Description

Baricitinib Impurity 1 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Baricitinib. This high-purity compound is critical for ensuring the safety and efficacy of the final drug product by enabling accurate identification and quantification of process-related impurities. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control of Baricitinib API and finished dosage forms.
• Analytical Method Development & Validation: Used to establish and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) to demonstrate comprehensive impurity control.
• Stability Studies: Employed as a marker to monitor impurity formation in stability-indicating studies of Baricitinib under various storage conditions.
• Process Chemistry Research: Aids in the identification and tracking of this specific impurity during API synthesis process optimization and scale-up.
• Pharmacopoeial Testing: Used as a system suitability and identification standard in compliance with pharmacopoeial monographs.

Basic Information

Product Name	Baricitinib Impurity 1
CAS No.	2964606-44-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Baricitinib Related Compound 1; Baricitinib Impurity; 1-(Ethylsulfonyl)-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]azetidine-3-carbonitrile; Azetidine-3-carbonitrile, 1-(ethylsulfonyl)-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]-; Baricitinib Process Impurity; Baricitinib Specified Impurity
EINECS	Contact for details

Quality Control

Our Baricitinib Impurity 1 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using advanced techniques such as HPLC, NMR, and MS to confirm identity and ensure high purity. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results. Our quality standards are designed to meet the rigorous requirements of pharmaceutical reference material applications.

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. The material should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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