Description

Barcitinib Impurity-09 is a designated process-related impurity and reference standard used in the pharmaceutical development and quality control of Baricitinib, a Janus kinase (JAK) inhibitor. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the final Active Pharmaceutical Ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the qualitative and quantitative analysis of Baricitinib API and drug products.
• Method Development and Validation (HPLC/LC-MS): Essential for developing and validating chromatographic methods to monitor and control impurity levels during manufacturing.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to identify and track impurity profiles over time.
• Quality Control & Batch Release: A critical component in the QC testing of Baricitinib to ensure batches meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Research and Development: Used in synthetic route optimization and process chemistry to understand and minimize impurity formation.

Basic Information

Product Name	Barcitinib Impurity-09
CAS No.	1187594-16-6
Molecular Formula	C16H17N7O2S
Molecular Weight	371.42 g/mol
Synonyms	Baricitinib Impurity 09; Baricitinib Related Compound 09; 2-[(1S)-1-(Ethylsulfonyl)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)propyl]-4-(4-methylpiperazin-1-yl)benzonitrile; 4-[4-(4-Methyl-1-piperazinyl)phenyl]-2-[[(1S)-1-(ethylsulfonyl)-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propyl]amino]benzonitrile (process-related isomer); LY3009104 Impurity-09; Olumiant Impurity-09
EINECS	Contact for details

Quality Control

Every batch of Barcitinib Impurity-09 (CAS 1187594-16-6) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming conformity to client specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

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)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
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.