Description

Tacrolimus Impurity 13 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 and efficacy of the final drug product by enabling accurate identification, quantification, and control of this specific impurity during manufacturing. It is an essential tool for analytical laboratories, quality assurance teams, and research scientists in the pharmaceutical and biotechnology industries focused on generic drug development and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Tacrolimus Impurity 13 in active pharmaceutical ingredients (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating stability-indicating HPLC, UPLC, or LC-MS methods for Tacrolimus and related substances.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity profiles and ensure batches of Tacrolimus API meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to track the formation of this impurity under various stress conditions.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., ANDA, CMC sections) by providing definitive impurity characterization data for health authorities like the FDA and EMA.
• Research & Process Chemistry: Aids in understanding the degradation pathways and synthesis by-products of Tacrolimus, facilitating process optimization and impurity minimization strategies.

Basic Information

Product Name	Tacrolimus Impurity 13
CAS No.	1026775-21-2
Molecular Formula	C44H69NO12
Molecular Weight	804.0 g/mol
Synonyms	23-O-Demethyl Tacrolimus; 23-O-Desmethyl Tacrolimus; 23-O-Demethyl FK-506; 23-O-Desmethyl FK-506; FK-506 Impurity; Tacrolimus Related Compound; Tacrolimus Desmethyl Impurity; (1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-1,14-Dihydroxy-12-[(1E)-1-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]prop-1-en-2-yl]-23-methoxy-13,19,21,27-tetramethyl-17-(prop-2-en-1-yl)-11,28-dioxa-4-azatricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetrone
EINECS	Contact for details

Quality Control

Every batch of Tacrolimus Impurity 13 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, LC-MS, NMR) to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and related substances.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Assay (HPLC)	97.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 3.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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