Description

Tofacitinib Impurity 3 is a specified impurity and degradation product of the active pharmaceutical ingredient Tofacitinib Citrate. This compound is critical for pharmaceutical research, development, and quality control processes, serving as a reference standard for method validation and impurity profiling. It is essential for analytical chemists and quality assurance professionals in the pharmaceutical industry who require high-purity chemical reference materials to ensure drug safety and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Tofacitinib Citrate drug substance and finished products.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC/UPLC methods in accordance with ICH guidelines.
• Quality Control & Assurance: Employed in routine batch testing to monitor impurity levels and ensure drug product specifications are met.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Process Chemistry Research: Aids in understanding the formation pathway of this impurity during the synthesis of Tofacitinib, helping to optimize manufacturing processes.

Basic Information

Product Name	Tofacitinib Impurity 3
CAS No.	1206825-36-6
Molecular Formula	C16H20N6O
Molecular Weight	312.37 g/mol
Synonyms	(3R,4R)-4-Methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)-β-oxo-1-piperidinepropanenitrile; Tofacitinib Related Compound 3; Tofacitinib Degradant; CP-690550 Impurity 3; Xeljanz Impurity 3; (R)-4-Methyl-3-((methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)methyl)-2-oxopiperidine-1-carbonitrile
EINECS	Contact for details

Quality Control

Every batch of Tofacitinib Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatograms, and traceability information.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a cool, dry place. This material is hygroscopic (moisture-sensitive) and should be handled under dry, inert conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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