Description

Tofacitinib n-Hydroxy Impurity (CAS No. 2459302-76-0) is a high-purity reference standard critical for the analytical profiling and quality control of the active pharmaceutical ingredient, Tofacitinib Citrate. This impurity is essential for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is primarily used in research and development, method validation, and stability studies for the JAK inhibitor class of drugs.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of the n-Hydroxy impurity in Tofacitinib Citrate drug substance and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating stability-indicating HPLC/UPLC methods in accordance with ICH Q2(R1) guidelines.
• Quality Control & Batch Release Testing: Employed in routine QC laboratories to monitor impurity levels against strict pharmacopeial and internal specification limits.
• Stability Studies & Forced Degradation: Serves as a marker to understand degradation pathways and establish shelf-life for Tofacitinib-based pharmaceutical products.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Process Chemistry Research: Used to study and optimize synthetic routes to minimize the formation of this specific impurity during API manufacturing.

Basic Information

Product Name	Tofacitinib n-Hydroxy Impurity
CAS No.	2459302-76-0
Molecular Formula	C16H20N6O2
Molecular Weight	328.37 g/mol
Synonyms	N-Hydroxy Tofacitinib; Tofacitinib N-Oxide; Tofacitinib Hydroxylamine Impurity; CP-690550 n-Hydroxy Impurity; 3-((3R,4R)-4-Methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxopropanenitrile N-Oxide; Tofacitinib Related Compound H (potential); Tofacitinib Metabolite M9 (structural analog).
EINECS	Contact for details

Quality Control

Every batch of Tofacitinib n-Hydroxy Impurity 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, MS, and NMR 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 for audit and regulatory support.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing at 2-8°C. Keep the container sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 2.0% w/w

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