Description

Tofacitinib Impurity 77 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 ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification during pharmaceutical development and manufacturing. It is an essential material for analytical chemists and quality assurance professionals in the pharmaceutical industry, particularly those involved in method validation, stability studies, and impurity characterization for Janus kinase (JAK) inhibitor therapeutics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quantitative and qualitative analysis of Tofacitinib API.
• Method Development and Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS analytical methods to monitor impurity levels.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Tofacitinib drug substance and drug products meet stringent ICH guidelines for impurity thresholds.
• Stability Studies: Employed to identify and track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity profiles and justify specification limits.
• Research and Development: Supports process chemistry research to understand impurity formation pathways and optimize synthesis routes for cleaner API production.

Basic Information

Product Name	Tofacitinib Impurity 77
CAS No.	1640971-51-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tofacitinib Related Compound 77; Tofacitinib EP Impurity G; Tofacitinib USP Impurity; CP-690550 Impurity 77; (3R,4R)-4-Methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)-β-oxo-1-piperidinepropanenitrile Impurity; Janus Kinase Inhibitor Impurity; Xeljanz Impurity
EINECS	Contact for details

Quality Control

Every batch of Tofacitinib Impurity 77 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques (HPLC, LC-MS, NMR) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming conformity to client specifications or in-house reference standards.

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. For long-term storage, consider storing desiccated under inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference retention time
Identification (MS)	Conforms to reference mass spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.