Description

Fedratinib Impurity 19 is a designated process-related impurity and a critical reference standard used in the analytical profiling of Fedratinib, a Janus kinase 2 (JAK2) inhibitor. This compound is essential for pharmaceutical research and development, enabling the identification, quantification, and control of this specific impurity during drug substance manufacturing. It is primarily required by analytical chemists, quality control laboratories, and regulatory affairs professionals within the pharmaceutical and biotechnology sectors to ensure product safety, efficacy, and compliance with stringent regulatory guidelines (e.g., ICH Q3A/B).

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the qualitative and quantitative analysis of Fedratinib drug substance and drug products.
• Method Development and Validation: Critical for developing, optimizing, and validating stability-indicating analytical methods, such as HPLC and UPLC.
• Impurity Profiling and Characterization: Used to establish impurity profiles, understand degradation pathways, and monitor process consistency in Fedratinib synthesis.
• Quality Control and Batch Release: Employed in routine QC testing to ensure impurity levels are within specified limits as per regulatory filings.
• Regulatory Submission Support: Provides essential data for Investigational New Drug (IND) and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Stability Studies: Used as a marker to assess the stability of Fedratinib under various stress conditions (e.g., heat, light, humidity).

Basic Information

Product Name	Fedratinib Impurity 19
CAS No.	956404-52-7
Molecular Formula	C27H30FN5O3
Molecular Weight	491.56 g/mol
Synonyms	Fedratinib Related Compound 19; Fedratinib EP Impurity J; Fedratinib USP Impurity; 1H-Pyrrolo[2,3-b]pyridine-5-carboxamide, N-[(1R,2S)-2-(3,5-difluorophenyl)cyclopropyl]-2-[(3R,5S)-3,5-dimethyl-1-piperazinyl]-4-(4-methyl-1-piperazinyl)-; TG101348 Impurity 19; SAR302503 Impurity 19
EINECS	Contact for details

Quality Control

Every batch of Fedratinib Impurity 19 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality assurance system is designed to meet the exacting standards of pharmaceutical reference material users. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests including HPLC purity, related substances, residual solvents, and spectroscopic confirmation (IR, MS, NMR). We support compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material is hygroscopic (moisture-sensitive); ensure the container is kept in a dry environment. 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 standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% 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.