Description

Tofacitinib Related Compound 16 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical products by serving as a benchmark in impurity profiling and method validation studies. It is primarily needed by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in the development and quality control of Janus kinase (JAK) inhibitor drugs.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Tofacitinib Citrate active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing, calibrating, and validating chromatographic methods, such as HPLC and UPLC, to ensure regulatory compliance.
• Quality Control (QC) & Quality Assurance (QA): Employed in routine batch release testing within pharmaceutical QC laboratories to monitor and control impurity levels against established specifications.
• Stability Studies: Used to track the formation of degradation products in Tofacitinib formulations under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.
• Research & Development: Supports synthetic chemistry research for process optimization and the development of new synthetic routes for JAK inhibitors.

Basic Information

Item	Details
Product Name	Tofacitinib Related Compound 16
CAS No.	2183519-70-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tofacitinib Impurity 16; Tofacitinib Related Substance 16; Tofacitinib Citrate Related Compound 16; CP-690550 Related Compound 16; (3R,4R)-4-Methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)-β-oxo-1-piperidinepropanenitrile Related Compound; JAK Inhibitor Related Compound 16; Xeljanz Impurity 16
EINECS	Contact for details

Quality Control

Our Tofacitinib Related Compound 16 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and conformity to the highest standards. A comprehensive Certificate of Analysis (COA) detailing purity, assay, and impurity profile is provided with every shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption. 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)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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