Description

Tofacitinib Impurity 5 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient, Tofacitinib Citrate. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies for the Janus kinase (JAK) inhibitor drug substance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Tofacitinib Citrate.
• Method Development & Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to separate and quantify impurities.
• Quality Control (QC) Testing: Used in routine batch release testing of Tofacitinib API to monitor and control impurity levels as per ICH guidelines.
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs).
• Research on Degradation Pathways: Aids in understanding the chemical stability and degradation mechanisms of Tofacitinib.

Basic Information

Product Name	Tofacitinib Impurity 5
CAS No.	2250243-18-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tofacitinib Related Compound 5; Tofacitinib EP Impurity 5; Tofacitinib USP Impurity 5; Tofacitinib Degradant 5; (3R,4R)-4-Methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)-β-oxo-1-piperidinepropanenitrile; CP-690550 Impurity 5; Xeljanz Impurity 5.
EINECS	Contact for details

Quality Control

Our Tofacitinib Impurity 5 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity determination and structural confirmation (e.g., by NMR and MS), to ensure it meets the high standards required for use as a reference material. Certificates of Analysis (COA) with detailed chromatographic data, batch-specific results, and traceability are provided to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies
Residual Solvents (GC)	Complies with ICH Q3C

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