Description

Tofacitinib Impurity K is a designated impurity of the active pharmaceutical ingredient (API) 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, stability studies, and quality control. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Tofacitinib-based drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Tofacitinib Impurity K in API and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Stability and Forced Degradation Studies: Used to understand the degradation pathways of Tofacitinib and establish appropriate storage conditions and shelf life.
• Quality Control & Batch Release Testing: Enables precise impurity profiling to ensure drug substance and product meet stringent pharmacopeial (USP, EP) and ICH guidelines.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Process Chemistry Research: Aids in optimizing synthesis and purification processes to minimize the formation of this specific impurity.

Basic Information

Product Name	Tofacitinib Impurity K
CAS No.	2328165-36-0
Molecular Formula	C16H21N5O3
Molecular Weight	331.37 g/mol
Synonyms	CP-690550 Impurity K; (3R,4R)-4-Methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)-β-oxo-1-piperidinepropanenitrile; Tofacitinib Related Compound K; Tofacitinib EP Impurity K; Tofacitinib USP Impurity K; 1-Piperidinepropanenitrile, 4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)-β-oxo-, (3R,4R)-
EINECS	Contact for details

Quality Control

Our Tofacitinib Impurity K is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, related substance analysis, and structural confirmation (NMR, MS) to ensure identity and purity. Certificates of Analysis (COA) are provided, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH Q3A/B guidelines. We support GMP-grade requirements for pharmaceutical reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The product is light-sensitive (store away from light).

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)	Individual unknown impurity: ≤ 1.0% 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.