Description

Tofacitinib Impurity 36 is a high-purity chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Tofacitinib. This impurity is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily utilized by professionals in pharmaceutical development, quality assurance (QA), and quality control (QC) for method validation and impurity identification studies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of Tofacitinib.
• Method Development and Validation: Essential for developing and validating analytical methods, particularly HPLC and UPLC, to monitor impurity levels.
• Quality Control & Assurance (QC/QA): A critical component in the batch release testing of Tofacitinib API to ensure it meets stringent pharmacopeial specifications (e.g., ICH Q3A/B).
• Stability Studies: Employed to identify and track the formation of this specific impurity during forced degradation and long-term stability studies of drug substances and products.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and justify specifications.
• Research and Development (R&D): Used in synthetic chemistry research to understand degradation pathways and to synthesize purer batches of the API.

Basic Information

Product Name	Tofacitinib Impurity 36
CAS No.	2250241-69-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tofacitinib Related Compound 36; Tofacitinib EP Impurity 36; Tofacitinib USP Impurity 36; (3R,4R)-4-Methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)-β-oxo-1-piperidinepropanenitrile; Xeljanz Impurity 36; CP-690550 Impurity 36; Tofacitinib Degradant
EINECS	Contact for details

Quality Control

Every batch of Tofacitinib Impurity 36 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to meet the exacting standards of pharmaceutical impurity supply, supporting compliance with ICH guidelines and relevant pharmacopeias. 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 at controlled room temperature (15-25°C) or as indicated on the label or COA. The material should be kept in a dry environment to prevent moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 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.