Description

Tacrolimus Hydroxy Acid Impurity is a key process-related degradant and metabolite of the potent immunosuppressant drug Tacrolimus. This high-purity reference standard is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of this specific impurity during drug substance manufacturing. It is an essential material for analytical method development, validation, and stability studies to ensure product safety and regulatory compliance. This compound is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and quality control laboratories focused on generic and innovator immunosuppressive therapies.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the qualitative and quantitative analysis of Tacrolimus and its related substances in compliance with ICH Q3A/B guidelines.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, and LC-MS/MS methods for impurity profiling and assay determination.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to monitor the formation of this specific hydroxy acid degradant in Tacrolimus drug substance and finished products.
• Quality Control & Batch Release: Acts as a system suitability and identification standard in the routine QC testing of Tacrolimus Active Pharmaceutical Ingredient (API) to ensure impurity levels meet pharmacopeial specifications.
• Metabolite Research: Used in preclinical and clinical studies to understand the metabolic pathways and pharmacokinetics of Tacrolimus.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).

Basic Information

Item	Details
Product Name	Tacrolimus Hydroxy Acid Impurity
CAS No.	1700657-83-5
Molecular Formula	C44H69NO13
Molecular Weight	820.0 g/mol (approximately)
Synonyms	23-Hydroxy Tacrolimus; 23-OH Tacrolimus; Tacrolimus 23-Hydroxy Acid; 23-Hydroxy FK506; FK506 Hydroxy Acid; (1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-12-[(1E)-1,3-Dihydroxybut-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; 23-O-Demethyl Tacrolimus Hydroxy Acid
EINECS	Contact for details

Quality Control

Every batch of our Tacrolimus Hydroxy Acid Impurity is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques including HPLC, LC-MS, and NMR to ensure it meets the high standards required for pharmaceutical impurity reference standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with ICH, USP, and EP guidelines for impurities in new drug 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 compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
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.