Description

Tofacitinib Impurity CAS NO 2504210-41-5 is a high-purity chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient, Tofacitinib Citrate. This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure drug safety, efficacy, and regulatory compliance. It is primarily required by professionals in pharmaceutical R&D, quality assurance (QA), and quality control (QC) for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Tofacitinib Citrate drug substance and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods in accordance with ICH Q2(R1) guidelines.
• Quality Control & Batch Release: Employed in routine QC testing to monitor impurity levels and ensure batches meet stringent pharmacopeial (USP, EP) and internal specifications.
• Stability Studies: Used to track the formation and growth of this specific impurity during forced degradation and long-term stability studies of Tofacitinib, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., ANDA, NDA) with agencies like the US FDA and EMA.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Tofacitinib to minimize the formation of this impurity.

Basic Information

Item	Details
Product Name	Tofacitinib Impurity
CAS No.	2504210-41-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	3-((3R,4R)-4-Methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxopropanenitrile; Tofacitinib Related Compound; Tofacitinib Process Impurity; Tofacitinib Degradant; CP-690550 Impurity; Xeljanz Impurity; Janus Kinase (JAK) Inhibitor Impurity
EINECS	Contact for details

Quality Control

Every batch of Tofacitinib Impurity (CAS 2504210-41-5) is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including HPLC purity assay, related substance analysis, and structural confirmation (NMR, MS) to ensure identity, strength, and purity. A comprehensive Certificate of Analysis (CoA) is supplied with each lot, detailing all test results against predefined specifications.

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 compound is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity. Keep away from incompatible materials.

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)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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