Description

Tofacitinib Impurity 102 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) Tofacitinib, a Janus kinase (JAK) inhibitor. It is an essential tool for researchers and quality assurance professionals in pharmaceutical companies, contract research organizations (CROs), and analytical laboratories focused on method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification in Tofacitinib API and finished dosage forms.
• Analytical Method Development and Validation (HPLC, UPLC, LC-MS) for accurate quantification of process-related impurities.
• Quality Control and Release Testing to ensure API batches meet stringent pharmacopeial (USP, EP) and ICH Q3A/B guidelines.
• Stability Studies to monitor impurity formation and degradation pathways under various storage conditions.
• Regulatory Submissions as a characterized reference material for New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), and other global regulatory filings.
• Research and Development of Tofacitinib synthesis processes to understand and control impurity formation.

Basic Information

Product Name	Tofacitinib Impurity 102
CAS No.	1615709-90-4
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 Related Compound 102; CP-690550 Impurity 102; (3R,4R)-4-Methyl-3-(methylamino)-1-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-N-(2-oxo-2-cyanoethyl)piperidine-1-carboxamide; Tofacitinib Nitrile Impurity; Xeljanz Impurity 102
EINECS	Contact for details

Quality Control

Every batch of Tofacitinib Impurity 102 is manufactured and tested under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances. Certificates of Analysis (COA) are available upon request, providing full traceability and supporting compliance with cGMP and ICH guidelines for pharmaceutical reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Due to its hygroscopic nature, the container should be kept tightly sealed and stored with desiccant to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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