Description

Tofacitinib Impurity 6 is a designated process-related impurity and degradation product of the active pharmaceutical ingredient Tofacitinib Citrate. This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is essential for researchers and quality assurance professionals in the pharmaceutical and biotechnology industries who require reliable materials for ensuring drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Tofacitinib Impurity 6 in drug substance and finished product analysis.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to establish and validate chromatographic methods for impurity profiling in accordance with ICH Q2(R1) and Q3A(R2) guidelines.
• Stability Studies & Forced Degradation: Employed as a marker to monitor the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity, acid/base).
• Quality Control & Batch Release Testing: Serves as a system suitability and identification standard in the routine QC testing of Tofacitinib API and its formulations to ensure batch-to-batch consistency.
• Regulatory Submissions: Provides essential data for filing regulatory documents (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Research & Development: Used in R&D laboratories to study the chemical behavior, formation pathways, and toxicological profile of this impurity.

Basic Information

Product Name	Tofacitinib Impurity 6
CAS No.	1640972-35-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(3R,4R)-4-Methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)-β-oxo-1-piperidinepropanenitrile; Tofacitinib Related Compound 6; Tofacitinib Degradant; CP-690550 Impurity 6; Xeljanz Impurity 6
EINECS	Contact for details

Quality Control

Our Tofacitinib Impurity 6 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity determination, residual solvent analysis, and structural confirmation (NMR, MS), to ensure identity, purity, and traceability. Certificates of Analysis (COA) containing detailed test results are provided and are available upon request to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

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)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
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.