Description

Tofacitinib Impurity 19 is a specified organic impurity associated with the active pharmaceutical ingredient Tofacitinib Citrate, a Janus kinase (JAK) inhibitor. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is primarily used by analytical chemists, quality assurance professionals, and researchers in pharmaceutical companies and contract research organizations (CROs) to ensure the purity, safety, and efficacy of Tofacitinib-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Tofacitinib Impurity 19 in drug substance and drug product batches.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles during stability studies.
• Quality Control & Batch Release: Employed in routine QC testing to ensure impurity levels comply with International Council for Harmonisation (ICH) Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH Q1A(R2).
• Regulatory Submissions: Supports the filing of regulatory documents (e.g., Drug Master Files, Common Technical Documents) by providing impurity characterization and control data.
• Process Chemistry Research: Aids in understanding the formation pathway of this impurity during the synthesis of Tofacitinib, helping to optimize manufacturing processes.

Basic Information

Product Name	Tofacitinib Impurity 19
CAS No.	2056104-91-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tofacitinib Related Compound 19; Tofacitinib Citrate Impurity 19; (3R,4R)-4-Methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)-β-oxo-1-piperidinepropanenitrile; CP-690550 Impurity 19; Tofacitinib Degradation Product 19; Tofacitinib Process Impurity 19; Tofacitinib Specified Impurity 19
EINECS	Contact for details

Quality Control

Our Tofacitinib Impurity 19 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity, identity confirmation (by IR and/or MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every 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 (typically 15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
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.