Description

Tofacitinib Related Compound CAS NO 1206824-85-2 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical products by serving as a benchmark in impurity profiling and method validation. It is primarily needed by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in the development and quality control of Janus kinase (JAK) inhibitor drugs.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material to identify and quantify related substances in Tofacitinib Citrate active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and LC-MS methods to ensure regulatory compliance.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within pharmaceutical QC laboratories to monitor impurity levels against ICH guidelines.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to understand drug product behavior.
• Research & Development: Utilized in academic and industrial R&D for studying the metabolism, pharmacokinetics, and degradation pathways of JAK inhibitors.

Basic Information

Product Name	Tofacitinib Related Compound CAS NO 1206824-85-2
CAS No.	1206824-85-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tofacitinib Impurity; Tofacitinib Related Substance; Tofacitinib Degradant; CP-690550 Related Compound; (3R,4R)-4-Methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)-β-oxo-1-piperidinepropanenitrile; JAK Inhibitor Impurity; Tofacitinib Citrate Impurity
EINECS	Contact for details

Quality Control

Our Tofacitinib Related Compound is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment, supporting compliance with ICH Q3A/B and current Good Manufacturing Practice (cGMP) principles.

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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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