Description

Tofacitinib Impurity 45 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Tofacitinib. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies. The availability of a well-characterized impurity standard is essential for maintaining stringent quality control in drug development and production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Tofacitinib Impurity 45 in drug substance and drug product analysis.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity levels throughout the drug lifecycle.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary data for impurity identification and qualification reports required by regulatory agencies like the FDA and EMA.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (thermal, photolytic, hydrolytic).
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Tofacitinib.

Basic Information

Item	Details
Product Name	Tofacitinib Impurity 45
CAS No.	2407039-29-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tofacitinib Related Compound 45; Tofacitinib EP Impurity J; Tofacitinib USP Impurity; CP-690550 Impurity 45; (3R,4R)-4-Methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)-β-oxo-1-piperidinepropanenitrile Impurity; Xeljanz Impurity 45; Janus Kinase (JAK) Inhibitor Impurity
EINECS	Contact for details

Quality Control

Every batch of Tofacitinib Impurity 45 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Comprehensive characterization is performed using advanced analytical techniques including HPLC, GC, MS, and NMR. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming identity, purity, and traceability. Our quality systems are designed to support compliance with ICH Q3A, Q3B, and cGMP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store the product in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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