Description

Tofacitinib Impurity 191 is a high-purity chemical reference standard used in the analytical profiling of the active pharmaceutical ingredient, Tofacitinib. This compound is critical for ensuring the quality, safety, and regulatory compliance of Tofacitinib drug substances and products by serving as a benchmark for identification and quantification. It is an essential material for pharmaceutical R&D laboratories, quality control units, and regulatory affairs departments focused on method development, validation, and impurity control strategies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Tofacitinib and related drug products.
• Impurity Profiling & Identification: Critical for identifying and characterizing process-related impurities and degradation products in Tofacitinib batches.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, and LC-MS methods for impurity detection and assay.
• Quality Control & Release Testing: Employed in routine QC testing to monitor impurity levels against established specifications, ensuring batch-to-batch consistency.
• Regulatory Compliance & Filings: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary data on impurity structure, qualification, and control limits.
• Stability Studies: Used as a marker to track the formation of specific impurities during forced degradation and long-term stability studies of Tofacitinib formulations.

Basic Information

Product Name	Tofacitinib Impurity 191
CAS No.	1638499-36-1
Molecular Formula	C16H20N6O
Molecular Weight	312.37 g/mol
Synonyms	3-[(3R,4R)-4-Methyl-3-(methylamino)-1-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)piperidin-1-yl]-3-oxopropanenitrile; Tofacitinib Related Compound 191; CP-690550 Impurity 191; Tofacitinib Nitrile Impurity; (3R,4R)-4-Methyl-3-(methylamino)-1-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)piperidine-1-carbonylacetonitrile
EINECS	Contact for details

Quality Control

Every batch of Tofacitinib Impurity 191 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, LC-MS, NMR) to ensure compliance with pharmacopeial and industry standards for reference materials. 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. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
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.