Description

Tofacitinib Impurity 85 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient, Tofacitinib Citrate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, stability studies, and impurity profiling. The availability of a well-characterized impurity standard is essential for maintaining stringent quality control in drug production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Tofacitinib Impurity 85 in drug substances and products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods for impurity detection in Tofacitinib API and formulations.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing to ensure impurity levels are within ICH/USP/EP specified limits.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity profiles and justify specification limits.
• Research & Development: Used in pharmacokinetic, metabolic, and toxicological studies to understand the fate and impact of this impurity.

Basic Information

Product Name	Tofacitinib Impurity 85
CAS No.	2268720-86-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tofacitinib Related Compound 85; 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; Tofacitinib Degradant; Xeljanz Impurity 85; CP-690550 Impurity 85
EINECS	Contact for details

Quality Control

Every batch of Tofacitinib Impurity 85 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. 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)	Any individual impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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