Description

Tofacitinib Impurity 20 is a specified impurity of the active pharmaceutical ingredient (API) Tofacitinib Citrate, a Janus kinase (JAK) inhibitor. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is essential for manufacturers, analytical laboratories, and regulatory bodies involved in ensuring the purity, safety, and efficacy of Tofacitinib-based drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Tofacitinib Impurity 20 in drug substance and drug product.
• Analytical Method Development: Crucial for developing and optimizing chromatographic methods (HPLC, UPLC) to separate and detect this specific impurity.
• Quality Control & Assurance: Used in routine batch testing to monitor impurity levels and ensure compliance with International Council for Harmonisation (ICH) guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: Employed to track the formation of this impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity profiling and control strategy.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Tofacitinib to minimize the formation of this impurity.

Basic Information

Product Name	Tofacitinib Impurity 20
CAS No.	1092578-44-3
Molecular Formula	C16H20N6O
Molecular Weight	312.37 g/mol
Synonyms	CP-690550 Impurity 20; (3R,4R)-4-Methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)-β-oxo-1-piperidinepropanenitrile; Tofacitinib Related Compound 20; Tofacitinib Citrate Impurity 20; Xeljanz Impurity 20; 1-Piperidinepropanenitrile, 4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)-β-oxo-, (3R,4R)-
EINECS	Contact for details

Quality Control

Every batch of Tofacitinib Impurity 20 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, GC, MS, and NMR to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting its use in GMP/GLP environments and regulatory submissions.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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