Description

Abrocitinib Related Compound 3 is a high-purity chemical reference standard, specifically identified as a related substance of the active pharmaceutical ingredient Abrocitinib. This compound is critical for analytical method development, validation, and quality control processes in pharmaceutical research and manufacturing. It is primarily utilized by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories engaged in the development and production of JAK inhibitor therapeutics.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of specific impurities in Abrocitinib drug substance and finished dosage forms.
• Analytical Method Development and Validation: Used as a critical system suitability component to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for purity and stability-indicating assays.
• Stability Studies and Forced Degradation: Employed as a marker to monitor the formation of related substances during stability testing and forced degradation studies of Abrocitinib.
• Quality Control and Release Testing: Acts as a primary standard in quality control laboratories to ensure batch-to-batch consistency and compliance with regulatory specifications for impurity limits.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to characterize and justify impurity limits in accordance with ICH Q3A and Q3B guidelines.
• Chemical Research and Synthesis: Used as an intermediate or a building block in advanced chemical synthesis for developing novel JAK inhibitor analogs or for metabolic studies.

Basic Information

Product Name	Abrocitinib Related Compound 3
CAS No.	1622980-99-7
Molecular Formula	C14H17N5O
Molecular Weight	271.32 g/mol
Synonyms	PF-04965842 Related Compound 3; (3R,4R)-4-Ethyl-3-(4-methyl-1H-imidazol-1-yl)-N-(2-methyl-1H-pyrazol-3-yl)pyrrolidine-1-carboxamide; 1-[(3R,4R)-4-Ethyl-1-[(2-methyl-1H-pyrazol-3-yl)carbamoyl]pyrrolidin-3-yl]-4-methyl-1H-imidazole; Abrocitinib Impurity; Abrocitinib Related Substance 3
EINECS	Contact for details

Quality Control

Every batch of Abrocitinib Related Compound 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled under dry conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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