Description

Tofacitinib Related Compound 2 CAS NO 1629858-78-1 is a high-purity chemical reference standard, specifically a key impurity and degradation product of the active pharmaceutical ingredient Tofacitinib. This compound is essential for analytical method development, validation, and quality control in pharmaceutical research and manufacturing. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories involved in the development and production of JAK inhibitor therapies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Tofacitinib drug substance and finished products.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, and LC-MS methods to ensure accurate impurity detection.
• Stability Studies: Employed to monitor the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Quality Control (QC) Testing: Acts as a system suitability standard and for routine batch release testing in GMP-compliant manufacturing environments.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control.
• Research and Development: Utilized in metabolic and pharmacokinetic studies to understand the degradation pathways of Tofacitinib.

Basic Information

Product Name	Tofacitinib Related Compound 2
CAS No.	1629858-78-1
Molecular Formula	C16H20N6O
Molecular Weight	312.37 g/mol
Synonyms	3-[(3R,4R)-4-Methyl-3-(methylamino)-1-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)piperidin-1-yl]-3-oxopropanenitrile; Tofacitinib Impurity 2; Tofacitinib Related Substance 2; CP-690550 Related Compound 2; (3R,4R)-4-Methyl-3-(methylamino)-1-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)piperidine-1-carboxylic acid cyanomethyl ester; Tofacitinib Degradant; Xeljanz Impurity 2
EINECS	Contact for details

Quality Control

Every batch of Tofacitinib Related Compound 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profile. We support compliance with ICH Q3A, Q3B, and USP guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The product is light-sensitive (store away from light). Keep the container tightly sealed in a dry environment to protect from moisture absorption.

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)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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