Description

Tofacitinib Impurity T CAS NO 1092578-43-2 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 research institutions engaged in method development, stability studies, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for the identification and quantification of Tofacitinib Impurity T in drug substance and finished product analysis.
• Analytical Method Development and Validation: Used as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity detection.
• Quality Control and Assurance (QC/QA): Essential for routine batch release testing in API manufacturing to monitor and control impurity levels as per ICH guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Research and Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Tofacitinib.

Basic Information

Item	Detail
Product Name	Tofacitinib Impurity T
CAS No.	1092578-43-2
Molecular Formula	C16H20N6O
Molecular Weight	312.37 g/mol
Synonyms	N-[(3R,4R)-4-Methyl-1-(pyrimidin-2-yl)-4-piperidyl]-3H-imidazo[1,2-a]pyrrolo[2,3-e]pyrazin-8-amine; Tofacitinib Related Compound T; CP-690550 Impurity T; (3R,4R)-4-Methyl-1-(pyrimidin-2-yl)-N-(3H-imidazo[1,2-a]pyrrolo[2,3-e]pyrazin-8-yl)piperidin-4-amine; Tofacitinib EP Impurity T; Tofacitinib USP Impurity T; Tofacitinib Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Tofacitinib Impurity T is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to meet the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests including HPLC purity, NMR, and mass spectrometry for structural confirmation.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

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%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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