Description

Tofacitinib Impurity CAS NO 90953-01-8 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Tofacitinib, a Janus kinase (JAK) inhibitor. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) by providing a benchmark for identification and quantification. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing, enabling precise impurity profiling and method validation.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the identification and quantification of specific impurities in Tofacitinib API and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity detection.
• Stability Studies & Forced Degradation: Employed as a marker to monitor the formation of degradation products under various stress conditions (e.g., heat, light, humidity).
• Quality Control & Batch Release Testing: A critical component in the routine QC testing of Tofacitinib to ensure batches meet stringent pharmacopeial (USP, EP) and ICH guidelines for impurity limits.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive understanding and control of the API's impurity profile.
• Research on Metabolic Pathways: Can be utilized in studies investigating the metabolism and pharmacokinetics of Tofacitinib.

Basic Information

Product Name	Tofacitinib Impurity
CAS No.	90953-01-8
Molecular Formula	C16H20N6O
Molecular Weight	312.37 g/mol
Synonyms	CP-690550 Impurity; Tofacitinib Related Compound; 3-((3R,4R)-4-Methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxopropanenitrile; (3R,4R)-1-(2-Cyanoacetyl)-4-methyl-N-methyl-N-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)piperidine-3-carboxamide; Tofacitinib Nitrile Impurity; Tofacitinib Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Tofacitinib Impurity (CAS 90953-01-8) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques such as HPLC, GC, NMR, and mass spectrometry to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing all test results, including chromatographic purity, is provided with each shipment.

Storage

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

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)	≤ 0.5%

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