Description

Tofacitinib Impurity 1 is a designated impurity of the active pharmaceutical ingredient Tofacitinib, a Janus kinase (JAK) inhibitor. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, quality control, and regulatory compliance. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the synthesis, purification, and quality assurance of Tofacitinib drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Tofacitinib active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure Tofacitinib products meet stringent pharmacopeial (USP, EP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Used to track the formation and levels of this specific impurity during forced degradation and long-term stability testing of drug products.
• Regulatory Submissions: Critical for preparing regulatory documentation (e.g., CMC sections for FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Process Chemistry Research: Aids in understanding and optimizing the Tofacitinib synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Tofacitinib Impurity 1
CAS No.	2106832-55-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tofacitinib Related Compound 1; Tofacitinib Impurity A; (3R,4R)-4-Methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)-β-oxo-1-piperidinepropanenitrile; CP-690550 Impurity 1; Xeljanz Impurity 1
EINECS	Contact for details

Quality Control

Our Tofacitinib Impurity 1 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and traceability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques such as HPLC, NMR, and MS. We ensure compliance with relevant standards for pharmaceutical reference materials, supporting your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (typically 15-25°C) or as specified on the Certificate of Analysis. The material should be kept in a dry environment to prevent moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual 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.