Description

Tofacitinib Impurity 34 (CAS No. 2459302-86-2) is a high-purity chemical reference standard critical for the analytical profiling and quality control of the active pharmaceutical ingredient, Tofacitinib Citrate. This impurity is essential for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is primarily used by professionals in pharmaceutical development, quality assurance, and regulatory affairs who require reliable and well-characterized impurities for method validation and stability studies.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Tofacitinib Citrate drug substance and finished products.
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure they remain within International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Aids in the identification of degradation products formed during forced degradation and long-term stability testing of Tofacitinib formulations.
• Regulatory Submissions: Provides necessary data and characterization for regulatory filings (e.g., with FDA, EMA) to support drug approval and specification setting.
• Research & Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of this specific impurity.

Basic Information

Product Name	Tofacitinib Impurity 34
CAS No.	2459302-86-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tofacitinib Related Compound 34; Tofacitinib EP Impurity G; Tofacitinib USP Impurity; (3R,4R)-4-Methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)-β-oxo-1-piperidinepropanenitrile impurity; Xeljanz Impurity 34; CP-690550 Impurity 34
EINECS	Contact for details

Quality Control

Every batch of Tofacitinib Impurity 34 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced chromatographic and spectroscopic techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and other critical quality attributes.

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 anhydrous conditions. For long-term storage, consider storing under an inert atmosphere.

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

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