Description

Tofacitinib Impurity 44 is a high-purity chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient, Tofacitinib. This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Tofacitinib API batches.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, and LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): A key component in routine quality control testing to ensure Tofacitinib meets stringent pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Employed to track the formation and levels of this specific degradation product under various stress conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Tofacitinib to minimize impurity formation.

Basic Information

Product Name	Tofacitinib Impurity 44
CAS No.	2374700-39-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tofacitinib Related Compound 44; Tofacitinib EP Impurity J; Tofacitinib USP Impurity; Xeljanz Impurity 44; CP-690550 Impurity 44; (3R,4R)-4-Methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)-β-oxo-1-piperidinepropanenitrile Impurity; Tofacitinib Degradation Product
EINECS	Contact for details

Quality Control

Every batch of Tofacitinib Impurity 44 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, LC-MS, NMR) to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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