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing the results for identity, assay, purity, and related substances. We support compliance with ICH guidelines and can supply materials suitable for use in GMP-regulated environments.

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. This compound is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

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%
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% 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.