Description

Tofacitinib Impurity 29 is a designated impurity of the active pharmaceutical ingredient (API) Tofacitinib Citrate, a Janus kinase (JAK) inhibitor. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is essential for manufacturers, analytical laboratories, and regulatory bodies involved in ensuring the purity, safety, and efficacy of Tofacitinib-based drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Tofacitinib Impurity 29 in drug substances and products.
• Analytical Method Development: Crucial for developing and optimizing chromatographic methods (HPLC, UPLC) to separate and detect this specific impurity.
• Quality Control & Assurance: Used in routine batch testing to monitor impurity profiles and ensure compliance with ICH Q3A/B guidelines and regulatory specifications.
• Stability Studies: Employed to track the formation of this impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Supports the filing of regulatory documents (e.g., DMF, CMC sections) by providing necessary impurity characterization data.
• Process Chemistry Research: Aids in understanding the formation pathway during API synthesis, helping to refine manufacturing processes to minimize impurity levels.

Basic Information

Product Name	Tofacitinib Impurity 29
CAS No.	1638499-35-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(3R,4R)-4-Methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)-β-oxo-1-piperidinepropanenitrile; Tofacitinib Related Compound 29; Tofacitinib Citrate Impurity 29; CP-690550 Impurity 29; Xeljanz Impurity 29; 1-Piperidinepropanenitrile, 4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)-β-oxo-, (3R,4R)-
EINECS	Contact for details

Quality Control

Our Tofacitinib Impurity 29 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic (HPLC/UPLC) and spectroscopic (NMR, MS) techniques, to ensure identity, purity, and traceability. We provide comprehensive Certificates of Analysis (COA) with detailed chromatograms and spectral data, supporting compliance with ICH, USP, and EP guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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