Description

Tacrolimus Impurity 5 CAS NO 161861-18-3 is a specified impurity of the potent immunosuppressant drug Tacrolimus. This compound is critical for pharmaceutical research and development, serving as a key reference standard for quality control and regulatory compliance. It is primarily required by analytical laboratories and pharmaceutical manufacturers engaged in the synthesis, purification, and validation of Tacrolimus API and its related drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Tacrolimus active pharmaceutical ingredient (API) and finished formulations.
• Method Development & Validation: Essential for developing and validating analytical methods, such as HPLC and LC-MS, to ensure specificity, accuracy, and precision in impurity profiling.
• Quality Control & Assurance: A critical component in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency, meeting pharmacopeial standards (USP, EP, ICH).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs) and marketing authorization applications.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions, helping to establish product shelf-life and storage recommendations.
• Process Chemistry Research: Used by chemists to study and optimize the Tacrolimus synthesis pathway, aiming to minimize the formation of this specific impurity.

Basic Information

Product Name	Tacrolimus Impurity 5
CAS No.	161861-18-3
Molecular Formula	C44H69NO12
Molecular Weight	804.02 g/mol
Synonyms	FK506 Impurity 5; 32-Epi-Tacrolimus; 32-Epi-FK506; (1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-12-[(1E)-1-[(1R,3R,4R)-4-[(2R,5S,6S)-5-Ethyl-5,6-dihydroxy-6-methyltetrahydro-2H-pyran-2-yl]-3-methoxycyclohexyl]prop-1-en-2-yl]-17-ethyl-1,14-dihydroxy-23,25-dimethoxy-13,19,21,27-tetramethyl-11,28-dioxa-4-azatricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetrone; Tacrolimus Related Compound E; 32-Epimer of Tacrolimus
EINECS	Contact for details

Quality Control

Every batch of Tacrolimus Impurity 5 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing all analytical results. Our quality processes are designed to support compliance with ICH Q3A, Q3B, USP, and EP guidelines.

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 material is hygroscopic (moisture-sensitive) and must be kept under dry conditions to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

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%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
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.