Description

Tofacitinib Impurity 2 CAS NO 1616760-97-4 is a specified impurity of the active pharmaceutical ingredient Tofacitinib, a Janus kinase (JAK) inhibitor. This compound is critical for pharmaceutical research and development, serving as a reference standard for analytical method development, validation, and quality control testing. 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 2 in drug substances and finished products.
• Analytical Method Development & Validation: Crucial for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles in accordance with ICH guidelines.
• Quality Control & Batch Release Testing: Used in routine QC laboratories to ensure Tofacitinib API and drug products meet stringent pharmacopeial (USP, EP) and internal purity specifications.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Process Chemistry Research: Aids in optimizing synthesis and purification processes to minimize the formation of this impurity during Tofacitinib manufacturing.

Basic Information

Product Name	Tofacitinib Impurity 2
CAS No.	1616760-97-4
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 2; Tofacitinib EP Impurity B; Tofacitinib USP Impurity 2; CP-690550 Impurity 2; (R)-3-((R)-4-Methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxopropanenitrile
EINECS	Contact for details

Quality Control

Our Tofacitinib Impurity 2 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity determination, residual solvent analysis (GC), and structural confirmation (NMR, MS). We provide full traceability and compliance with current Good Manufacturing Practice (cGMP) principles for reference standards. A detailed Certificate of Analysis (COA) with batch-specific data is supplied with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C, or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant use and storage under 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)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0%
Total Impurities	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
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.