Description

Tacrolimus Impurity 16 is a designated impurity of the potent immunosuppressant drug Tacrolimus, used in pharmaceutical research and development. This compound is critical for analytical method development, stability studies, and ensuring the quality and safety of the final drug product. It is an essential reference standard for quality control laboratories in the pharmaceutical industry, particularly those involved in the production and testing of immunosuppressive therapies.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Tacrolimus API and finished dosage forms.
• Critical component in analytical method development and validation (e.g., HPLC, UPLC) for Tacrolimus-related substances.
• Used in stability studies and forced degradation studies to understand the degradation pathways of Tacrolimus.
• Essential for quality control and assurance processes to meet regulatory requirements (ICH, USP, EP).
• Serves as a key material in research and development of Tacrolimus manufacturing processes and impurity profiling.
• Supports regulatory submissions by providing characterized impurity standards for drug master files (DMFs).

Basic Information

Product Name	Tacrolimus Impurity 16
CAS No.	135821-70-4
Molecular Formula	C44H69NO12
Molecular Weight	804.0 g/mol
Synonyms	23-Epi-Tacrolimus; 23-Epi-FK506; 23-Epimer of Tacrolimus; (1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-12-[(1E)-1,3-Dihydroxy-1-propen-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; FK506 Related Compound; Tacrolimus 23-Epimer; Tacrolimus EP Impurity G
EINECS	Contact for details

Quality Control

Our Tacrolimus Impurity 16 is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency, suitable for use as a reference standard. Each batch is fully characterized and undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing the results of all quality tests. The material is produced with a focus on meeting the stringent requirements of pharmaceutical R&D and QC laboratories.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C. The product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Single Unknown Impurity	≤ 1.0%
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.