Description

Tofacitinib Impurity 40 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Tofacitinib Citrate. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by enabling accurate identification and quantification of process-related impurities. It is an essential tool for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs departments involved in the development and manufacturing of Janus kinase (JAK) inhibitor therapies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Tofacitinib Impurity 40 in API and finished drug products.
• Method Development and Validation: Critical for developing, optimizing, and validating stability-indicating analytical methods, such as HPLC and UPLC.
• Quality Control and Batch Release: Used in routine QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines to ensure batch-to-batch consistency.
• Stability Studies: Employed in forced degradation and long-term stability studies to track impurity formation pathways and establish shelf-life.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Process Chemistry Research: Aids in understanding and optimizing synthetic pathways to minimize the formation of this specific impurity during API manufacturing.

Basic Information

Product Name	Tofacitinib Impurity 40
CAS No.	2315287-12-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tofacitinib Related Compound 40; Tofacitinib Citrate Impurity 40; CP-690550 Impurity 40; Xeljanz Impurity 40; (3R,4R)-4-Methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)-β-oxo-1-piperidinepropanenitrile Impurity; Tofacitinib Process Impurity; JAK Inhibitor Impurity
EINECS	Contact for details

Quality Control

Our Tofacitinib Impurity 40 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, MS), and residual solvent analysis, to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is supplied with every shipment, detailing batch-specific results and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.